Status:
COMPLETED
Treatment of Tendon Injury Using Mesenchymal Stem Cells
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Medical Research Collaborating Center, Seoul, Korea
Conditions:
Lateral Epicondylitis
Eligibility:
All Genders
19-90 years
Phase:
EARLY_PHASE1
Brief Summary
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 patient...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- clinically diagnosed as lateral epicondylitis (tennis elbow)
- recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- symptom duration is over 6 months
- defect in common extensor tendon can be observed under ultrasound
- patient that can understand the clinical trials
Exclusion
- patient that underwent other injection treatment within 6 weeks
- some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
- patient that enrolled other clinical trials within 30 days
- history of drug/alcohol addiction, habitual smoker
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01856140
Start Date
May 1 2013
End Date
April 1 2018
Last Update
March 18 2022
Active Locations (1)
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1
Seoul National University College of Medicine
Seoul, South Korea