DDrare: Database of Drug Development for Rare Diseases

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = -aminosalicylic acid; 0,25 mg RPC1063; 0.25 mg RPC1063; 0114-0006B; 10 mg; 10% Metronidazole Ointment; 1000 IU D3; 13-valent pneumococcal conjugated vaccine (PCV13); 18F-FDG; 1mg RPC1063; 2'-Fucosyllactose; 23-valent polysaccharide pneumococcal vaccine; 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM); 25 mg Ontamalimab; 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III); 331731-18-1; 4-Aminosalicylic acid; 4-Aminosalicylic acid extended release granules; 40 mg; 40 mg MSB11022; 42942019; 5-ASA; 5-Aminosalicyl acid; 5-Aminosalicylic acid; 5-HTP; 5-aminolevulinic acid; 5-aminosalicylate (Pentasa, Ferring); 5-aminosalicylic acid; 5000 IU D3; 549-0261/F02-01; 6 Mercaptopurine; 6 mercaptopurine; 6-MP; 6-Mercaptopurine; 6-Mercaptopurine (Puri-Nethol); 6-Mercaptopurine (Puri-nethol); 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine; 683699; 75 mg Ontamalimab; 80 mg DR-6MP; 99mTc-S-HYNIC Certolizumab pegol; ?-3 polyunsaturated fatty acid; A fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine; A-1293543.74; AB1010; ABBV-066; ABR-215062 sodium salt; ABT 494 12mg; ABT 494 3mg; ABT Humira; ABT-494; ABT-874; ABX464; ADALIMUMAB; ADSVF; AIN457; ALBUMINE HUMAINE; ALLO-ASC; ALLO-ASC-CD; ALLOPURINOL; ALLOPURINOL SODIUM; ALX-0600; AMG 139; AMG 181; AMG 827; AMG 827 210 MG; AMG 827 350 MG; AMG 827 700 MG; AMGEVITA (Adalimumab biosimilar ); AMGEVITA®; AMINOSALICYLIC ACID; AN100226; APD334; APD371; AR401959 L-arginine; AS; ASA; ASC; ASCs; ASCs: Adipose derived Stem Cells; AST-120; ATG; AZA; AZATHIOPRINE; AZATHIOPRINE or METHOTREXATE; AZD9056; AZITHROMYCIN; Abatacept; Abrilumab; Accelerated 1 hour-infusion; Accelerated 30 minutes-infusion; Acetaminophen; Acetate; Adalimumab; Adalimumab (40 mg); Adalimumab (D2E7); Adalimumab 40 mg eow or ew; Adalimumab Injection; Adalimumab PRN; Adalimumab and Infliximab; Adult human mesenchymal stem cells; Agri-King Synbiotic (AKSB); Albendazole; Albendazole (Eskazole); Albumen; Aldesleukin; Alemtuzumab; Alequel; Alfacalcidol; Alicaforsen; Alicalm (polymeric liquid formula); Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs); Allogeneic Stem Cell Therapy; Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601; Allogenic eASCs 5 million cells/ml suspension for injection CX601; Allogenic eASCs 5 million cells/ml suspension for injection. CX601; Allogenic eASCs 5 million/ml suspension for injection.; Allopurinol; Allopurinol Sandoz 100 mg, tabletten; Alofisel; Amgevita; Amgevita 40 mg Injektionslösung im Fertigpen; Amgevita 40 mg Injektionslösung in einer Fertigspritze; Amgevita 40Mg Solution for Injection; Aminolevulinic acid; Aminosalicylic acid; Ammonium chloride; Amoxicillin; Andecaliximab; AndoSan; Anti TNF; Anti TNF Alfa.; Anti TNF humanized antibody Fab fragment-PEG conjugate; Anti TNF therapy including infliximab; Anti-CD3; Anti-CD3 Monoclonal antibody; Anti-IL-12; Anti-IL-23 monoclonal antibody; Anti-IL-6 mAb; Anti-Interferon-gamma monoclonal antibody; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; Anti-Interleukin-6 Monoclonal Antibody; Anti-MAdCAM antibody; Anti-TNF; Anti-TNF Drug; Anti-TNF Therapy; Anti-TNF discontinuation: Physiological saline solution; Anti-TNF: Infliximab (Infusion); Anti-TNF:Adalimumab (Subcutaneus); Anti-thymocyte globulin (rabbit); Anticorpo monoclonale anti IL-23; Anticorpo monoclonale anti-IL-23; Antithymocyte immunoglobulin; Antithymocyte immunoglobulin (rabbit); Apixaban; Apixaban 2.5 milligram; Application of Adalimumab; Arginine; Atorvastatin; Autologous ADIpose derived stromal vascular fraction; Autologous CD34-selected peripheral blood stem cells transplant; Autologous Stem Cell Transplantation; Autologous mesenchymal stromal cell; Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population; Azathioprin; Azathioprin-ratiopharm 25 mg; Azathioprin-ratiopharm 25mg Filmtabletten; Azathioprin-ratiopharm 50 mg Filmtabletten; Azathioprine; Azathioprine (AZA) caps; Azathioprine (AZA) or 6-mercaptopurine (6-MP); Azathioprine - ratiopharm 50 mg; Azathioprine / 6 Mercaptopurine; Azathioprine OR Mesalazine; Azathioprine in case of endoscopic recurrence; Azathioprine individualised dose; Azathioprine or 6-mercaptopurine; Azathioprine or adalimumab and infliximab; Azathioprine weight-based dose; Azathioprine+enteral nutrition; Azatioprina; Azithromycin; Azithromycin + Metronidazole; B. theta; BFAHF-2; BI 655066; BI 655066 10 mg/ml; BI 655066 90 mg/ml; BI 655130; BI 695501; BIBR 796 BS, 20 mg; BIBR 796 BS, 5 mg; BLI-1300 high dose; BLI-1300 low dose; BMS-188667; BMS-936557; BMS-936557 (Anti-IP-10 