36. Epidermolysis bullosa Clinical trials / Disease details
Clinical trials : 160 / Drugs : 195 - (DrugBank : 47) / Drug target genes : 50 - Drug target pathways : 124
| 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 | NCT04213261 (ClinicalTrials.gov) | June 9, 2020 | 2/12/2019 | A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa | A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa | Recessive Dystrophic Epidermolysis Bullosa | Biological: FCX-007 (dabocemagene autoficel; see below for FCX-007 description) | Castle Creek Biosciences, LLC. | NULL | Recruiting | 2 Years | N/A | All | 24 | Phase 3 | United States |
| 2 | EUCTR2014-004884-19-GB (EUCTR) | 24/05/2016 | 18/02/2015 | Gene Therapy Trial in adults with Inherited Blistering Skin Disease | Phase I study of lentiviral-mediated COL7A1 gene-modified autologous fibroblasts in adults with recessive dystrophic epidermolysis bullosa (RDEB) - LENTICOL-F | Recessive Dystrophic Epidermolysis Bullosa MedDRA version: 18.1;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: SIN LV Mediated ex vivo transduced autologous fibroblasts expressing codon-optimised COL7A1 Product Code: Not applicable | King's College London | Guy's and St Thomas' NHS Foundation Trust | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | United Kingdom | ||
| 3 | NCT02493816 (ClinicalTrials.gov) | September 2015 | 21/5/2015 | Safety Study of Gene-modified Autologous Fibroblasts in Recessive Dystrophic Epidermolysis Bullosa | Phase I Study of Lentiviral-mediated COL7A1 Gene-modified Autologous Fibroblasts in Adults With Recessive Dystrophic Epidermolysis Bullosa. | Recessive Dystrophic Epidermolysis Bullosa | Drug: Gene-modified autologous fibroblasts | King's College London | University College, London | Completed | 17 Years | N/A | All | 5 | Phase 1 | United Kingdom |
| 4 | EUCTR2012-001815-21-PT (EUCTR) | 07/06/2013 | 28/03/2013 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 14.1;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: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 26 | France;United States;Portugal;Canada;Spain;Poland;Austria;Germany | |||
| 5 | EUCTR2012-001815-21-DE (EUCTR) | 22/05/2013 | 01/11/2012 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 14.1;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: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 26 | Portugal;United States;Spain;Austria;Australia;Germany | |||
| 6 | EUCTR2012-001815-21-AT (EUCTR) | 24/01/2013 | 25/01/2013 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 16.0;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: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 26 | United States;Portugal;France;Canada;Spain;Poland;Austria;Germany | |||
| 7 | EUCTR2012-001815-21-ES (EUCTR) | 18/01/2013 | 26/09/2012 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 15.0;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: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Portugal;United States;Spain;Austria;Australia;Germany | |||
| 8 | EUCTR2010-023121-38-GB (EUCTR) | 13/01/2011 | 26/11/2010 | A prospective placebo controlled phase II study to evaluate the use of allogeneic fibroblasts for the treatment of skin erosions in recessive dystrophic epidermolysis bulllosa. - Fibroblast cell therapy for RDEB - a phase II clinical trial | A prospective placebo controlled phase II study to evaluate the use of allogeneic fibroblasts for the treatment of skin erosions in recessive dystrophic epidermolysis bulllosa. - Fibroblast cell therapy for RDEB - a phase II clinical trial | Recessive dystropic epidermolysis bullosa | Trade Name: ICX-RHY-013 Product Name: Cultured allogeneic fibroblasts Product Code: ICX-RHY-013 INN or Proposed INN: Fibroblasts | Intercytex Ltd | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | United Kingdom |