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

Phase 1

Completed

• Conditions: Dystrophic Epidermolysis Bullosa
• Interventions: Other: Allogeneic mesenchymal stem cells; Device: Polyurethene Film

• Registration Number: NCT02579369
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Study Start: 2015-12-08
• Primary Completion: 2016-04-01
• Study Completion: 2023-04-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALLO-ASC-DFU	Allogeneic mesenchymal stem cells	-
Conventional Therapy	Polyurethene Film	-

Primary Outcome Measures

Name	Time	Method
Area of re-epithelization	Follow up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of a target wound's re-epithelialization	Every time of visit for follow up to 8 weeks
Time taken to re-epithelization	Over 8 weeks
Safety assessed by clinically measured abnormality of laboratory tests and adverse events	Over 8 weeks

Trial Locations

Locations (1)

Gangnam Severence Hospital; 🇰🇷 Seoul, Korea, Republic of