DDrare: Database of Drug Development for Rare Diseases

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
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 = 0,5 mg Prevenar i.m.; 0,5 mg seasonal influenza vaccine i.m.; 0.9% sodium chloride; 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID; 1-22460; 10% Nitroglycerine in Propylene Glycol, USP; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; ABR-215757; ACHIM as solute (10^9 intestinal microbes/ml); ACT-064992; ACT-293987; ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADSVF application in the right hand; AIMSPRO; AL; AM-01; ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS; ASASANTIN Retard; ASC; AUC of MPA measure; AVID200; Abatacept; Abituzumab; Abituzumab 1500 mg; Abituzumab 500 mg; Acetaminophen; Acetate; Acetylcysteine; Acetylsalicylic acid; Acotiamide; Adempas; Administration of rituximab and methylprednisolone; Air; Ajulemic acid; Albumin; Alemtuzumab; Alginic acid; Allogeneic Mesenchymal Stem Cells (AlloMSC); Alpha-2C AR antagonist; Alprostadil; Ambrisentan; Amlodipine; Amlodipine Gel; Anaerobically Cultivated Human Intestinal Microbiota; Anaerobically Cultivated medium; Anti-CT51 antigen mAb; Anti-Thymocyte Globulin; Anti-Thymocyte Globulin, Rabbit; Anti-integrin alphaV mAb; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Asasantin Retard ®; Aspirin; Atorvastatin; Autologous ASC; Autologous Stem Cells; Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells; Aviptadil; BAY63-2521; BERMEKIMAB; BH4; BIBF 1120; BMS-986020; BOSENTAN MONOHYDRATE; BOTOX® solution; Beam; Belimumab; Belumosudil (KD025); Bermekimab; Biopsy; Blood coagulation factor XIII; Blood sample; Blood samples; Blood sampling; Bortezomib; Bosentan; Bosentan (Tracleer); Bosentan 125 mg; Bosentan 62.5 mg; Bosentan group; Bosentan monohydrate; Botox; Botulinum Toxin Type B; Botulinum toxin A; Botulinum toxin type B (2500 units / vial); Botulinum toxin(Botox); Bovine type I collagen; Brentuximab; Brentuximab Vedotin; Brentuximab vedotin; Brodalumab; Bupivacaine; Buspirone; Busulfan; Butanoic acid; C-82 Topical Gel, 1%; C21; C225; CAM2043; CAPILLAREMA; CC; CC-4047; CD; CD34 selected autologous hematopoietic cells; CD34+SC; CILOSTAZOL; CYCLOPHOSPHAMIDE; Calcipotriene; Calcium; Calcium Channel Blockers; Campath; Carbon; Carbon dioxide; Cetuximab; Chloride; Cialis; Cilostazol; Clobetasol; Cuprimine (penicillamine); Currently available therapy in the community; Cutaneous iontophoresis of treprostinil; Cyclophosphamide; Cyclophosphamide Injection 1g; DI-17E6; DIGNA P144 CREAM; DIGNA P144 cream; Dabigatran; Dabigatran etexilate; Dasatinib; Depot leuprolide acetate 3.75 mg; Dersimelagon; Device: Air filled balloon catheter; Device: Fractional carbon dioxide laser; Device: Manual toothbrush; Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss); Device: Measurment with Aspirational Medical Device; Device: Measurment with Cutometer MPA 580; Device: Serial night time position splint; Device: Solid state catheter; Device: Sonic toothbrush; Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss); Device: Ultraviolet A1 phototherapy (UVA1); Device: the ozone generator device (Human Pro medic, German); Diagnostic Test: CMRI; Diagnostic Test: Imaging; Diagnostic Test: P-MPA concentration; Diagnostic Test: Pulmonary function test; Diltiazem; Diltiazem Gel 2%; Dimethyl Fumarate (DMF); Dimethyl fumarate; Diphenhydramine; Dipyridamole; Divalproex sodium; Domperidone; Double-Blind Rituximab; Drug treatment; Dupilumab; Dupilumab 300Mg Solution for Injection; EDTA; EMA/CHMP/212874/2015; EMD 525797; ENDOPROST; ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA; ENDOPROST 0,05MG/0,5ML 1F; ENDOPROST 50*INFUS 1F 0,050MG/; EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS; Endoprost; Endothelin receptor blocker; Erbitux; Esbriet; Ethanol; FILGRASTIM; FT011; Factor XIII; Fasudil; Fibrogammin® 1250; Fibrogammin®P, coagulation factor XIII concentrate (Human); Filgrastim; Fludarabine; Fludarabine phosphate; Fresolimumab; From August 2020 'no additional treatment'; G-CSF; G451990; GLIVEC; GLPG1690; GM-CSF; GS-248; GSK2330811; GSK2330811 Solution for Injection, 100mg/ml; Genetic: FCX-013; Glivec; Glivec 100 mg Filmtabletten; Glycyrrhizin; Gran; HIDONAC*EV 1FL 5G 25ML; HUMAN NORMAL IMMUNOGLOBULIN; Hematopoietic stem cell transplantation; High-dose intravenous immunoglobulin (Venoglobulin-IH); Hizentra; Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody; Human normal immunoglobulin; Human normal immunoglobulin for intravenous (IV) administration; Human normal immunoglobulin for intravenous administration; Human normal immunoglobulin for subcutaneous administration; Hyaluronidase; Hyaluronidase injected intradermally; Hyperimmune caprine serum; Hyperoxia; ILOPROST SALE DI TROMETAMOLO; ILOPROST TROMETAMOL; IMATINIB MESILATO; INCB039110; INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS; INTERLEUKIN 2; ITACITINIB; IV Cyclophosphamide; IVA337; IVIg; Ifetroban; IgPro10; IgPro20; Iguratimod; Ilomedin; Iloprost; Iloprost Injection, for intravenous use; Iloprost low dose; Iloprost therapy up to 2 ng/kg x min; Iloprost trometamol; Imatinib; Imatinib Mesylate; Imatinib mesylate; Imiquimod; Imiquimod 5% cream; Imnovid; Imnovid 1 mg hard capsules; Indocyanine Green; Indocyanine green; Indole; Influenza vaccine; Injection of autologous stromal vascular fraction; Interleukin 2; Intravenous immunoglobulin; Iontophoresis of treprostinil; Itacitinib; JBT-101; KHK4827; LANIFIBRANOR; LENABASUM; Lactobacillus; Lanifibranor; Lenabasum; Lenabasum 