Clinical Trial

Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds

Not Yet Recruiting Phase 4
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Summary
The Master Protocol includes 3 studies (Study A, Study B, and Study C) that will evaluate pz-cel and related processes in the post-marketing setting. Study A investigates the efficacy and safety of non-conforming pz-cel in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). Study B enables the collection of additional biopsy samples from patients receiving treatment with pz-cel. Study C assesses the efficacy and safety of pz-cel in patient populations not represented in the VIITAL clinical trial (NCT04227106).
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-08-07
Trial Details
NCT Number NCT07717736
Lead Sponsor Abeona Therapeutics, Inc
Conditions Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB), Dystrophic Epidermolysis Bullosa (DEB)
Enrollment 100 participants
Start Date 2026-11
Primary Completion 2031-11 (estimated)
Study Completion 2032-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-06