Status:
COMPLETED
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
Lead Sponsor:
Seoul National University Hospital
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
19-90 years
Phase:
PHASE2
Brief Summary
Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with supraspinatus ...
Detailed Description
Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. Double blind Randomized placebo controlled study will be done with f...
Eligibility Criteria
Inclusion
- clinically diagnosed as rotator cuff tear (supraspinatus partial thickness tear)
- recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- symptom duration is over 3 months
- supraspinatus partial thickness tear proven ultrasonography and magnetic resonance image(MRI)
- patient that can understand the clinical trials
Exclusion
- patient that underwent other injection treatment within 6 weeks
- some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,. arthritis of related joint to the target lesion, muscle weakness or atrophy, innervated by suprascapular nerve, paralysis of related joint to target lesion, proximal humeral fracture, infectious disease, bilateral rotator cuff tear, generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue and contraindication to MRI
- patient that enrolled other clinical trials within 30 days
- history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02298023
Start Date
September 1 2014
End Date
April 10 2018
Last Update
October 19 2021
Active Locations (1)
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1
Seoul National University College of Medicine
Seoul, South Korea