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

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Brief Title

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

Official Title

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

Brief Summary

      After confirming eligibility, a single subject with two selected target lesions will receive
      both ALLO-ASC-SHEET and Vehicle control, one target lesion for each IP (one target lesion for
      ALLO-ASC-SHEET and the other target for Vehicle control), and which lesion to apply which IP
      will be determined randomly at the time of enrollment using IWRS.
    

Detailed Description

      Primary efficacy endpoint will be assessed at 5 weeks after up to 12th IP applications.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Incidence of Treatment-Emergent Adverse Events

Secondary Outcome

 Proportion of complete wound closure

Condition

Dystrophic Epidermolysis Bullosa

Intervention

ALLO-ASC-SHEET

Study Arms / Comparison Groups

 ALLO-ASC-SHEET
Description:  Allogeneic mesenchymal stem cells
Dressing for Dystrophic Epidermolysis Bullosa wound

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

6

Start Date

March 1, 2022

Completion Date

February 29, 2024

Primary Completion Date

April 1, 2023

Eligibility Criteria

        Key Inclusion Criteria:

          1. Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteria
             and one of the following:

               1. Immunostaining test: patients who have reduced or no type 7 collagen in staining
                  degree of immunofluorescence. Other antigens (laminin-332, type 17 collagen,
                  plectin, integrin α6β4, type 5 and type 14 keratin, etc.) are normal in
                  immune-staining.

               2. COL7A1 mutational analysis: confirmation of COL7A1 genetic mutation.

          2. Subject with skin ulcer lesions of dystrophic epidermolysis bullosa meet the following
             criteria, on the screening start day (Visit 1) and treatment start day (enrollment
             day) (Visit 3):

               1. Subject has two skin ulcer lesions judged as comparable to compare the safety and
                  efficacy by investigator during screening period and prior to the IP application
                  (enrollment day).

               2. Two skin ulcer lesions meeting criteria stated in 2a) should be sized 5-20 cm2
                  (inclusive)

          3. Subject who has two comparable target skin ulcer lesions, and each lesions with a
             change of size equal to or less than ±50% at treatment day (Visit 3) compared to that
             of screening day (Visit 1)

          4. Subject who has no clinical evidence of infection related signs/symptoms, or visible
             necrosis in the target skin ulcer area (area including ulcer lesion and surrounding
             area where the IP is to be applied).

        Key Exclusion Criteria:

          1. Subject who requires antibiotics due to bacterial infection on skin of the target skin
             ulcer area (area including ulcer lesion and surrounding area where the IP is to be
             applied).

          2. Female subjects: pregnant woman (indicated by serum hCG test result at screening),
             breast-feeding patient, all sexually active patient, with child bearing potential in
             case of female*, who is not willing to contracept** during the clinical trial.
      

Gender

All

Ages

4 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT05157958

Organization ID

ALLO-ASC-DEB-201


Responsible Party

Sponsor

Study Sponsor

Anterogen Co., Ltd.


Study Sponsor

, , 


Verification Date

December 2021