A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-09

Study Completion Date

2036-08-31

Brief Summary

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A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

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Detailed Description

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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.

Conditions

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RDEB

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long-Term Extension

This study will follow one group of participants who were enrolled in a previous EB-101 study.

EB-101

Intervention Type BIOLOGICAL

This is non-interventional and follows patients treated with EB-101

Interventions

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EB-101

This is non-interventional and follows patients treated with EB-101

Intervention Type BIOLOGICAL

Other Intervention Names

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pz-cel

Eligibility Criteria

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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.