Antibody); BMS-945429; BMS-986165; BMS986165; BRAZIKUMAB; BT-11; BT-11 1,000 mg; BT-11 1000mg; BT-11 500 mg; BT-11 Active; BUDESONIDE; Bacteriophage preparation; Bacteriotherapy; Bean; Behavioral: AbbVie Care 2.0; Behavioral: Diet Counseling; Behavioral: Dyadic Psychological Support (DPS); Behavioral: Hypnosis; Behavioral: TIP / IMPACT Plus Care Coordination; Beta carotene; Beta carotene from Dunaliella algae; Betamethasone; Bezlotoxumab; Bifidobacterium infantis; Bifidobacterium infantis 35624; Biological samplings; Biosimilar; Biosimilar infliximab; Bleomycin; Blood and stools samples; Blood sampling; Bone Marrow Derived Mesenchymal Stem cells (MSCs); Boulardii; Brazikumab; Brazikumab IV Infusion; Brazikumab SC Injection; Brazikumab high dose; Brazikumab low dose; Budenofalk; Budenofalk 3mg gastro-resistant capsules; Budenofalk 9mg gastro-resistant granules; Budesonide; Budesonide ( Zentacort Capsules 3mg ); Bupivacaine; Bupivacaine/epinephrine/dexamethasone; Bupropion; By demand; C326, IL-6 Inhibitory Avimer protein; CC; CC-5013; CCX282-B; CD; CDP6038; CDP870; CERTOLIZUMAB PEGOL; CHENODEOXYCHOLIC ACID; CHLORURE DE SODIUM; CHOLECALCIFEROL; CHOLECALCIFEROL CONCENTRATE; CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM); CLARITHROMYCIN; CLOFAZIMINE; CNTO 1275; CNTO1275; CNTO1959; CP; CP-461; CP-690,550; CP-690,550-10; CPSI-2364; CROWN; CT-P13; CT-P13 SC (Infliximab); CTLA4Ig; CURCUMA LONGA RHIZOMA; Caffeine; Caffeine 100 mg; Calcitonin nasal spray (salmon); Calcitriol; Calcium; Calcium Carbonate; Calcium carbonate; Caltrate Pill; Cannabidiol; Cannabidiol , synthetic form; Cannabis; Cannabis, Medical; Carbon; Carbonate; Carnitine; Celebrex; Cellulose; Certican; Certolizumab; Certolizumab Pegol; Certolizumab Pegol (CDP870); Certolizumab Pegol /Cimzia; Certolizumab pegol; Certolizumab pegol (CDP870); Certolizumab pegol (CDP870, CZP); Certolizumab pegol (CZP); Certolizumab pegol (rINN); Certolizumab pegol 400 mg; ChAdOx2 HAV; Chenodeoxycholic acid; Chenodiol; Chenofalk; Chimeric IgG1 monoclonal antibody; Chloride; Chlorure de sodium; Cholecalciferol; Cholecalciferol 10,000 IU; Cholecalciferol 400 IU; Cholestagel; Chondroitin sulfate; Cimzia; Cimzia 200 mg solution for injection; Ciprofloxacin; Ciprofloxacin hydrochloride; Clarithromycin; Clofarabine; Clofazimine; Coffee; Colecalciferol; Colecalciferol D3 (Vigantol Oil); Colesevelam; Colony-purified Bacteroides thetaiotaomicron (B.theta); Contrast enhanced ultrasound; Cortecosteroid; Corticosteroid; CosmoFer; CosmoFer 50mg/ml solution for infusion or injection; Crohn's Disease; Crohns Disease Exclusion Diet + PEN; Curcuma; Curcuma Longa; Curcumin; Cx401; Cx601; Cyclophosphamide; Cyclophosphamide monohydrate; Cyltezo; Cytochrome P450 (CYP) Substrates; Cytoxan; D-CURA; D-Cura; D9421-C; D9421-C capsule 3 mg; D9421-C, 15mg; D9421-C, 9mg; DARVADSTROCEL; DB adalimumab 40 mg eow; DB adalimumab 40 mg ew; DHEA; DLX105; DOXYCYCLINE; DOXYCYCLINE HYCLATE; Darvadstrocel; Decortin 20 mg; Decortin 5 mg; Dehydroepiandrosterone; Dehydroepiandrosterone [DHEA]; Dekristol 20.000 ie; Delayed Release 6 mercaptopurine; Delayed Release 6MP or Calcitriol vs. Purinethol; Denosumab; Device: Capsule endoscopy; Device: Contrast Enhanced Ultrasound; Device: Endopath from Itamar medical - FDA approved device.; Device: Fluorescence endoscopy and spectroscopy; Device: Magnetic Resonance Enterography (MRE); Device: PMA-zeolite; Device: Ultrasound Elastography; Device: Ultrasound Imaging; Device: Ultrasound Vascularity; Device: cellulose; Dexametasona; Dexamethasone; Dexamethasone sodium phosphate; Dexamethasone sodium phosphate 250 mg/ 10 ml; Dextran; Dextromethorphan; Dextromethorphan 30 mg; Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT; Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels; Diet 1; Diet 2; Dietary therapy; Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon; Diflucan; Diphenhydramine; Doxycycline; E-Device; E6011; E6011 10 mg/kg; E6011 15 mg/kg; E6011 2 mg/kg; E6011 5 mg/kg; EB8018; EB8018 (First-in-class FimH blocker); EEN; EEN intervention group; EFALIZUMAB; EGG WHITE PROTEIN; EMEA/H/C/000240; EMEA/H/C/002778; ENDOXAN BAXTER; ENTYVIO; ERB-041; ERY-DEX; ETROLIZUMAB; EU/1/03/268/002; EU/1/99/116/003; Early immunosuppressants (azathioprine, methotrexate); Efalizumab; Egg; Egg Albumen Powder; Egg white; Eicosapentaenoic acid; Endoxan; Entecavir; Enteral nutrition; Enteral nutrition.; Entocort; Entocort CR; Entocort® Kapseln; Entyvio; Epanova; Epanova™ (Omega-3 Free Fatty Acids); Epaxal Berna (virosomal hepatitis A vaccine); Epinephrine; Ergocalciferol; Erythropoietin; Eskazole; Etiprednol dicloacetate; Etrasimod; Etrasimod L-arginine; Etrolizumab; Evaluation of biological predictive factors of clinical