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

NCT07717736 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-06

No results posted yet for this study

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).

Conditions

  • Epidermolysis Bullosa (EB)
  • Recessive Dystrophic Epidermolysis Bullosa (RDEB)
  • Dystrophic Epidermolysis Bullosa (DEB)

Interventions

BIOLOGICAL

Non-conforming pz-cel surgical application to RDEB wounds

Non-conforming pz-cel is pz-cel intended for commercial treatment that did not meet commercial release criteria, but had no safety concerns associated with its use.

PROCEDURE

Additional biopsies

Additional biopsy samples from patients who are expected to receive treatment with pz-cel in the post-marketing setting.

BIOLOGICAL

Pz-cel surgical application to DEB wounds

This intervention is for patients requiring special access for application of pz-cel.

Sponsors & Collaborators

  • Abeona Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2031-11-30
Completion
2032-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07717736 on ClinicalTrials.gov