{ "data": { "asOf": "2026-10-30T22:26:37.422Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07717736", "title": "Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds", "scientificTitle": "Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [ "PHASE4" ], "conditions": [ "Epidermolysis Bullosa (EB)", "Recessive Dystrophic Epidermolysis Bullosa (RDEB)", "Dystrophic Epidermolysis Bullosa (DEB)" ], "interventions": [ { "name": "Non-conforming pz-cel surgical application to RDEB wounds", "type": "BIOLOGICAL", "description": "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." }, { "name": "Additional biopsies", "type": "PROCEDURE", "description": "Additional biopsy samples from patients who are expected to receive treatment with pz-cel in the post-marketing setting." }, { "name": "Pz-cel surgical application to DEB wounds", "type": "BIOLOGICAL", "description": "This intervention is for patients requiring special access for application of pz-cel." } ], "sponsor": { "name": "Abeona Therapeutics, Inc", "type": "INDUSTRY" }, "locations": [], "outcomes": { "other": [ "Study A - The number of treatment-related cutaneous malignancies.", "Study A - The number of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)", "Study A - The number of positive replication-competent retrovirus (RCR) testing results", "Study A - The number of all treatment-emergent AEs and SAEs.", "Study C - The number of treatment-related cutaneous malignancies.", "Study C - The number of treatment-emergent AEs and SAEs", "Study C - The number of positive RCR testing results required for AEs and SAEs", "Study C - The number of all treatment-emergent AEs and SAEs." ], "primary": [ "Study A - Wound Healing ≥50%", "Study A - Pain Severity Scale (Wong-Baker FACES)", "Study C - Wound Healing ≥50%", "Study C - Pain Severity Scale (Wong-Baker FACES)" ], "secondary": [ "Study A - Wound Healing ≥50%", "Study A - Wound Healing ≥75%", "Study A - Wound Healing Complete", "Study A - Pain Severity Scale (Wong-Baker FACES)", "Study A - Worst Itch Severity Scale", "Study C - Wound Healing ≥50%", "Study C - Wound Healing ≥75%", "Study C - Wound Healing Complete", "Study C - Pain Severity Scale (Wong-Baker FACES)", "Study C - Worst Itch Severity Scale" ] }, "eligibility": { "sex": "ALL", "criteria": "Study A\n\nInclusion Criteria\n\n1. Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.\n2. Patients who are expected to receive pz-cel manufactured as intended for commercial treatment; however, the final manufactured product was non-conforming and therefore did not meet commercial release criteria.\n3. All women of childbearing potential should discuss reproductive and breastfeeding plans and precautions with the treating physician in accordance with the considerations for special populations in the United States Prescribing Information (USPI).\n\nExclusion Criteria\n\n1. Inability to adequately follow the protocol and ensure the protection of cellular sheet sites, as determined by the Investigator.\n2. Hypersensitivity to vancomycin or amikacin.\n3. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as, but not limited to, active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.\n4. Evidence of systemic infection.\n5. Current evidence of squamous cell carcinoma (SCC) in the area that will undergo pz-cel application.\n6. Grade 3 clinical event or laboratory abnormality prior to pz-cel treatment, with the exception of abnormalities such as esophageal strictures, anemia, low albumin, and pain/itch, which are expected in patients with severe DEB.\n7. Any other circumstance where the Investigator believes that it is not appropriate for the patient to participate in the study.\n\nStudy B\n\nInclusion Criteria\n\n1. Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.\n2. Patients who are expected to receive treatment with pz-cel and are receiving a biopsy prior to pz-cel application in the post-marketing setting.\n\nExclusion Criteria\n\n1\\. Any circumstance where the Investigator believes that the patient may not be appropriate for participation in the study.\n\nStudy C\n\nInclusion Criteria:\n\n1. Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.\n2. Patients who were prescribed pz-cel for commercial treatment but require special access defined in the protocol for treatment to occur.\n3. All women of childbearing potential must have a negative urine pregnancy test and agree to use a reliable birth control method throughout the duration of the study.\n\nExclusion Criteria:\n\n1. Inability to properly follow protocol assessments and protect cellular sheet sites as determined by the Investigator.\n2. Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat DEB or receipt of the investigational therapy within the 3 months prior to pz-cel application.\n3. Breastfeeding.\n4. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as, but not limited to, active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.\n5. Evidence of systemic infection.\n6. Current evidence or a history of SCC in the area that will undergo pz-cel application.\n7. Active drug or alcohol addiction.\n8. Hypersensitivity to vancomycin or amikacin.\n9. Grade 3 clinical event or laboratory abnormality prior to pz-cel treatment, with the exception of abnormalities such as esophageal strictures, anemia, low albumin, and pain/itch, which are expected in patients with severe DEB.\n10. 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