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Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study
Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.
Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants). The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.
Age
19 - 90 years
Sex
ALL
Healthy Volunteers
No
Seoul National University College of Medicine
Seoul, South Korea
Start Date
May 1, 2013
Primary Completion Date
July 1, 2016
Completion Date
April 1, 2018
Last Updated
March 18, 2022
12
ACTUAL participants
ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
BIOLOGICAL
Lead Sponsor
Seoul National University Hospital
Collaborators
NCT07314840
NCT07004894
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06735092