response to ustekinumab; Everolimus; Exclusive Enteral Nutrition; Exclusive Enteral Nutrition Therapy; Expanded allogenic adipose-derived adult stem cells; Expanded autologous adipose-derived adult stem cells (eASCs); Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs); Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs); Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue; Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs; Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs); FE 999301; FFP104; FILGOTINIB; FITC-Adalimumab; FLUCONAZOLE; FMT; FOS; Faecal Microbiota Transplantation; Fecal Microbial Transplantation; Fecal Microbial transplant; Fecal Microbiota Transplant; Fecal Microbiota Transplant (FMT); Fecal Microbiota Transplantation; Fecal Microbiota Transplantation (FMT); Fecal microbiota; Fecal microbiota transplantation; Ferric Carboxy Maltose; Ferric Maltol; Ferric carboxymaltose; Ferric maltol; Ferrous sulphate; Filgotinib; Filgrastim; Fish oil; Flagyl; Flixabi; Fluconazole; Fludarabine; Fludarabine Phosphate; Fludarabine phosphate; FolateScan (Technetium Tc 99mEC20); Fosfato sodico de dexametasona; Fosfomycin; Fully humanised, recombinant monoclonal antibody (IgG1); G-CSF; G321605; GED-0301; GLPG0634; GLPG1205; GOLIMUMAB; GS-5745; GS-6034; GSK1070806; GSK1605786; GSK1605786 500 mg; GSK1605786 ChemoCentryx: formulation A; GSK1605786 GSK direct-fill: formulation C; GSK1605786 GSK modified-process: formulation D; GSK1605786 GSK tablet: formulation E; GSK1605786 GSK: formulation B; GSK1605786 capsule; GSK1605786A; GSK2330811; GUSELKUMAB; Genetic: TPMT genotyping; Genetic: genetic analysis; Glatiramer; Glatiramer acetate; Glucose; Glutamine; Gold; Golimumab; Green Tea; Group 2 ustekinumab 130 mg; Group 3: ustekinumab approximately 6 mg/kg; Growth Hormone; Growth hormone; Guselkumab; Guselkumab Dose 1; Guselkumab Dose 2; Guselkumab Dose 3; Guselkumab Dose 4; Guselkumab Dose 5; HMPL-004; HMPL004-6599; HUMAN ALBUMIN AS MACROAGGREGATES; HUMAN PLASMA FOR FRACTIONATION; HUMIRA; HUMIRA (adalimumab); HUMIRA 40 mg solución inyectable en jeringa precargada; HUMIRA 40Mg Solution for Injection; HUMIRA ®; HUMIRA*SC 2SIR+F 40MG 0,8ML+2T; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE SULPHATE; Hematopoietic stem cell transplantation; Hepatitis A Vaccine; Herpes Zoster Vaccine; Hextend; High Oligosaccharide Group; High dose TSO; High-dose Cyclophosphamide; HuM291; Hulio; Human Anti-IL-12 Antibody; Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Human Placenta-Derived Cells PDA001 Intravenous Infusion; Human albumin; Human anti-IP10 monoclonal antibody; Human insulin; Humira; Humira (adalimumab original); Humira (adalimumab); Humira 20 mg solution for injection in pre-filled syringe; Humira 40 mg injekcní roztok v predplnené injekcní stríkacce; Humira 40 mg solution for injection in pre-filled pen; Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg/0.8 ml solution for injection; Humira 40mg/0.4ml pre-filled syringe; Humira 40mg/0.8ml solution for injection for paediatric use; Humira pre-filled PEN; Humira®; Hydroxide; Hydroxychloroquine; IGG2 ANTIBODIES; IL-2; IM90838; IMP will be labeled as ''PF-04236921 106mg/vial, Clonal SC lyophilized form''.; IMP will be labeled as PF-04236921 106mg/vial, Clonal SC lyophilized form; IMU-838; IMUREL; INFLIXIMAB; INTERLEUKIN 2; INTERLEUKIN-2; ITF 2357; ITF2357; Immune Ablation and Hematopoietic Stem Cell Support; Immunonutrition; Immunosuppressor/TNFalpha; Impact; Imraldi; Imuran; Imurel; Imurel 25 mg; InVita D3; Increlex; Increlex 10mg/ml solution for injection; Indocyanine green; Inflectra; Inflectra 100 mg powder for concentrate for solution for infusion; Infliximab; Infliximab (IFX alone); Infliximab (Remicade); Infliximab (Remicade): 100 mg of lyophilized infliximab; Infliximab 10 mg/kg; Infliximab 20 mg/kg; Infliximab 5 mg/kg; Infliximab 5 mg/kg body weight infused over 2 hours; Infliximab 5 mg/kg every 6 weeks; Infliximab 7 mg/kg every 8 weeks; Infliximab [infliximab biosimilar 3]; Infliximab and adalimumab; Infliximab and azathioprine combination at week 0; Infliximab and azathioprine combination at week 14; Infliximab infusion; Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab; Infliximab with azathioprine (IIFX + AZA); Infliximab+azathioprine; Infliximab, adalimumab, certolizumab pegol; Infliximab, azathioprine; Infliximab-Biosimilar; Infliximab-Innovator; Injection of iron; Innovator infliximab; Inositol; Interferon alfa; Interferon beta; Interferon beta-1a; Interleukin 2; Interleukin-11; Interleukin-2 (aldesleukin).; Intralipid; Intralipid 10%; Intralipid 20%; Inulin; Iron; Iron Sucrose; Iron sucrose; Iron sulphate; Iron sulphate 200mg coated