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

A

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

  • Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
  • 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

Trial contacts and locations

0

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Central trial contact

Seung-Kyu Han, MD. Ph D.

Data sourced from clinicaltrials.gov

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