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

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ClinicalTrials.gov Identifier: NCT02579369
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Dystrophic Epidermolysis Bullosa Other: Allogeneic mesenchymal stem cells Device: Polyurethene Film Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Study Start Date : October 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: ALLO-ASC-DFU Other: Allogeneic mesenchymal stem cells
Dressing for Dystrophic Epidermolysis Bullosa wound.
Other Name: ALLO-ASC-DFU

Active Comparator: Conventional Therapy Device: Polyurethene Film
Dressing for Dystrophic Epidermolysis Bullosa wound.




Primary Outcome Measures :
  1. Area of re-epithelization [ Time Frame: Follow up to 8 weeks ]

Secondary Outcome Measures :
  1. Percentage of a target wound's re-epithelialization [ Time Frame: Every time of visit for follow up to 8 weeks ]
  2. Time taken to re-epithelization [ Time Frame: Over 8 weeks ]
  3. Safety assessed by clinically measured abnormality of laboratory tests and adverse events [ Time Frame: Over 8 weeks ]


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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579369


Contacts
Contact: Su Chan Kim, PhD. +82 2 2019-3362 kimsc@yuhs.ac

Locations
Korea, Republic of
Gangnam Severence Hospital Recruiting
Gangnam Gu, Seoul, Korea, Republic of, 135-720
Contact: Su Chan Kim, PhD.    +82 2 2019 3362`    kimsc@yuhs.ac   
Principal Investigator: Suchan Kim, PhD.         
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: Su Chan Kim, PhD. Gangnam Severence Hospital

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT02579369     History of Changes
Other Study ID Numbers: ALLO-ASC-EB-101
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Anterogen Co., Ltd.:
Epidermolysis Bullosa
stem cell

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Collagen Diseases
Connective Tissue Diseases