Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Rotator Cuff Tear

Treatments: Biological: allogenic adipose stem cell injection; Biological: normal saline injection; Biological: fibrin glue/normal saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02298023

ALLO-ASC_TR

Details and patient eligibility

About

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.

Full 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 following 3 groups. Each group will have 8 people, so, the total patients will be 24 people.

1. Stem cell treatment group : stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc + range of motion exercise
2. Active control (fibrin glue) group : Normal saline 0.5cc + Fibrin glue 0.5cc + range of motion exercise
3. Control (normal saline) group : Normal saline 0.5cc + Normal saline 0.5cc + range of motion exercise

The investigators will compare the efficacy difference with VAS(visual analog scale, primary outcome), ASES(American Shoulder and Elbow Surgeons) Score, UCLA(University of California, Los Angles) Shoulder Score, DASH(The Disabilities of the Arm, Shoulder and Hand) Score and change of tear size compared to the baseline image assessed by MRI. These measurement will be done at 6 and 12 weeks after injections and long-term follow-up will be also planned to 6 months, 12months and 24 months except for the evaluation of the tear size which will be done at baseline, 3 months and 24 months after the intervention.

Enrollment: 24 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

Mesenchymal stem cell group

Experimental group

Description:

Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.

Treatment:

Biological: allogenic adipose stem cell injection

Active control (fibrin glue) group

Active Comparator group

Description:

Received fibrin glue and normal saline.

Treatment:

Biological: fibrin glue/normal saline injection

Control (normal saline )group

Placebo Comparator group

Description:

Received only normal saline.

Treatment:

Biological: normal saline injection