20 mg; Lenabasum 20 mg Powder in Capsule; Lenabasum 5 mg; Lenabasum 5 mg Powder in Capsule; Leuprolide; Lidocaine; Lidocaine 2% without vessel constrictor; Lipitor; Liposomal bupivacaine; MABp1 (Bermekimab); MEDI-546; MEDI-551; MESNA; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM SUCCINATE; METOCLOPRAMIDE; METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL; MHSCT; MMF; MPA; MQX-503; MSC; MT-7117; MabThera; Mabthera; Macitentan; Macitentan 10 mg; Macitentan 10mg; Macitentan 3 mg; Macitentan 3mg; Medrone; Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jelly; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesenchymal stromal cells; Mesna; Methotrexate; Methylprednisolon; Methylprednisolone; Methylprednisolone acetate; Metoclopramide; Metronidazole; Mg; Microgynon; Mizoribine; Mycophenolate; Mycophenolate Mofetil; Mycophenolate Mofetil (MMF); Mycophenolate mofetil; Mycophenolic Acid; Mycophenolic acid; N-acetylcysteine (NAC); NAC; ND; NINTEDANIB; NON PROPIETRY, THEREFORE N/A; Neovasculgen; Neupogen; Nilotinib; Nilotinib (Tasigna); Nintedanib; Nitroglycerin; Nitroglycerin Ointment 2%; Nitroglycerine; Nitroglycerine gel; Nitroprusside; Nivolumab; Non applicabile; Null; ORENCIA; ORM-12471; ORM-12471 30mg; ORM-12741; Ofev; Omeprazole; Omeprazole 20mg; Onabotulinumtoxin A; Ophthalmic Emulsion; Opsumit 10 Mg Tablet; Oral Ifetroban; Oral bovine type I collagen; Oral treprostinil; Orencia; Other vasodilator; Other: Biopsy; Other: Bronchoalveolar samples; Other: Laboratory Biomarker Analysis; Other: Physalis angulata ethanol extract; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Rosemary essential oil; Other: Vasculopathy assessment; Other: flow cytometry; Other: laboratory biomarker analysis; Other: sodium chloride; Ozone; P144; P144 Cytokine Inhibitor; P144 Cytokines Inhibitors; P144 DIGNA CREAM; P144 cream; P144. Cytokines Inhibitors; PFD; PIRFENIDONE; PLETAL; PR1; PRUCALOPRIDE SUCCINATE; Paquinimod; Part B Open-Label Extension; Patients will be randomized to receive EHP-101; Penicillamine; Peripheral Blood Stem Cells; Phosphate; Phosphodiesterase Inhibitors; Physiological saline; Pirfenidone; Pirfenidone (PFD); Placebo; Platelet Gel; Plerixafor; Pletal; Polydeoxyribonucleotides; Pomalidomida; Pomalidomide; Pomalidomide (CC-4047); Prednisolon; Prednisolona; Prednisolone; Prednisolone 5 mg; Prednisolone 5mg Gastro-resistant Tablets; Prednisolone and taper; Prednisoloni; Prednisolonum; Prednisone; Prednizolon; Prednizolonas; Privigen; Procedure: 2 ml of whole blood sample will be collected on EDTA tube; Procedure: Adipose tissue harvest; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Leukapheresis; Procedure: Leukopheresis; Procedure: Order of two elements of surgical procedure; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: Self bone marrow transplant; Procedure: Total Body Irradiation; Procedure: Total-Body Irradiation; Procedure: biopsy; Procedure: bone marrow transplantation; Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Procedure: quality-of-life assessment; Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation; Procedure: stem cell transplantation; Propylene glycol; Prostanoids; Prucalopride; QAX576; RATG; RESOLOR*28CPR RIV 2MG; RIOCIGUAT; RO487-7533/F10-04; Rabbit; Rabeprazole; Radiation: Cone Beam Computed Tomography (CBCT); Radiation: Intensity-Modulated Radiation Therapy; Radiation: Total Body Irradiation; Radiation: total-body irradiation; Rapamycin; RbATG; Recombinant humanized anti-human monoclonal antibody directed against the IL-6R; Relaxin; Resolor; Resunab, ajulemic acid, anabasum; Rilonacept; Ringer lactate; Riocigu; Riociguat; Riociguat (Adempas, BAY63-2521); Riociguat coated tablet 0.5 mg; Riociguat coated tablet 1.0 mg; Riociguat coated tablet 1.5 mg; Riociguat coated tablet 2.0 mg; Riociguat coated tablet 2.5 m; Riociguat coated tablet 2.5 mg; Rituximab; Ro 47-0203; Ro 487-7533/F10-04; Ro47-0203 / ACT-050088; RoActemra; RoActemra 162 mg; Rosemary; Rosuvastatin; SAR100842; SAR156597; SAR156597 (ACT14604); SAR231893; SELEXIPAG; SINVACOR*28CPR RIV 20MG; SODIUM NITROPRUSSIDE; SODIUM THIOSULFATE PENTAHYDRATE; STI571; STS; Saccharomyces; Saccharomyces Boulardii Oral Tablet; Selexipag; Sildenafil; Sildenafil 20mg; Sildenafil 20mg and Bosentan 62.5mg; Sildenafil citrate; Sildenafil therapy; Simvastatin; Sinvacor; Sirolimus; Sodium Thiosulfate 10%; Sodium chloride; Sodium fluoride; Sodium fluoride 18F; Sodium thiosulfate; Sodium thiosulfate 10%; Solu-Medrol; Solu-Medrone; Solu-medrol; Solu-medrone; Soluble Ve cadherin; Standard of care; Sterile saline solution; Steroids; Stromal Vascular fraction; Study of the gene expression profile; TEPEZZA; TERGURIDE HYDROGENMALEATE; TOCILIZUMAB; TRACLEER*125MG 56CPR RIV.; TRACLEER*56CPR RIV 125MG; TREPROSTINIL SODIUM; Tacrolimus; Tadalafil; Tadalafil and ambrisentan upfront combination therapy; Tepezza; Terguride; Thalidomide; Thiotepa; Thymoglobulin; Thymoglobuline; Tocilizumab; Tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS); Tocilizumab [RoActemra/Actemra]; Tofacitinib; Topical AmphiMatrix; Topical AmphiMatrix with nitroglycerin (MQX-503); Topical calcipotriene 0.005% ointment; Topical organogel with nitroglycerin; Tracleer; Transdihydrolisuride; Treprostinil; Treprostinil Sodium; Treprostinil diethanolamine; Trimebutine; Trometamol; UCMSC; UT-15 SR; UT-15C SR; UT-15C-SR; Urine sample; VIB7734; VIP; Vaseline; Veledimex; Vessel; Vivomixx probiotics; Volibris; Water; Yellow Fever Vaccine; Yellow Fever vaccine (17D); ZD4054; Zibotentan; Ziritaxestat

