RecruitingPhase 2NCT05157958

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

Double Blind, Randomized, Phase II Clinical Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET Versus Vehicle Control in Dystrophic Epidermolysis Bullosa (DEB) Patients


Sponsor

Anterogen Co., Ltd.

Enrollment

6 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.


Eligibility

Min Age: 4 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a stem cell skin sheet treatment (ALLO-ASC-SHEET) for people with dystrophic epidermolysis bullosa (DEB) — a rare inherited skin disease where the skin blisters and breaks easily, causing painful sores that are hard to heal. You may be eligible if: - You are 4–60 years old - You have a confirmed diagnosis of dystrophic epidermolysis bullosa (by genetic testing or immunostaining) - You have two open skin ulcer sores that are each 5–20 cm² in size - The sores show no signs of infection or dead tissue - You are willing to use contraception during the study if you are able to have children You may NOT be eligible if: - Your skin ulcer area has a bacterial infection requiring antibiotics - You are pregnant, breastfeeding, or sexually active without contraception and able to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALALLO-ASC-SHEET

Weekly administration

OTHERVehicle Control

Weekly administration


Locations(1)

University of Miami Dermatology Clinical Trials Unit

Miami, Florida, United States

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NCT05157958


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