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Also known as LEAES
LZRSE-Col7A1 Engineered Autologous Epidermal Sheets · 1 trial · 2 indications
The graft site was clinically evaluated by the investigator with a global score of: 1) 100% to 75% healed, 2) 74% to 50% healed, 3) 49% or less healed with 100% meaning completely healed.
Percentage of wound area will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Dimensions of untreated wounded skin will be used for comparison
| Arm | Type | Description |
|---|---|---|
| LEAES treatment | EXPERIMENTAL | LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) |
| Name | Type | Description |
|---|---|---|
| LZRSE-Col7A1 Engineered Autologous Epidermal Sheets | BIOLOGICAL | 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. |
Inclusion Criteria: 1. Clinical diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) 2. 13 years old or older and willing and able to give assent/consent 3. Confirmation of RDEB diagnosis by immunofluorescence (IF) and electron microscopy (EM) 4. NC1\[+\] and mAb LH24 antibody staining ne...
LZRSE-Col7A1 Engineered Autologous Epidermal Sheets is an investigational cell-based therapy developed by Abeona Therapeutics Inc. for epidermolysis bullosa dystrophica, a rare genetic skin disorder. It consists of a patient's own epidermal sheets that have been genetically engineered, and it has been studied in a single Phase 1 clinical trial.
LZRSE-Col7A1 Engineered Autologous Epidermal Sheets is being developed for the treatment of epidermolysis bullosa dystrophica, a rare inherited condition that causes fragile skin and chronic blistering. The therapy is intended for patients with this condition and was evaluated in a Phase 1 trial that enrolled 12 participants.
LZRSE-Col7A1 Engineered Autologous Epidermal Sheets is being developed by Abeona Therapeutics Inc., a biopharmaceutical company whose common stock trades under the ticker symbol ABEO. Abeona focuses on cell and gene therapies for rare diseases, and this asset is part of its pipeline for epidermolysis bullosa dystrophica.
LZRSE-Col7A1 Engineered Autologous Epidermal Sheets is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 trial has been completed, and no active trials for this asset are currently listed.
LZRSE-Col7A1 Engineered Autologous Epidermal Sheets has been studied in one clinical trial, NCT01263379, titled Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa. This completed Phase 1 trial enrolled 12 participants in the United States, included patients aged 13 years and older of all sexes, and was uncontrolled and open-label.