Status:
COMPLETED
Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Korea Health Industry Development Institute
Conditions:
Lateral Epicondylitis
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the efficacy and safety of intra-tendon injection of allogeneic adipose-derived mesenchymal stem cells (Allo-ASC) in intractable common extensor tendinosis patient...
Detailed Description
A phase II randomized placebo controlled trial will be done with following 3 groups. Each group will have 10 participants, so, the total patients will be 30 people. 1. High concentration of Allo-ASC ...
Eligibility Criteria
Inclusion
- clinically diagnosed as lateral epicondylosis (tennis elbow)
- symptom duration is over 12 months
- pain visual analogue scale (VAS) during activity ≥ 5
- recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- common extensor tendon injury can be observed under ultrasound (hypoechoic lesion) and MRI (hyperintensity or discontinuity)
- patient that can understand the clinical trials
Exclusion
- patient that underwent other injection such as steroid injection or prolotherapy within 6 weeks
- patients with following conditions (such as arthritis related to the target lesion, synovitis related to the target lesion, paralysis related to the target lesion, entrapment of related nerve to the target lesion, radiculopathy related to the target lesion, infectious disease, generalized pain syndrome, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or Fibrin Glue, contraindication to MRI)
- patient that enrolled other clinical trials within 30 days
- current pregnancy or breast-feeding, planning for pregnancy
- history of drug/alcohol addiction, habitual smoker
- operation history of affected elbow
- previous clinical trial involving stem cell administration
- other severe medical illness or bleeding tendency
- size of intramural calcification over 2.0 mm under ultrasound evaluation
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03449082
Start Date
March 15 2018
End Date
March 8 2021
Last Update
April 6 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea