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Clinical trials for Recessive dystrophic epidermolysis bullosa

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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    17 result(s) found for: Recessive dystrophic epidermolysis bullosa. Displaying page 1 of 1.
    EudraCT Number: 2014-005679-96 Sponsor Protocol Number: SD-006 Start Date*: 2015-03-16
    Sponsor Name:Scioderm, INC
    Full Title: An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa
    Medical condition: Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) NL (Completed) GB (Prematurely Ended) DE (Prematurely Ended) PL (Prematurely Ended) ES (Prematurely Ended) LT (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002288-14 Sponsor Protocol Number: SD-005 Start Date*: 2014-08-08
    Sponsor Name:Scioderm, An Amicus Therapeutics Company
    Full Title: A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa
    Medical condition: Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) NL (Completed) GB (Completed) IT (Completed) DE (Completed) PL (Completed) ES (Completed) LT (Completed) BE (Ongoing)
    Trial results: View results
    EudraCT Number: 2023-000283-62 Sponsor Protocol Number: KB103-001 Start Date*: 2023-03-21
    Sponsor Name:Krystal Biotech
    Full Title: A Phase I/II Study of KB103, a Non-Integrating, Replication-Incompetent HSV Vector Expressing the Human Collagen VII Protein, for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)
    Medical condition: Dystrophic Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2014-004884-19 Sponsor Protocol Number: LENTICOL-F Start Date*: 2016-05-24
    Sponsor Name:King's College London [...]
    1. King's College London
    2. Guy's and St Thomas' NHS Foundation Trust
    Full Title: Phase I study of lentiviral-mediated COL7A1 gene-modified autologous fibroblasts in adults with recessive dystrophic epidermolysis bullosa (RDEB)
    Medical condition: Recessive Dystrophic Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-003890-91 Sponsor Protocol Number: BIOOPA Start Date*: 2020-09-29
    Sponsor Name:Medical University of Warsaw
    Full Title: 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.
    Medical condition: 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).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004806-17 Sponsor Protocol Number: PQ-313-002 Start Date*: 2018-05-18
    Sponsor Name:Wings Therapeutics Inc.
    Full Title: A first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subj...
    Medical condition: Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) DE (Prematurely Ended) CZ (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001009-98 Sponsor Protocol Number: allo-APZ2-EB-II-01 Start Date*: 2019-03-01
    Sponsor Name:RHEACELL GmbH & Co. KG
    Full Title: An interventional, multicenter, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-EB on epidermolysis bullosa (EB)
    Medical condition: Recessive dystrophic epidermolysis bullosa (RDEB)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-023121-38 Sponsor Protocol Number: ICX-DEBRHY-2 Start Date*: 2011-01-13
    Sponsor Name:Intercytex Ltd
    Full Title: 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.
    Medical condition: Recessive dystropic epidermolysis bullosa
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003670-32 Sponsor Protocol Number: REFLECT Start Date*: Information not available in EudraCT
    Sponsor Name:Medical Center - University of Freiburg
    Full Title: A dual-center prospective phase I/II trial to establish safety, tolerability and to obtain first data on efficacy of losartan in children with recessive dystrophic epidermolysis bullosa (RDEB)
    Medical condition: Recessive dystrophic epidermolysis bullosa (RDEB)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000606-37 Sponsor Protocol Number: MesenSistem-EB Start Date*: 2017-11-16
    Sponsor Name:Fundación para la Investigación Biomédica Hospital Universitario La Paz
    Full Title: Safety and preliminary efficacy study of infusing mesenchymal stem cells derived from bone marrow for treating Recessive Dystrophic Epidermolysis Bullosa.
    Medical condition: Recessive Dystrophic Epidermolysis Bullosa
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001394-87 Sponsor Protocol Number: EBSTEM001 Start Date*: 2012-11-16
    Sponsor Name:King's College London
    Full Title: 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.
    Medical condition: Recessive Dystrophic Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-004592-74 Sponsor Protocol Number: HOLOGENE7(HTA-HG7-01) Start Date*: 2016-06-01
    Sponsor Name:Holostem Terapie Avanzate s.r.l.
    Full Title: PROSPECTIVE, OPEN LABEL, UNCONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF AUTOLOGOUS CULTURED EPIDERMAL GRAFTS CONTAINING EPIDERMAL STEM CELLS GENETICALLY MODIFIED WITH A GAMMA-RETR...
    Medical condition: RDEB is characterized by generalized skin blistering, erosions, crusts, atrophic scarring, onychodystrophy and loss of nails, mutilating pseudosyndactyly of hands and feet, as well as oral cavity l...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-004500-30 Sponsor Protocol Number: ADSTEM001 Start Date*: 2015-02-13
    Sponsor Name:King's College London [...]
    1. King's College London
    2. Guy's and St Thomas NHS Foundation Trust
    Full Title: A phase I/II study evaluating allogeneic mesenchymal stromal cells in adults with recessive dystrophic epidermolysis bullosa
    Medical condition: Recessive dystrophic epidermolysis bullosa
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002790-35 Sponsor Protocol Number: C12-48 Start Date*: 2019-06-04
    Sponsor Name:INSERM
    Full Title: Phase I/II ex vivo gene therapy clinical trial for RDEB using autologous skin equivalent grafts genetically corrected with a COL7A1-encoding SIN retroviral vector
    Medical condition: The trial aims to treat the recessive dystrophic epidermolysis bullosa (RDEB) by grafting one to three subjects with RDEB with autologous COL7A1-modified skin equivalents, using SIN-RV encoding COL...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10074980 Epidermolysis bullosa aquisita LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000605-72 Sponsor Protocol Number: CB+MSCforEB Start Date*: 2014-02-06
    Sponsor Name:Universitair Medisch Centrum Utrecht
    Full Title: Unrelated cord blood transplantation after reduced toxicity conditioning with mesenchymal stromal cell co-infusion in patients with severe epidermolysis bullosa
    Medical condition: The source population consists of patients referred to or within the UMC Groningen because they have diagnosed clinically and genetically severe generalized RDEB.
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003832-19 Sponsor Protocol Number: RigosertibforRDEB-SCC Start Date*: 2017-12-11
    Sponsor Name:Gemeinn. Salzburger Landeskliniken BetriebsGesmbH, University Hospital for Dermatology, EB-House Austria
    Full Title: A Phase II, Open Study to Assess Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis bullosa associated Locally Advanced/Metastatic Squamous Cell Carcinoma
    Medical condition: Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genodermatose caused by mutations in COL7A1, characterized by generalized skin blistering and involvement of mucous membranes. Aggressi...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000103-20 Sponsor Protocol Number: 202000638 Start Date*: 2021-07-15
    Sponsor Name:University Medical Center Groningen
    Full Title: An explorative randomized, placebo-controlled and double-blind intervention crossover study: Transvamix (100mg/mL THC / 50mg/mL CBD) to treat chronic pain in Epidermolysis Bullosa
    Medical condition: Genetic Epidermolysis Bullosa
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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