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

Dystrophic Epidermolysis Bullosa Clinical Trial

Official title:

A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579369
• Other study ID #: ALLO-ASC-EB-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 8, 2015
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2023
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 30, 2023
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Dystrophic Epidermolysis Bullosa
• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica

Intervention

Other:
• Allogeneic mesenchymal stem cells
Dressing for Dystrophic Epidermolysis Bullosa wound.

Device:
• Polyurethene Film
Dressing for Dystrophic Epidermolysis Bullosa wound.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severence Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of re-epithelization		Follow up to 8 weeks
Secondary	Percentage of a target wound's re-epithelialization		Every time of visit for follow up to 8 weeks
Secondary	Time taken to re-epithelization		Over 8 weeks
Secondary	Safety assessed by clinically measured abnormality of laboratory tests and adverse events		Over 8 weeks