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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first application to week 37

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I have been diagnosed with dystrophic epidermolysis bullosa confirmed by specific tests.

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I have specific types of skin ulcers due to dystrophic epidermolysis bullosa.

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I have two similar skin ulcers, each 5-20 cm2, that haven't changed much in size recently.

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My skin ulcer shows no signs of infection or dead tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first application to week 37

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Proportion of complete wound closure

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Anterogen Co., Ltd.Lead Sponsor

29 Previous Clinical Trials

959 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for participants of this experiment?

"As directed by the study's entry conditions, patients should be at least 4 years old and not more than 60 for consideration."

Answered by AI

Are there currently any openings for prospective participants in this clinical trial?

"The clinical trial, which was launched on May 1st 2023 is still recruiting participants. Its most recent update occured on August 23rd 2023, as documented by clinicialtrials.gov."

Answered by AI

To what extent does the ALLO-ASC-SHEET procedure pose a risk to users?

"Because Phase 2 trials lack evidence of efficacy, the safety rating for ALLO-ASC-SHEET was conservatively set to a score of 2."

Answered by AI

What is the total capacity of this research project?

"Affirmative. According to clinicaltrials.gov, this medical experiment is currently seeking participants; the project was first advertised on May 1st 2023 and has recently been updated on August 23rd 2023. 6 individuals need to be recruited from a single location for the trial's completion."

Answered by AI

Is it possible to sign up for participation in this research project?

"This investigation is enrolling 6 patients afflicted with epidermolysis bullosa between the ages of 4 and 60. To be eligible, participants must have reduced or no type 7 collagen in immunofluorescence staining, normal antigens (laminin-332, type 17 collagen etc.), COL7A1 genetic mutation confirmed through mutational analysis, two target skin ulcer lesions measuring 5-20 cm2 each that show minimal change from screening to treatment day; absence of infection related signs/symptoms or visible necrosis in the area where IP will be applied."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157958.

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