- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183934
A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial
A Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) 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 Dystrophic Epidermolysis Bullosa.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Su Chan Kim, PhD
- Phone Number: 82 2 2019 3362
- Email: kimsc@yuhs.ac
Study Locations
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-
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Seoul, Korea, Republic of, 135-720
- Gangnam Severence Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Time Frame: Every time of visit for follow up to 24 months
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
|
Every time of visit for follow up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area of re-epithelization
Time Frame: Every time of visit for follow up to 24 months
|
Time taken to re-epithelization
|
Every time of visit for follow up to 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Su Chan Kim, PhD, Gangnam Severence Hospital
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALLO-ASC-EB-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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