Phase 2
N=24
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT02298023 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change of Pain During Activity From Baseline to 3 Months After Intervention — -1.4; -1.5; -3.0 units on a scale — p=0.35
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- allogenic adipose stem cell injection (Biological); fibrin glue/normal saline injection (Biological); normal saline 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 of Pain During Activity From Baseline to 3 Months After Intervention |
-1.4; -1.5; -3.0 | 0.35 |
| SECONDARY Pain During Rest |
3.9; 2.4; 3.6; 4.0; 2.2; 3.0 | 0.662 |
| SECONDARY Pain During Activity |
5.7; 4.7; 6.6; 6.0; 3.2; 4.6 | 0.882 |
| SECONDARY American Shoulder and Elbow Surgeons (ASES) Shoulder Score |
58.9; 64.7; 54.7; 52.4; 70.6; 65.9 | 0.835 |
| SECONDARY Disability of Arm, Shoulder and Hand (DASH) Score |
32.3; 35.2; 37.6; 36.7; 25.8; 28.1 | 0.977 |
| SECONDARY University of California, Los Angeles(UCLA) Shoulder Score |
20.3; 19.0; 17.5; 20.0; 22.3; 22.9 | 0.867 |
| SECONDARY Tear Size at 3 Months After Injection |
5; 5; 5; 2; 2; 2 | 0.916 |
| SECONDARY Tear Size at 12 Months After Injection |
4; 3; 4; 1; 3; 2 | 0.892 |
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 partial thickness tear by ultrasonographic guided injection.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02298023). 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.