tablets; Iron supplement 300-600 mg/day; Iron(III)- hydroxide dextran complex; J695; J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0; JNJ-40346527; JNJ-40346527-AAC; JNJ-64304500; JNJ-64304500-AAA; JNJ-67864238; Kanamycin; Kenacort; Kremezin; Kremezin®, Spherical Adsorptive Carbon; L 44; L-Carnitine; L-carnitine; L01BA; LDP-02; LY3074828; Lactated Ringers; Lactobacillus salivarius UCC118; Lactulose; Lactulose/Rhamnose solution; Lap TAP Bupivacaine/Epinephrine; Laquinimod; Laquinimod Capsules 0.5 mg; Laquinimod Cápsulas 0.5 mg; Leucine; Lipitor; Liposomal bupivacaine; Losartan; Low dose TSO; Low dose naltrexone; Low-dose IL-2 administration; Lumbar puncture; Lumentin 44; Lymphocyte immune globulin; MB-102; MDGN-002; MDX-1100; MEDI2070; MERCAPTOPURINE; MESALAZINE; METHOTREXATE; METHOTREXATE DISODIUM; METRONIDAZOLE; MICROBIOTA; MIRIKIZUMAB; MLN0002; MLN0002 (Vedolizumab); MLN0002 SC; MLN002; MODULEN IBD; MODULEN IBD (R) (specific Enteral Nutrition); MONOCLONAL ANTIBODY ANTI-IGG1; MSC; MSC injection 01; MSC injection 02; MSC treatment 01; MSC treatment 02; MSC-AFP; MT-1303; MTX; MVA; MVA HAV; Maltodextrin; Maltose; Mango; Mango polyphenolics; Mannitol; Mare´s milk; Masitinib; Masitinib mesylate; Mecasermin; Mecasermin [rDNA Origin] 10mg/ml solution; Medium chain triglycerides; Medium dose TSO; Melphalan; Mensa; Mercaptopurine; Mesalamine; Mesalamine, 5-aminosalicylic acid; Mesalazine; Mesalazine (Mesalamine); Mesalazine EC 500 mg; Mesalazine Sustained-Release Tablets; Mesalazine tablets; Mesalazine, Tripterygium glycosides; Mesenchymal Stem Cells; Mesenchymal Stem Cells (MSC); Mesenchymal Stromal Cells; Mesenchymal cell and fibroblast injection; Mesenchymal cell transplantation; Mesenchymal stem cells; Mesenchymal stem cells (MSCs); Mesenchymal stromal cells (MSC) for infusion; Mesna; Methacholine; Methotrexat; Methotrexate; Methotrexate injection; Methoxsalen; Methoxsalen +ECP; Methyl prednisolone; Methylprednisolone; Methylprednisolone or budesonide; Metoject; Metotrexat; Metronidazol; Metronidazole; Midazolam; Midazolam 2 mg; Midazolam 3 mg; Mirikizumab; Mobilization of stem cells to prepare for Leukapheresis; Moderate Oligosaccharide Group; Modulen; Mongersen; Monoclonal antibodies; Monoclonal antibody cA2; Mosapride; Movprep; Mycodigest supplement; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolic Acid; Mycophenolic acid; N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium; N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamidesodium; N.a.; NI-0401 (anti-CD3 mAB); NNC 0142-0000-0002; NNC0114-0006; NNC0142-0000-0002; NNC142-0002; NORMIX*AD 12CPR RIV 200MG; NSP001; Naltrexone; Naltrexone hydrochloride; Naltrexone-HCl; Nap; Natalizumab; Neomycin; Nessuno; Nitazoxanide; Nivolumab; None; None at this time; Normal Saline; Normix; Null; Nutraceutical Combination; Nutrition treat; Nutritional dietary intervention; NutropinAq 10mg/2ml solution for injection; NutropinAq®; OL adalimumab 40 mg; OPC-6535; OPC-6535(Tetomilast); OPS-2071; OPS-2071 150 mg; OPS-2071 300 mg; OPS-2071 600 mg; OZANIMOD; Oligofructose enriched inulin; Olokizumab; Olokizumab (OKZ); Omega-3; Omegaven; Omegaven 10%; Omeprazole; Omeprazole 20 mg; Omeprazole 40 mg; Only 1 arm: treatment with MSC-AFP; Ontamalimab; Optison; Orencia; Originator (legacy) drug; Other Biologic Therapies; Other Biological Agent; Other: 100% pomegranate juice; Other: 5-ASA Withdrawal; Other: Acute response to high-impact exercise; Other: Blood Test; Other: CD LFD; Other: CD-TREAT diet; Other: Coffee; Other: Control Diet; Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet); Other: Crohns Disease Exclusion Diet; Other: Diet-CD; Other: Exclusion Diet; Other: Exclusive Enteral Nutrition (EEN); Other: Exclusive enteral nutrition; Other: Fractional Exhaled NO (FENO); Other: Green tea (Camellia sinensis); Other: High energy / protein diet.; Other: High-impact exercise intervention; Other: Hyperbaric oxygen; Other: IV saline infusion; Other: Intensify treatment with the existing drug; Other: Laboratory Biomarker Analysis; Other: Lengthening adalimumab dosing interval; Other: Leukapheresis- Collection of stem cells; Other: Low n-6 PUFA Diet; Other: Measurement of drug (Adalimumab/Infliximab); Other: Methacholine Challenge Test; Other: NS; Other: Other Biologic Agents; Other: PCDAI; Other: Quality-of-Life Assessment; Other: Questionnaires; Other: Standard nutrition; Other: Standard of Care; Other: Stem Cell Transplant; Other: Threonine; Other: UC-MSCs by peripheral intravenous infusion; Other: enteral nutrition; Other: high performance liquid chromatography; Other: infliximab (IFX) infusion; Other: laboratory biomarker analysis; Other: normal diet; Other: