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