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Stem Cell Therapy

ALLO-ASC-SHEET for Epidermolysis Bullosa

Phase 2
Recruiting
Research Sponsored by Anterogen Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteria and one of the following: Immunostaining test showing reduced or no type 7 collagen in staining degree of immunofluorescence, or confirmation of COL7A1 genetic mutation
Subject with skin ulcer lesions of dystrophic epidermolysis bullosa meeting specific criteria on the screening start day and treatment start day
Must not have
Subject who requires antibiotics due to bacterial infection on skin of the target skin ulcer area
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first application to week 37
Awards & highlights
No Placebo-Only Group

Summary

This trial will randomly assign one person's lesions to receive either a new treatment or the control treatment to test its efficacy.

Who is the study for?
This trial is for individuals with dystrophic epidermolysis bullosa, confirmed by specific tests. Participants must have skin ulcers between 5-20 cm2 in size that are stable and not infected. Women who are pregnant, breastfeeding, or not using contraception if of childbearing potential cannot join.
What is being tested?
The study involves applying a new treatment called ALLO-ASC-SHEET to three skin lesions and a placebo (Vehicle control) to one lesion on the same person. The assignment of treatments to each lesion is decided randomly at enrollment.
What are the potential side effects?
While the side effects aren't specified here, typical concerns may include local reactions like redness or discomfort at the site where ALLO-ASC-SHEET is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with dystrophic epidermolysis bullosa confirmed by specific tests.
Select...
I have specific types of skin ulcers due to dystrophic epidermolysis bullosa.
Select...
I have two similar skin ulcers, each 5-20 cm2, that haven't changed much in size recently.
Select...
My skin ulcer shows no signs of infection or dead tissue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need antibiotics for a bacterial infection in the area of my skin ulcer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first application to week 37
This trial's timeline: 3 weeks for screening, Varies for treatment, and first application to week 37 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Proportion of complete wound closure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ALLO-ASC-SHEETExperimental Treatment1 Intervention
Allogeneic mesenchymal stem cells Dressing for Dystrophic Epidermolysis Bullosa wound
Group II: Conventional TherapyActive Control1 Intervention
Hydrogel Sheet Matching control

Find a Location

Who is running the clinical trial?

Anterogen Co., Ltd.Lead Sponsor
30 Previous Clinical Trials
965 Total Patients Enrolled
2 Trials studying Epidermolysis Bullosa
4 Patients Enrolled for Epidermolysis Bullosa

Media Library

ALLO-ASC-SHEET (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05157958 — Phase 2
Epidermolysis Bullosa Research Study Groups: ALLO-ASC-SHEET, Conventional Therapy
Epidermolysis Bullosa Clinical Trial 2023: ALLO-ASC-SHEET Highlights & Side Effects. Trial Name: NCT05157958 — Phase 2
ALLO-ASC-SHEET (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157958 — Phase 2
~2 spots leftby Oct 2025
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