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NCT03183726 Clinical Trial

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 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 1 Clinical Trial of ALLO-ASC-DFU-101

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03183726
Other study ID # ALLO-ASC-DFU-102
Secondary ID
Status Completed
Phase N/A
First received June 8, 2017
Last updated January 8, 2018
Start date January 11, 2016
Est. completion date July 31, 2017

Study information
Verified date January 2018
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 1 clinical trial (ALLO-ASC-DFU-101) 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 1 clinical trial (ALLO-ASC-DFU-101) 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 4
Est. completion date July 31, 2017
Est. primary completion date June 30, 2017
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 1 clinical trial of ALLO-ASC-DFU-101.

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 (For example, Subjects requiring surgical procedure on target site).

Study Design

Related Conditions & MeSH terms

Intervention

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 an new option in treating a diabetic foot ulcer. This study is a follow-up study without intervention.

Locations
Country Name City State
n/a

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

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
Secondary Wound size and depth measurement Evaluation of the improvement of wound measured by size and depth, and examines the change for 23 months period 6, 12, 24 months
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