Early Phase 1
Completed N=12
Treatment of Tendon Injury Using Mesenchymal Stem Cells
Source: ClinicalTrials.gov NCT01856140 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks — 3.57; 3.02; 2.93; 1.60 score on a scale — p=0.52
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 patients with lateral epicondylitis by ultrasonographic guided injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks |
3.57; 3.02; 2.93; 1.60; 1.68; 0.87 | 0.52 |
| SECONDARY Modified Mayo Clinic Performance Index for the Elbow |
57.92; 70.00; 83.75; 90.41; 87.92; 91.67 | 0.227 |
| SECONDARY Defect Area of Tendon by Ultrasonography in Long Axis |
4197; 5246; 4163; 4383; 2381; 2516 | 0.262 |
| SECONDARY Defect Area of Tendon by Ultrasonography in Short Axis |
3726; 5018; 3797; 2849; 2703; 2223 | 0.337 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01856140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.