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

Anterogen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dystrophic Epidermolysis Bullosa

Treatments: Device: Polyurethene Film; Other: Allogeneic mesenchymal stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT02579369

ALLO-ASC-EB-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

ALLO-ASC-DFU

Experimental group

Treatment:

Other: Allogeneic mesenchymal stem cells

Conventional Therapy

Active Comparator group

Treatment:

Device: Polyurethene Film