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

Seoul National University Hospital24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rotator Cuff Tear

Interventions

allogenic adipose stem cell injectionBIOLOGICAL

Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.

fibrin glue/normal saline injectionBIOLOGICAL

Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise

normal saline injectionBIOLOGICAL

Total 1cc of normal saline injection and range of motion exercise

Eligibility

Sex: ALLMin age: 19 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

Change of Pain During Activity From Baseline to 3 Months After Intervention

Pain during activity will be evaluated by visual analog scale (active pain VAS). The active pain visual analog scale change from baseline to 3 months after intervention is the primary outcome. Visual analog scale is scored 0 to 10, higher scored meaning worse outcome. Negative values in change of pain during activity indicate improvement in pain.

Time frame: Baseline and 3 months after intervention

Secondary Outcomes

Pain During Rest

Pain during rest assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome.

Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

Pain During Activity

Pain during activity assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome

Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

American Shoulder and Elbow Surgeons (ASES) Shoulder Score

Functional score of the shoulder was assessed by American Shoulder and Elbow Surgeons shoulder score which is a questionnaire dedicated to the functional evaluation of the shoulder. It is scored from 0 to 100, higher scores meaning better outcome.

Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

Disability of Arm, Shoulder and Hand (DASH) Score

Shoulder function is assessed by DASH score which is questionnaire dedicated to evaluate the function of the upper extremity. It is scored from 0 (no disability) to 100 (most severe disability).

Time frame: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

University of California, Los Angeles(UCLA) Shoulder Score

Data from ClinicalTrials.gov

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