- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183622
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-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-BI-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-BI-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 burn.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Hallym University Medical Center
-
-
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-BI-101.
- A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.
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
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-BI-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 a new option in treating a burn. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells |
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 |
---|---|---|
Vancouver Burn Scar Scale
Time Frame: Every time of visit for follow up to 24 months
|
Evaluation of Vancouver Burn Scar Scale
|
Every time of visit for follow up to 24 months
|
Collaborators and Investigators
Sponsor
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
Keywords
Other Study ID Numbers
- ALLO-ASC-BI-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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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