Early Phase 1
N=12
Treatment of Tendon Injury Using Mesenchymal Stem Cells
Lateral Epicondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01856140 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection (Biological)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Jul 2016
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 |
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.
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.