- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183726
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial
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
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-DFU-101.
- 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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ALLO-ASC-DFU treatment
Subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial of ALLO-ASC-DFU-101
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 24 months
|
Evaluation of AE
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound size and depth measurement
Time Frame: 6, 12, 24 months
|
Evaluation of the improvement of wound measured by size and depth, and examines the change for 23 months period
|
6, 12, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyun-suk Suh, MD, PhD, Asan Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALLO-ASC-DFU-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
Clinical Trials on ALLO-ASC-DFU
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Anterogen Co., Ltd.CompletedDiabetic Foot UlcerKorea, Republic of
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Anterogen Co., Ltd.Completed
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Anterogen Co., Ltd.RecruitingDiabetic Foot UlcerKorea, Republic of
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Anterogen Co., Ltd.RecruitingDiabetic Foot UlcerKorea, Republic of
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Anterogen Co., Ltd.CompletedDiabetic Foot UlcerKorea, Republic of
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Anterogen Co., Ltd.CompletedDystrophic Epidermolysis BullosaKorea, Republic of
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Anterogen Co., Ltd.CompletedDiabetic Foot UlcerKorea, Republic of
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Anterogen Co., Ltd.CompletedClinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot UlcersDiabetic Foot UlcerKorea, Republic of
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Anterogen Co., Ltd.CompletedBurn InjuryKorea, Republic of
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Anterogen Co., Ltd.CompletedDystrophic Epidermolysis BullosaKorea, Republic of