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NCT03183804 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03183804
Other study ID # ALLO-ASC-DFU-202
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 29, 2015
Est. completion date October 24, 2018

Study information
Verified date August 2023
Source Anterogen Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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-DFU-201) for 23 months.

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-DFU-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 Diabetic Foot Ulcer.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date October 24, 2018
Est. primary completion date August 17, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.
Other:
• Standard therapy
Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.

Locations
Country Name City State
Korea, Republic of Asan medical center Seoul
Korea, Republic of Eulji General Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability Evaluation of AE up to 24 months
See also
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