surgery; Other: triangular test; Ova-Treg; Ovasave; Oxadrop; Oxygen; Ozanimod; Ozanimod hydrochloride; P28GST; PDA001; PEG; PENTASA Sachet; PF 06687234; PF-00547659; PF-00547659 SC injection; PF-04236921; PF-04236921 SC injection; PF-06651600; PF-06651600 50 mg; PF-06651600-15; PF-06700841; PF-06700841 25 mg; PF-06700841 5 mg; PF-06700841-15; PL 17901/0122; PL 20532/0012; PLAQUENIL; PREDNISONE; PROCHYMAL (remestemcel-L); PROCHYMAL adult human mesenchymal stem cells; PRV-6527; PRV-6527 (JNJ-40346527); PRV-6527(JNJ-40346527); PTG-200; PURINETHOL; Pectin; Pegylated interferon alfa; Pending; Pentasa; Pentasa Sachet 1 g; Pentasa Sachet 1 g prolonged release granules; Pentoxifylline; Peptidic+Probiotic; Peripheral Blood Stem Cell Infusion; Pharmacokinetics of certolizumab pegol; Phosphate; Phylloquinone; Phylloquinone (vitamin K1); Physician standard-of-care; Pioglitazone; Pioglitazone 15 mg; Placebo; Plantain NSP; Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI); Pnemovax; Pneumovax; Polaprezinc; Polyethylene Glycol 3350; Polyethylene glycol; Pomegranate; Postoperative 3-month exclusive enteral nutrition; Pravastatin; Prebiotics; Prednisolon; Prednisolon Jenapharm; Prednisolone; Prednisone; Preparative regimen 4-6 weeks after Leukapheresis; Prevenar 13; Previously referred to as MEDI2070 and AMG 139; Previously referred to as MEDI2070 and AMG 139, AGN-151-598; Probiotic; Probiotic - VSL#3; Probiotic Mixture; Probiotics; Procedure: Allogeneic Bone Marrow Transplantation; Procedure: Apheresis catheter placement; Procedure: Autologous stem cell transplant; Procedure: Blood sampling from infant; Procedure: Blood sampling from mother; Procedure: Blood sampling from umbilical cord; Procedure: Blue light photopheresis; Procedure: Breast milk sampling; Procedure: Computed Tomography; Procedure: Continuous Mononuclear Cell Collection (CMNC); Procedure: DEXA scan; Procedure: EUA with seton placement if necessary; Procedure: EUS; Procedure: Endoscopic balloon dilatation; Procedure: Extracorporeal Photopheresis; Procedure: FMT; Procedure: Ileocolonoscopy; Procedure: Instillation of fibrin glue; Procedure: Intestinal surgery for Crohn's Disease; Procedure: Leukapheresis; Procedure: Measurement of serum infliximab and anti-infliximab antibodies; Procedure: Positron Emission Tomography; Procedure: Routine drainage surgery; Procedure: Small bowel follow trough; Procedure: Transfusion; Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status; Procedure: WMT; Procedure: Whole body Protein turnover; Procedure: ileocecal resection; Procedure: lumbar puncture; Prochymal™ adult human mesenchymal stem cells; Promethazine; Prucalopride; Puri-Nethol; Puri-Nethol 50 mg; Purinethol; QAX567; QAX576; QBECO; QBECO-SSI; RAD001; RCTB-401; REMICADE; REMSIMA; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; REMSINA; RHB-104; RIFABUTIN; RIFAXIMIN; RIFAXIMINA; RISANKIZUMAB; RPC0163; RPC1063; RPC1063 (equivalent to ozanimod; RPC1063 (equivalent to ozanimod HCl); RR110 (Tamibarotene); RVG 05565; RVG 07151; Rabbit; Rabbit anti-human thymocyte immunoglobulin; Rabbit antithymocyte globulin; Racol; Radiation: Fluorine F 18 Clofarabine; Radiation: Total-Body Irradiation; Ranolazine; Rapamycin; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; RbATG; Received hormone maintenance therapy; Recombinant Human Interleukin-11 (rhIL-11); Recombinant growth hormone; Recombinant human Insulin-like Growth Factor; Remestemcel-L; Remicade; Remicade (infliximab); Remicade 100 mg; Remicade 100 mg powder for concentrate for solution for infusion.; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima; Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima and Inflectra; RhGH; RhIGF (Increlex); Rhamnose; RhumAb to Il-17A (IgG1-k-class); RhumAb to Il-17A (IgG1-k-class) rhumAb to Il-17A (IgG1-k-class); Ribavirin; Riboflavin; Riboflavin Sodium Phosphate Injection; Riboflavin supplementation; Rifabutin; Rifabutin, Clarithromycin, and Clofazimine; Rifaximin; Rifaximin Delayed Release (DR); Rifaximin EIR; Rifaximin delayed release 400 mg film coated tablet; Rifaximin delayed release tablets; Rifaximin+omeprazole+miralax; Rifaximin-EIR; Rifaximina; Risankizumab; Risankizumab 10 mg/ml; Risankizumab 180 mg SC; Risankizumab 600 mg IV; Risankizumab 90 mg/ml; Risankizumab IV; Risankizumab SC; Risedronate; Rituximab; Rizankisumab; Rizankizumab; Ro 549-0261/F04-02; Ro 549-0261/F08-02; Rosuvastatin; Rosuvastatin 10 mg; Routine Treatment of CD; S38; SB5; SC12267; SC12267 (4SC-101); SERUM ALBUMINE 5%; SHP647; SHR0302; SMOFLipid; SODIUM CHLORIDE; ST10; ST10-021; STA-5326; STA-5326 mesylate; STA-6838, STA-5326 m, S38; STELARA; STELARA 130 mg concentrate for solution for infusion; STELARA 