NCT03183648

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial

A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-BI-201

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Anterogen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

Detailed description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months. 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 burn.

Conditions

• Burn

Interventions

Type	Name	Description
BIOLOGICAL	ALLO-ASC-DFU	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 burn. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells

Timeline

• Start date: 2016-08-29
• Primary completion: 2020-04-02
• Completion: 2023-06-01
• First posted: 2017-06-12
• Last updated: 2023-08-25

Locations

1 site across 1 country: South Korea