36. 表皮水疱症 Epidermolysis bullosa Clinical trials / Disease details
臨床試験数 : 163 / 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
| 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 | NCT05464381 (ClinicalTrials.gov) | February 1, 2023 | 5/7/2022 | Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over) | A Double-blind, Randomized, Placebo-controlled, Interventional, Multicenter, Phase III Clinical Trial to Investigate the Safety and Efficacy of ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs) on Epidermolysis Bullosa (EB) | Epidermolysis Bullosa | Drug: allo-APZ2-OTS;Drug: Placebo | RHEACELL GmbH & Co. KG | NULL | Recruiting | N/A | N/A | All | 74 | Phase 3 | Austria |
| 2 | EUCTR2020-002936-55-CZ (EUCTR) | 11/08/2021 | 03/08/2020 | Safety and Efficacy of Mesenchymal Stromal Cells Derived from Adipose Tissue of Non-related Donors in Patients with The Butterfly Disease: Clinical Trial Phase I/II | Safety and Efficacy of Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells in Patients with Epidermolysis Bullosa: Clinical Trial Phase I/II - MSC-EB | Epidermolysis bullosa congenita;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: allogeneic adipose tissue-derived MSC INN or Proposed INN: Human allogeneic adipose tissue-derived mesenchymal stem cells expanded Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED | Masarykova univerzita | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 1;Phase 2 | Czech Republic | ||
| 3 | EUCTR2018-003890-91-PL (EUCTR) | 29/09/2020 | 13/11/2018 | Treatment of wound in the course of Epidermolysis Bullosa, chronic venous leg ulceration and thermal injury by biological dressing made of mesynchemal stem cells seeded on acellular human skin. | The development of innovative advanced therapy medicinal product (biological dressing of the human race) in the treatment of Epidermolysis Bullosa (EB) and other chronic wounds. | BIOOPA dressing will be used in the treatment of wounds in the course of Epidermolysis Bullosa, chronic venous leg ulceration and thermal injury (second degree burn). MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: BIOOPA dressing INN or Proposed INN: Human Allogeneic WJ-MSCs Other descriptive name: WHARTON’S JELLY DERIVED MESENCHYMAL STEM CELLS | Medical University of Warsaw | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 1;Phase 2 | Poland | ||
| 4 | JPRN-UMIN000028366 | 2017/06/21 | 25/07/2017 | A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients. | A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients. - A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients. | dystrophic epidermolysis bullosa | ISN001, the sheet containing allogenic adipose derived mesenchymal stromal cells (1000000/sheet), is applied to the lesion(s) once a week up to 8 times | Ishin Pharmaceutical Co. Ltd. | NULL | Complete: follow-up complete | 6years-old | 70years-old | Male and Female | 5 | Phase 1,2 | Japan |
| 5 | NCT02323789 (ClinicalTrials.gov) | June 2015 | 18/12/2014 | Mesenchymal Stromal Cells in Adults With Recessive Dystrophic Epidermolysis Bullosa | A Phase I/II Study Evaluating Allogeneic Mesenchymal Stromal Cells in Adults With Recessive Dystrophic Epidermolysis Bullosa | Recessive Dystrophic Epidermolysis Bullosa | Drug: Mesenchymal stromal cells | King's College London | NULL | Active, not recruiting | 18 Years | 65 Years | All | 10 | Phase 1/Phase 2 | United Kingdom |
| 6 | EUCTR2014-004500-30-GB (EUCTR) | 13/02/2015 | 22/12/2014 | A prospective phase I/II study to evaluate the use of mesenchymal stromal (stem) cells for the treatment of skin disease in adults with recessive dystrophic epidermolysis bullosa | A phase I/II study evaluating allogeneic mesenchymal stromal cells in adults with recessive dystrophic epidermolysis bullosa - ADSTEM | Recessive dystrophic epidermolysis bullosa;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Allogeneic mesenchymal stromal cells Product Code: TC-MSC | King's College London | Guy's and St Thomas NHS Foundation Trust | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 7 | EUCTR2012-000605-72-NL (EUCTR) | 06/02/2014 | 12/08/2013 | Stem cell transplantation with cord blood and mesenchymal stem cells after reduced intensity conditioning for severe forms of the blistering disease epidermolysis bullosa | Unrelated cord blood transplantation after reduced toxicity conditioning with mesenchymal stromal cell co-infusion in patients with severe epidermolysis bullosa - CB+MSCforEB | The source population consists of patients referred to or within the UMC Groningen because they have diagnosed clinically and genetically severe generalized RDEB.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: TC-MSC INN or Proposed INN: Mesenchymal stromal cells Trade Name: Busilvex Trade Name: Fludarabine Product Name: FLudarabine Trade Name: THYMOGLOBULINE Product Name: Thymoglobuline | Universitair Medisch Centrum Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 11 | Phase 2 | Netherlands | ||
| 8 | EUCTR2012-001394-87-GB (EUCTR) | 16/11/2012 | 22/08/2012 | A prospective phase I/II study to evaluate allogeneic mesenchymal stromal cells for the treatment of skin disease in children with recessive dystrophic epidermolysis bullosa. | A prospective phase I/II study to evaluate allogeneic mesenchymal stromal cells for the treatment of skin disease in children with recessive dystrophic epidermolysis bullosa. - EBSTEM | Recessive Dystrophic Epidermolysis Bullosa MedDRA version: 17.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Allogenic mesenchymal stromal cells Product Code: TC-MSC | King's College London | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1;Phase 2 | United Kingdom |