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	NCT03593902 (ClinicalTrials.gov)	May 17, 2018	28/6/2018	Cardiac Safe Transplants for Systemic Sclerosis	Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction	Systemic Sclerosis;Scleroderma	Drug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells	Northwestern University	NULL	Terminated	18 Years	65 Years	All	9	Phase 2;Phase 3	United States
2	NCT01445821 (ClinicalTrials.gov)	September 15, 2011	29/9/2011	Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial	Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb)	Scleroderma, Systemic	Biological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: Fludarabine	Northwestern University	NULL	Terminated	17 Years	60 Years	All	44	Phase 3	United States
3	NCT01047072 (ClinicalTrials.gov)	January 2010	11/1/2010	Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis	Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis	Systemic Scleroderma	Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	National Cancer Institute (NCI)	Withdrawn	18 Years	65 Years	Both	0	Phase 2	United States
4	NCT00684255 (ClinicalTrials.gov)	August 2007	22/5/2008	Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)	Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)	Systemic Lupus Erythematosus;Systemic Sclerosis	Procedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: Campath	New York Medical College	NULL	Terminated	7 Years	50 Years	All	1	Phase 1	United States
5	NCT00622895 (ClinicalTrials.gov)	September 1, 2006	22/2/2008	Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis	Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis	Systemic Scleroderma;Severe Systemic Sclerosis	Drug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsy	Fred Hutchinson Cancer Research Center	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	N/A	70 Years	All	3	Phase 1;Phase 2	United States
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	NCT00040651 (ClinicalTrials.gov)	July 2002	5/7/2002	Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients	Transplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation Study	Scleroderma;Systemic Sclerosis	Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Thymoglobulin;Procedure: Leukapheresis;Procedure: Self bone marrow transplant	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	University of Pittsburgh;Amgen;Genzyme, a Sanofi Company	Terminated	18 Years	70 Years	Both	15	Phase 1	United States

