Clinical Trials Directory

Trials / Completed

CompletedNCT03183934

A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial

A Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101

Status
Completed
Phase
Study type
Observational
Enrollment
2 (actual)
Sponsor
Anterogen Co., Ltd. · Industry
Sex
All
Age
2 Years – 60 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 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.

Detailed description

This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 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 Dystrophic Epidermolysis Bullosa.

Conditions

Interventions

TypeNameDescription
BIOLOGICALALLO-ASC-DFUALLO-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 Dystrophic Epidermolysis Bullosa. This study is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells

Timeline

Start date
2017-12-08
Primary completion
2018-04-20
Completion
2023-04-30
First posted
2017-06-12
Last updated
2023-08-25

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03183934. Inclusion in this directory is not an endorsement.

A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial (NCT03183934) · Clinical Trials Directory