A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial

Anterogen

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Procedure: Vehicle sheet; Biological: ALLO-ASC-DFU

Study type: Observational

Funder types: Industry

Identifiers

NCT04590703

ALLO-ASC-DFU-303

Details and patient eligibility

About

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months

Full description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) 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 Diabetic Foot Ulcer.

Enrollment: 73 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion criteria

1. Subjects who are considered not suitable for the study by the principal investigator.

Trial design

73 participants in 2 patient groups

ALLO-ASC-DFU

Description:

Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-301

Treatment:

Biological: ALLO-ASC-DFU

Vehicle sheet

Description:

Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301

Treatment:

Procedure: Vehicle sheet