Back to resultsStudy to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Primary Purpose
Dystrophic Epidermolysis Bullosa
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Allogeneic mesenchymal stem cells
Polyurethene Film
Sponsored by
About this trial
This is an interventional treatment trial for Dystrophic Epidermolysis Bullosa focused on measuring Epidermolysis Bullosa, stem cell
Eligibility Criteria
Inclusion Criteria:
- Age : 10~60
- Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
- Bullous skin lesion sized over 10 cm^2
- Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
- A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.
Exclusion Criteria:
- A subject with history of epidermoid carcinoma within a year from screening.
- A subject who requires antibiotics due to bacterial infection on skin.
- A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
- A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
- A subject treated with steroids locally, within 30 days prior to screening.
- A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
- A subject with 2-times the maximum-standardized value of BUN, Creatinine
- A subject with Albumin below 2.0 g/dL.
- A subject with Hemoglobin below 6 g/dL (anemic).
- A subject with allergic response to bovine derived protein and fibrin glue.
- A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
- A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
- A subject who enrolled into another clinical trial, within 30 days prior to screening
- A subject with serious disease that can affect on clinical trial.
- A pregnant or breast-feeding subject.
- A subject with history of drug abuse within 1 year of clinical significance
- A subject who cannot proceed according to the protocol.
Sites / Locations
- Gangnam Severence Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ALLO-ASC-DFU
Conventional Therapy
Arm Description
Outcomes
Primary Outcome Measures
Area of re-epithelization
Secondary Outcome Measures
Percentage of a target wound's re-epithelialization
Time taken to re-epithelization
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02579369
Brief Title
Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Official Title
A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2015 (Actual)
Primary Completion Date
April 1, 2016 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterogen Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
Detailed Description
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a Dystrophic Epidermolysis Bullosa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystrophic Epidermolysis Bullosa
Keywords
Epidermolysis Bullosa, stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALLO-ASC-DFU
Arm Type
Experimental
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Allogeneic mesenchymal stem cells
Other Intervention Name(s)
ALLO-ASC-DFU
Intervention Description
Dressing for Dystrophic Epidermolysis Bullosa wound.
Intervention Type
Device
Intervention Name(s)
Polyurethene Film
Intervention Description
Dressing for Dystrophic Epidermolysis Bullosa wound.
Primary Outcome Measure Information:
Title
Area of re-epithelization
Time Frame
Follow up to 8 weeks
Secondary Outcome Measure Information:
Title
Percentage of a target wound's re-epithelialization
Time Frame
Every time of visit for follow up to 8 weeks
Title
Time taken to re-epithelization
Time Frame
Over 8 weeks
Title
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Time Frame
Over 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age : 10~60
Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
Bullous skin lesion sized over 10 cm^2
Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.
Exclusion Criteria:
A subject with history of epidermoid carcinoma within a year from screening.
A subject who requires antibiotics due to bacterial infection on skin.
A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
A subject treated with steroids locally, within 30 days prior to screening.
A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
A subject with 2-times the maximum-standardized value of BUN, Creatinine
A subject with Albumin below 2.0 g/dL.
A subject with Hemoglobin below 6 g/dL (anemic).
A subject with allergic response to bovine derived protein and fibrin glue.
A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
A subject who enrolled into another clinical trial, within 30 days prior to screening
A subject with serious disease that can affect on clinical trial.
A pregnant or breast-feeding subject.
A subject with history of drug abuse within 1 year of clinical significance
A subject who cannot proceed according to the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Chan Kim, PhD.
Organizational Affiliation
Gangnam Severence Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severence Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
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