NCT02619877

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers

Phase 2 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Comparator-controlled, Single-blind, Parallel-group, Multi-center Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Anterogen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.

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 a new option in treating a Diabetic Foot Ulcer.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	ALLO-ASC-DFU	Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
OTHER	Standard therapy	Standard therapy conducted for patients with diabetic foot ulcer

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2015-12-02
• Last updated: 2017-09-01

Locations

4 sites across 1 country: South Korea