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

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02810951
(ClinicalTrials.gov)
July 1, 201613/6/2016A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)A Phase I/II Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB)Epidermolysis Bullosa Dystrophica, RecessiveGenetic: FCX-007Castle Creek Biosciences, LLC.NULLTerminated7 YearsN/AAll6Phase 1/Phase 2United States
2EUCTR2014-004884-19-GB
(EUCTR)
24/05/201618/02/2015Gene Therapy Trial in adults with Inherited Blistering Skin DiseasePhase 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 LondonGuy's and St Thomas' NHS Foundation TrustNot RecruitingFemale: yes
Male: yes
10Phase 1United Kingdom
3NCT02493816
(ClinicalTrials.gov)
September 201521/5/2015Safety Study of Gene-modified Autologous Fibroblasts in Recessive Dystrophic Epidermolysis BullosaPhase I Study of Lentiviral-mediated COL7A1 Gene-modified Autologous Fibroblasts in Adults With Recessive Dystrophic Epidermolysis Bullosa.Recessive Dystrophic Epidermolysis BullosaDrug: Gene-modified autologous fibroblastsKing's College LondonUniversity College, LondonCompleted17 YearsN/AAll5Phase 1United Kingdom
4EUCTR2012-001815-21-PT
(EUCTR)
07/06/201328/03/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
26France;United States;Portugal;Canada;Spain;Poland;Austria;Germany
5EUCTR2012-001815-21-DE
(EUCTR)
22/05/201301/11/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
26Portugal;United States;Spain;Austria;Australia;Germany
6EUCTR2012-001815-21-AT
(EUCTR)
24/01/201325/01/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
26United States;Portugal;France;Canada;Spain;Poland;Austria;Germany
7EUCTR2012-001815-21-ES
(EUCTR)
18/01/201326/09/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
25Portugal;United States;Spain;Austria;Australia;Germany
8EUCTR2010-023121-38-GB
(EUCTR)
13/01/201126/11/2010A 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 trialA 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 bullosaTrade Name: ICX-RHY-013
Product Name: Cultured allogeneic fibroblasts
Product Code: ICX-RHY-013
INN or Proposed INN: Fibroblasts
Intercytex LtdNULLNot RecruitingFemale: yes
Male: yes
25Phase 2United Kingdom