Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa

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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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Area of re-epithelization

Secondary Outcome

 Percentage of a target wound's re-epithelialization

Condition

Dystrophic Epidermolysis Bullosa

Intervention

Allogeneic mesenchymal stem cells

Study Arms / Comparison Groups

 ALLO-ASC-DFU
Description:  

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

Other

Estimated Enrollment

5

Start Date

October 2015

Completion Date

December 2017

Primary Completion Date

June 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Age : 10~60

          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:

          1. A subject with history of epidermoid carcinoma within a year from screening.

          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.
      

Gender

All

Ages

10 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Su Chan Kim, PhD., +82 2 2019-3362, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02579369

Organization ID

ALLO-ASC-EB-101


Responsible Party

Sponsor

Study Sponsor

Anterogen Co., Ltd.


Study Sponsor

Su Chan Kim, PhD., Principal Investigator, Gangnam Severence Hospital


Verification Date

January 2017