NCT02579369

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Anterogen Co., Ltd. · Industry
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dystrophic Epidermolysis Bullosa

Interventions

Type	Name	Description
OTHER	Allogeneic mesenchymal stem cells	Dressing for Dystrophic Epidermolysis Bullosa wound.
DEVICE	Polyurethene Film	Dressing for Dystrophic Epidermolysis Bullosa wound.

Timeline

• Start date: 2015-12-08
• Primary completion: 2016-04-01
• Completion: 2023-04-30
• First posted: 2015-10-19
• Last updated: 2023-08-25

Locations

1 site across 1 country: South Korea