90 mg solution for injection in pre-filled syringe; STELARA®; SUB20016; SULFUR HEXAFLUORIDE; Salmon; Salofalk; Salofalk 500 mg; Sandostatine; Sargramostim; Sargramostim (Leukine); Search for exocrine pancreatic insufficiency at week 0 and 12; Selective Immunosuppressive agents; Semapimod; Serum bovine immunoglobulin; Serum physiologique 0.9 %; Shingrix; Sibofimloc; Simethicone; Sivelestat; Smoflipid; Smoking cigarettes; Smoking of cannabis; Sodium chloride; Solid food-based intervention; Somatropin; Somatropin [rDNA origin] for injection; Somatropin(rhGH); SonoVue; Sonovue; Soy protein; Soya Bean oil; Spesolilmab; Spesolimab; Stable isotope infusions; Standard 2 hours-infusion; Standard step-up care; Start adalimumab in monotherapy; Stelara; Stelara 130 mg concentrate for solution for infusion; Stelara 90 mg solution for injection in pre-filled syringe; Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra; Stem cells; Step-up; Steroids; Stromal vascular fraction (SVF); Sucrose; Sugar Extract; Sulfate; Sulfur Hexafluoride; Sulfur hexafluoride; Sulphur hexafluoride; Suspension containing 250 embryonated, viable TSO/15ml; Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml; Suspension containing 2500 embryonated, viable TSO/15ml; Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml; Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml; Suspension of 7500 embryonated, viable TSO/15ml; Suspension of adipose derived autologous adult stem cells; Synbiotic (Synergy I / B.longum); T2; TA-650; TAK-018; TBC; TD-1473; THALIDOMIDE CELGENE - 50 MG CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PE/ACLAR/ALU) 28 CAPSULE; THC; THC 5mg/ml and CBS 50mg/ml; THRX-139060; THYMOGLOBULINE; TNF Kinoid; TNF-K; TNF-Kinoid; TNF-alpha antagonists; TNFa Kinoid; TNFa-Kinoid; TR004 (Treg immunotherapy); TRIAMCINOLONE; TRK-170; TSO 250; TSO 2500; TSO 7500; TU-100; TV-5600; Tacrolimus; Tamibarotene; Tasty&Healthy intervention group; Teduglutide; Teduglutide (ALX-0600); Teduglutide 0.05; Teduglutide 0.05 dose; Teduglutide 0.1 mg dose; Teduglutide 0.2 mg; Tetomilast; Thalidomide; Thalidomide Pharmion; The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.; The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA; The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA.; Thetanix; Thiopurine; Thiotepa; Threonine; Thymoglobulin; Thymoglobuline; Ticilimumab; Time and attention; Time and attention + active fructooligosaccharide supplementation; To be determined; To be requested; Tofacitinib; Tofacitinib (CP-690,550); Tolerogenic Dendritic Cells; Top-down; Treatment with Adalimumab; Triamcinolone; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (TSO); Trichuris trichiura eggs; Tripterygium; Tripterygium glycosides; Tris; UC-MSCs; URSODEOXYCHOLIC ACID; US TAP Bupivacaine/Epinephrine; USTEKINUMAB; UTTR1147A; UTTR1147A, IL22-Fc, IL-22Fc; UTTR1147A/RO7021610 (Active); UVADEX; UVADEX and UVAR XTS Photopheresis System; Ultrasound Microbubble Contrast Agent; Undetermined; Upadacitinib; UrsoFalk; UrsoFalk® 250 mg tabletten.; Ursodeoxycholic acid; Ustekinumab; Ustekinumab (6 mg/kg); Ustekinumab (90 mg); Ustekinumab 130 mg IV; Ustekinumab 1mg/kg (IP); Ustekinumab 3 mg/kg (IP); Ustekinumab 4.5 mg/kg; Ustekinumab 6 mg/kg (IP); Ustekinumab 90 mg; Ustekinumab 90 mg (SC) Group 1; Ustekinumab 90 mg (SC) Group 2; Ustekinumab 90 mg SC q12w; Ustekinumab 90 mg SC q8w; Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP); Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP); Ustekinumab IV Infusion; Ustekinumab SC Injection; Ustekinumab approximately 6 mg/kg (IV); Usual current care; Uvadex; V565; VEDOLIZUMAB; VIALEBEX; VSL#3; VSL#3 (Original De Simone formulation); VSL#3®; Vancomycin; Vedolizumab; Vedolizumab (Genetical Recombination); Vedolizumab 300 MG Injection [Entyvio]; Vedolizumab IV; Vedolizumab IV (Entyvio™); Vedolizumab IV 300 mg; Vedolizumab SC; Vedolizumab SC 108 mg; Vedolizumab intravenous injection; Vedolizumab subcutaneous injection; Vedolizumab-800CW; Vehice Control; Verapamil; Viagra; Vialebex 200mg; Vidofludimus; Vidofludimus calcium; Vigantol; Vigantol Oel; Vigantol Oel TM; Visilizumab; Vitamin D; Vitamin D drops; Vitamin D3; Vitamin D3 3000 UI daily; Vitamin D3 4000 UI daily; Vitamin D3 800 UI/day then 800 UI/day; Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day; Vitamin E; Vitamin E 800IU; Vitamin K; Vitamin K 10 mg; Vitamin K1; Vorinostat; WFI; WMT; Warfarin; Warfarin 10 mg; Water; Wellbutrin (bupropion); Whey protein; Xanthohumol; Z-206; ZP1848; Zessly; Zoledronic acid; [124I]IB PF 06687234; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F]FSPG; [Cx601]; [OPS-2071]; [RPC0163]; [RPC1063]; ÁCIDO GADOBÉNICO

