Dystrophic Epidermolysis Bullosa Clinical Trials

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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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Combination product
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago - Department of Dermatology
RECRUITING
Chicago
Texas
University of Texas Medical Branch
RECRUITING
Galveston
Contact Information
Primary
Angela Iheanacho
aiheanacho@abeonatherapeutics.com
646-813-7166
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2045-04
Participants
Target number of participants: 250
Treatments
Patients with RDEB who received pz-cel treatment in the post-marketing setting
Sponsors
Leads: Abeona Therapeutics, Inc

This content was sourced from clinicaltrials.gov