CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
LZRSE-Col7A1 Engineered Autologous Epidermal Sheetsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01263379
NCT01263379Phase 2Completed
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A Phase 1/2A Single Center Trial of Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Using the Drug LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

Abeona Therapeutics, Inc·interventional·Posted Dec 20, 2010·Updated Aug 22, 2023

In Brief

A Phase 2 clinical trial evaluating LZRSE-Col7A1 Engineered Autologous Epidermal Sheets for Epidermolysis Bullosa Dystrophica and Epidermolysis Bullosa. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This trial will create a skin graft, which the investigators call "LEAES," using the patient's own skin cells that have been genetically engineered in the lab to express a missing protein called type VII collagen. The corrected cells will be transplanted back to the patient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpidermolysis Bullosa Dystrophica, Epidermolysis Bullosa
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Stanford University

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2010
Enrollment StartOct 5, 2010
Primary CompletionMar 9, 2022
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 15.5 years ago

Interventions

LZRSE-Col7A1 Engineered Autologous Epidermal Sheetsbiological

This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.