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-002491-10-AT (EUCTR)	19/08/2020	11/05/2020	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czech Republic;Spain;Austria;Germany;United Kingdom
2	EUCTR2017-002491-10-FR (EUCTR)	17/07/2020	09/03/2020	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czech Republic;Spain;Austria;Germany;United Kingdom
3	EUCTR2017-002491-10-DE (EUCTR)	22/06/2020	09/03/2020	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom
4	EUCTR2019-000333-39-BE (EUCTR)	04/05/2020	21/01/2020	Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistula	A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
5	EUCTR2017-002491-10-CZ (EUCTR)	10/03/2020	27/11/2019	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czech Republic;Spain;Austria;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2019-000333-39-CZ (EUCTR)	15/10/2019	03/09/2019	Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
7	EUCTR2017-000725-12-DE (EUCTR)	17/07/2019	28/02/2019	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
8	EUCTR2017-000725-12-GB (EUCTR)	17/04/2019	22/10/2018	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom
9	NCT03706456 (ClinicalTrials.gov)	March 6, 2019	11/10/2018	Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease	A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease	Complex Perianal Fistulas in Adult Patients With Crohn's Disease	Biological: Darvadstrocel	Takeda	NULL	Active, not recruiting	18 Years	N/A	All	22	Phase 3	Japan
10	EUCTR2017-000725-12-IT (EUCTR)	08/01/2018	09/11/2020	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. - -	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: [Cx601]	TIGENIX S.A.U	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	326	Phase 3	United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2017-000725-12-FR (EUCTR)	16/11/2017	25/11/2019	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	326	Phase 3	United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
12	NCT03279081 (ClinicalTrials.gov)	September 15, 2017	21/7/2017	Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)	A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks	Crohn's Disease	Drug: Cx601;Other: Placebo	Tigenix S.A.U.	NULL	Recruiting	18 Years	N/A	All	554	Phase 3	United States;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;United Kingdom
13	EUCTR2017-000725-12-BE (EUCTR)	12/09/2017	01/06/2017	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Israel;Germany;United Kingdom;Italy
14	EUCTR2017-000725-12-HU (EUCTR)	07/09/2017	10/07/2017	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
15	EUCTR2017-000725-12-PL (EUCTR)	03/09/2017	28/07/2017	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	United States;France;Hungary;Czech Republic;Canada;Spain;Belgium;Poland;Israel;Germany;United Kingdom;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2017-000725-12-CZ (EUCTR)	08/08/2017	26/04/2017	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
17	EUCTR2017-000725-12-ES (EUCTR)	26/07/2017	06/06/2017	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue Product Code: Cx601 INN or Proposed INN: To be determined Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	326	Phase 3	United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
18	EUCTR2011-006064-43-DE (EUCTR)	27/09/2012	17/02/2012	Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.	A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study.	Perianal fistulising Crohn´s disease MedDRA version: 17.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601 Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix S.A.U.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy
19	EUCTR2011-006064-43-IT (EUCTR)	13/09/2012	05/03/2012	Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease	A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks. ADMIRE-CD study. - ADIMIRE-CD study	Perianal fistulising Crohn's disease MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601 Product Code: Cx601 INN or Proposed INN: NA Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs)	CELLERIX S.A.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy
20	EUCTR2011-006064-43-NL (EUCTR)	03/07/2012	05/07/2012	Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease.	A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 52 weeks. ADMIRE-CD study. - ADMIRE-CD study	Perianal fistulising Crohn´s disease MedDRA version: 16.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Allogenic eASCs 5 million/ml suspension for injection. Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A. Unipersonal	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	208	Phase 3	France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2011-006064-43-BE (EUCTR)	22/06/2012	21/02/2012	Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.	A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study.	Perianal fistulising Crohn´s desease MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Allogenic eASCs 5 million/ml suspension for injection. Product Code: Cx601 INN or Proposed INN: N/A Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A. Unipersonal	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy
22	EUCTR2011-006064-43-AT (EUCTR)	15/05/2012	05/03/2012	Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.	A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study.	Perianal fistulising Crohn´s disease MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601 Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy
23	NCT01372969 (ClinicalTrials.gov)	June 2009	30/8/2010	Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.	Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.	Crohn's Disease;Anal Fistula	Drug: Cx601	Tigenix S.A.U.	NULL	Completed	18 Years	N/A	All	24	Phase 1;Phase 2	Spain
24	EUCTR2019-000333-39-FR (EUCTR)		04/10/2019	Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
25	EUCTR2020-003193-48-NL (EUCTR)		21/11/2020	A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease.	A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease.	Complex Perianal Fistulas in Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Darvadstrocel Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	Takeda Development Center Americas, Inc.	NULL	NA			Female: yes Male: yes	20	Phase 3	Spain;Poland;Israel;Netherlands;Japan;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002491-10-AT
(EUCTR)

