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
Recruiting
Observational Study
Recessive Dystrophic Epidermolysis Bullosa
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 250 (estimated)
- Sponsor
- Abeona Therapeutics, Inc · Industry
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About This Trial
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…
Trial Locations
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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 protoco…
Contacts