Clinical trial
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Name
EB-101-LT-001
Description
A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Trial arms
Trial start
2021-02-09
Estimated PCD
2036-02-01
Trial end
2036-08-01
Treatment
EB-101
This is non-interventional and follows patients treated with EB-101
Arms:
Long-Term Extension
Size
22
Primary endpoint
Wound Closure
5 years
Pain Reduction
5 years
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;
* Prior study treatment with EB-101.
Exclusion Criteria:
* Inability to properly follow protocol as determined by the Principal Investigator
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 22, 'type': 'ESTIMATED'}}
Updated at
2023-02-03
1 organization
1 product
1 indication
Product
EB-101Organization
Abeona Therapeutics