19/08/2020

11/05/2020

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czech Republic;Spain;Austria;Germany;United Kingdom

EUCTR2017-002491-10-FR
(EUCTR)

17/07/2020

09/03/2020

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czech Republic;Spain;Austria;Germany;United Kingdom

EUCTR2017-002491-10-DE
(EUCTR)

22/06/2020

09/03/2020

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom

EUCTR2019-000333-39-BE
(EUCTR)

04/05/2020

21/01/2020

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistula

A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

EUCTR2017-002491-10-CZ
(EUCTR)

10/03/2020

27/11/2019

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czech Republic;Spain;Austria;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000333-39-CZ
(EUCTR)

15/10/2019

03/09/2019

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

EUCTR2017-000725-12-DE
(EUCTR)

17/07/2019

28/02/2019

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.

Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

EUCTR2017-000725-12-GB
(EUCTR)

17/04/2019

22/10/2018

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom

NCT03706456
(ClinicalTrials.gov)

March 6, 2019

11/10/2018

Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease

A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease

Complex Perianal Fistulas in Adult Patients With Crohn's Disease

Biological: Darvadstrocel

Takeda

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

Japan

EUCTR2017-000725-12-IT
(EUCTR)

08/01/2018

09/11/2020

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: [Cx601]

TIGENIX S.A.U

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

326

Phase 3

United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000725-12-FR
(EUCTR)

16/11/2017

25/11/2019

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

326

Phase 3

United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy

NCT03279081
(ClinicalTrials.gov)

September 15, 2017

21/7/2017

Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)

A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks

Crohn's Disease

Drug: Cx601;Other: Placebo

Tigenix S.A.U.

NULL

Recruiting

18 Years

N/A

All

554

Phase 3

United States;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;United Kingdom

EUCTR2017-000725-12-BE
(EUCTR)

12/09/2017

01/06/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Israel;Germany;United Kingdom;Italy

EUCTR2017-000725-12-HU
(EUCTR)

07/09/2017

10/07/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy

EUCTR2017-000725-12-PL
(EUCTR)

03/09/2017

28/07/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Belgium;Poland;Israel;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000725-12-CZ
(EUCTR)

08/08/2017

26/04/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

EUCTR2017-000725-12-ES
(EUCTR)

26/07/2017

06/06/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Product Name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue
Product Code: Cx601
INN or Proposed INN: To be determined
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

326

Phase 3

United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy

EUCTR2011-006064-43-DE
(EUCTR)

27/09/2012

17/02/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.

A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study.

Perianal fistulising Crohn´s disease
MedDRA version: 17.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix S.A.U.

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy

EUCTR2011-006064-43-IT
(EUCTR)

13/09/2012

05/03/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease

A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks. ADMIRE-CD study. - ADIMIRE-CD study

Perianal fistulising Crohn's disease
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601
Product Code: Cx601
INN or Proposed INN: NA
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs)

CELLERIX S.A.

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy

EUCTR2011-006064-43-NL
(EUCTR)

03/07/2012

05/07/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease.

A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 52 weeks. ADMIRE-CD study. - ADMIRE-CD study

Perianal fistulising Crohn´s disease
MedDRA version: 16.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A. Unipersonal

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

208

Phase 3

France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-006064-43-BE
(EUCTR)

22/06/2012

21/02/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.

A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study.

Perianal fistulising Crohn´s desease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: N/A
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A. Unipersonal

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy

EUCTR2011-006064-43-AT
(EUCTR)

15/05/2012

05/03/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.

Perianal fistulising Crohn´s disease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TiGenix, S.A.U.

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy

NCT01372969
(ClinicalTrials.gov)

June 2009

30/8/2010

Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.

Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.

Crohn's Disease;Anal Fistula

Drug: Cx601

Tigenix S.A.U.

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

Spain

EUCTR2019-000333-39-FR
(EUCTR)

04/10/2019

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

EUCTR2020-003193-48-NL
(EUCTR)

21/11/2020

A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease.

A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease.

Complex Perianal Fistulas in Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Alofisel
Product Name: Darvadstrocel
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

Takeda Development Center Americas, Inc.

NULL

Female: yes
Male: yes

Phase 3

Spain;Poland;Israel;Netherlands;Japan;Italy