Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
NCT ID: NCT02579369
Last Updated: 2023-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2015-12-08
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ALLO-ASC-DFU
Allogeneic mesenchymal stem cells
Dressing for Dystrophic Epidermolysis Bullosa wound.
Conventional Therapy
Polyurethene Film
Dressing for Dystrophic Epidermolysis Bullosa wound.
Interventions
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Allogeneic mesenchymal stem cells
Dressing for Dystrophic Epidermolysis Bullosa wound.
Polyurethene Film
Dressing for Dystrophic Epidermolysis Bullosa wound.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
3. Bullous skin lesion sized over 10 cm\^2
4. Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
5. 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
2. A subject who requires antibiotics due to bacterial infection on skin.
3. 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.
4. A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
5. A subject treated with steroids locally, within 30 days prior to screening.
6. A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
7. A subject with 2-times the maximum-standardized value of BUN, Creatinine
8. A subject with Albumin below 2.0 g/dL.
9. A subject with Hemoglobin below 6 g/dL (anemic).
10. A subject with allergic response to bovine derived protein and fibrin glue.
11. A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
12. A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
13. A subject who enrolled into another clinical trial, within 30 days prior to screening
14. A subject with serious disease that can affect on clinical trial.
15. A pregnant or breast-feeding subject.
16. A subject with history of drug abuse within 1 year of clinical significance
17. A subject who cannot proceed according to the protocol.
10 Years
60 Years
ALL
No
Sponsors
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Anterogen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Su Chan Kim, PhD.
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severence Hospital
Locations
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Gangnam Severence Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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ALLO-ASC-EB-101
Identifier Type: -
Identifier Source: org_study_id
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