NCT07700966 A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting
| NCT ID | NCT07700966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abeona Therapeutics, Inc |
| Condition | Recessive Dystrophic Epidermolysis Bullosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2045-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-07-25 with a primary completion date of 2045-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to evaluate the long-term safety and wound healing durability (up to 15 years) for participants with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who were treated with pz-cel. The main questions it aims to answer are: * The long-term safety profile of pz-cel. * The wound healing durability of pz-cel. * The occurrence of all malignancies after treatment with pz-cel, regardless of type or location, in individuals who received pz-cel treatment for RDEB in the post-marketing setting. Participants will then be followed annually up to 15 years post-treatment. Assessments will occur via remote data collection. If the participants provider determines an office visit is necessary after the first year, some of this data can be collected in person as well. Annual assessments will include, but are not limited to: * Review of Adverse Events (AEs), Serious Adverse Events (SAEs), hospitalizations, and any evidence of malignancies and potential retroviral infection * Wound-healing durability data collection via the modified Caregiver Global Impression of Change for Wound Healing * Any changes in concomitant medications and procedures.
Eligibility Criteria
Inclusion Criteria: * Willing and able to give consent/assent; if under the age of 18, guardian(s) is(are) willing and able to give consent. * Patients who received treatment with prademagene zamikeracel in the post-marketing setting. Exclusion Criteria: • Inability to properly follow the protocol as determined by the Principal Investigator (PI).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07700966 clinical trial?
This trial is open to participants of all sexes, studying Recessive Dystrophic Epidermolysis Bullosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07700966 currently recruiting?
Yes, NCT07700966 is actively recruiting participants. Contact the research team at aiheanacho@abeonatherapeutics.com for enrollment information.
Where is the NCT07700966 trial being conducted?
This trial is being conducted at Palo Alto, United States, Aurora, United States, Chicago, United States, Galveston, United States.
Who is sponsoring the NCT07700966 clinical trial?
NCT07700966 is sponsored by Abeona Therapeutics, Inc. The trial plans to enroll 250 participants.