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

NCT03593902
(ClinicalTrials.gov)

May 17, 2018

28/6/2018

Cardiac Safe Transplants for Systemic Sclerosis

Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction

Systemic Sclerosis;Scleroderma

Drug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells

Northwestern University

NULL

Terminated

18 Years

65 Years

All

Phase 2;Phase 3

United States

NCT01445821
(ClinicalTrials.gov)

September 15, 2011

29/9/2011

Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial

Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb)

Scleroderma, Systemic

Biological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: Fludarabine

Northwestern University

NULL

Terminated

17 Years

60 Years

All

Phase 3

United States

NCT01047072
(ClinicalTrials.gov)

January 2010

11/1/2010

Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis

Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis

Systemic Scleroderma

Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

National Cancer Institute (NCI)

Withdrawn

18 Years

65 Years

Both

Phase 2

United States

NCT00684255
(ClinicalTrials.gov)

August 2007

22/5/2008

Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)

Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)

Systemic Lupus Erythematosus;Systemic Sclerosis

Procedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: Campath

New York Medical College

NULL

Terminated

7 Years

50 Years

All

Phase 1

United States

NCT00622895
(ClinicalTrials.gov)

September 1, 2006

22/2/2008

Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis

Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis

Systemic Scleroderma;Severe Systemic Sclerosis

Drug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsy

Fred Hutchinson Cancer Research Center

National Institute of Allergy and Infectious Diseases (NIAID)

Completed

N/A

70 Years

All

Phase 1;Phase 2

United States

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

NCT00040651
(ClinicalTrials.gov)

July 2002

5/7/2002

Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients

Transplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation Study

Scleroderma;Systemic Sclerosis

Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Thymoglobulin;Procedure: Leukapheresis;Procedure: Self bone marrow transplant

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

University of Pittsburgh;Amgen;Genzyme, a Sanofi Company

Terminated

18 Years

70 Years

Both

Phase 1

United States