- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05708677
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
February 1, 2023 updated by: Abeona Therapeutics, Inc
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Study Overview
Detailed Description
This is an open-label, long-term, follow-up study in participants from prior interventional trials involving surgical application of gene-corrected keratinocyte sheets (EB-101) for the treatment of RDEB wound sites.
Up to 22 participants will be enrolled in this study, with follow-up through at least 5 years post treatment.
Patient-reported outcomes and safety will be assessed throughout the study, and where applicable, compared to Baseline of the preceding interventional EB-101 trial.
Upon completion, participants will transfer to an annual monitoring program for additional 10 years of phone visits.
Study Type
Observational
Enrollment (Anticipated)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Redwood City, California, United States, 94063
- Stanford University
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- University of Massachusetts Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with previous EB-101 treatment
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Long-Term Extension
This study will follow one group of participants who were enrolled in a previous EB-101 study.
|
This is non-interventional and follows patients treated with EB-101
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Closure
Time Frame: 5 years
|
Proportion of RDEB wounds with healing ≥50%, ≥75%, and 100% at all clinic visits up to Month 54 as determined by direct investigator assessment.
|
5 years
|
Pain Reduction
Time Frame: 5 years
|
Pain reduction assessed by Wong-Baker FACES scale at all clinic visits up to Month 54.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 9, 2021
Primary Completion (ANTICIPATED)
February 1, 2036
Study Completion (ANTICIPATED)
August 1, 2036
Study Registration Dates
First Submitted
January 23, 2023
First Submitted That Met QC Criteria
January 23, 2023
First Posted (ACTUAL)
February 1, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 3, 2023
Last Update Submitted That Met QC Criteria
February 1, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EB-101-LT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on RDEB
-
Abeona Therapeutics, IncRecruitingEpidermolysis Bullosa | Recessive Dystrophic Epidermolysis Bullosa | RDEBUnited States
Clinical Trials on EB-101
-
Abeona Therapeutics, IncRecruitingEpidermolysis Bullosa | Recessive Dystrophic Epidermolysis Bullosa | RDEBUnited States
-
Abeona Therapeutics, IncCompletedEpidermolysis Bullosa | Recessive Dystrophic Epidermolysis BullosaUnited States
-
Neurovance, Inc.CompletedNormal, Healthy VolunteersAustralia
-
Ruggeri, MirellaRecruiting
-
Peking Union Medical College HospitalRecruiting
-
Epibone, Inc.RecruitingMandible; Deformity | Mandibular Injuries | Mandible TumorUnited States
-
Otsuka Pharmaceutical Development & Commercialization...CompletedAttention Deficit Hyperactivity DisorderUnited States
-
Peking Union Medical College HospitalNational Institute for Biomedical Imaging and Bioengineering (NIBIB)RecruitingMetastatic Castration-resistant Prostate CancerChina
-
Vedic Lifesciences Pvt. Ltd.RecruitingMuscle Mass and StrengthIndia
-
Bonti, Inc.Completed