EBGraft
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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
3
1 country
1
Study Start
January 10, 2020
Actual (reported)Primary Completion
June 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This phase I/II clinical trial aims to treat 3 adult subjects with Recessive Dystrophic Epidermolysis Bullosa, expressing residual C7 levels, by genetically corrected autologous skin equivalent grafts on selected areas (up to 300 cm2).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2019
Actual (reported)December 5, 2019
Actual (reported)January 10, 2020
Actual (reported)June 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety of grafting SIN RV-mediated COL7A1 gene-modified autologous skin equivalent: Adverse Events (AE), Serious Adverse Events (SAEs), Adverse Reactions (ARs) and Serious Adverse Reactions (SARs)
The primary objective is to evaluate the safety of autologous autologous skin equivalent grafts genetically corrected with a SIN COL7A1 retroviral vector (RV) in adults with RDEB Primary Endpoints: Record of Adverse Events (AE), Serious Adverse Events (SAEs), Adverse Reactions (ARs) and Serious Adverse Reactions (SARs).
Month 12 post grafting.
Change in C7 protein expression
Month 1, Month 3, Month 6, Month 12 post grafting.
Change in anchoring fibrils number
Month 1, Month 3, Month 6, Month 12 post grafting.
Change in scar quality: Vancouver Scar Scale (VSS)
Month 1, Month 2, Month 3, Month 6, Month 12 post grafting.
Changes in blister number over the grafted skin
Month 1, Month 2, Month 3, Month 6, Month 12 post grafting.
Changes in clinical appearance of grafted skin
Month 1, Month 2, Month 3, Month 6, Month 12 post grafting.
Graft of SIN RV-mediated COL7A1 gene-modified autologous skin equivalent
Graft of SIN RV-mediated COL7A1 gene-modified autologous skin equivalent
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institut Imagine Necker Hospital
Paris, 75743, France
Gaucher S, Lwin SM, Titeux M, Abdul-Wahab A, Pironon N, Izmiryan A, Miskinyte S, Ganier C, Duchatelet S, Mellerio JE, Bourrat E, McGrath JA, Hovnanian A. EBGene trial: patient preselection outcomes for the European GENEGRAFT ex vivo phase I/II gene therapy trial for recessive dystrophic epidermolysis bullosa. Br J Dermatol. 2020 Mar;182(3):794-797. doi: 10.1111/bjd.18559. Epub 2019 Nov 27. No abstract available.
Titeux M, Pendaries V, Zanta-Boussif MA, Decha A, Pironon N, Tonasso L, Mejia JE, Brice A, Danos O, Hovnanian A. SIN retroviral vectors expressing COL7A1 under human promoters for ex vivo gene therapy of recessive dystrophic epidermolysis bullosa. Mol Ther. 2010 Aug;18(8):1509-18. doi: 10.1038/mt.2010.91. Epub 2010 May 18.
First Submitted
November 25, 2019
First Posted
December 5, 2019
Study Start
January 10, 2020
Actual (reported)Primary Completion
June 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hennig K, Raasch L, Kolbe C, Weidner S, Leisegang M, Uckert W, Titeux M, Hovnanian A, Kuehlcke K, Loew R. HEK293-based production platform for gamma-retroviral (self-inactivating) vectors: application for safe and efficient transfer of COL7A1 cDNA. Hum Gene Ther Clin Dev. 2014 Dec;25(4):218-28. doi: 10.1089/humc.2014.083.
Study Completion
June 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 12, 2026
Record last verified: 2026-02
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