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

Phase 2

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Biological: normal saline injection; Biological: fibrin glue/normal saline injection; Biological: allogenic adipose stem cell injection

• Registration Number: NCT02298023
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Primary Completion: 2016-07-19
• Study Completion: 2018-04-10
• Results First Submitted: 2020-06-11
• Results First Submitted QC: 2021-06-09
• Results First Posted: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (normal saline )group	normal saline injection	Received only normal saline.
Active control (fibrin glue) group	fibrin glue/normal saline injection	Received fibrin glue and normal saline.
Mesenchymal stem cell group	allogenic adipose stem cell injection	Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.

Primary Outcome Measures

Name	Time	Method
Change of Pain During Activity From Baseline to 3 Months After Intervention	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Pain During Activity	Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention	Pain during activity assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome
American Shoulder and Elbow Surgeons (ASES) Shoulder Score	Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention	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.
University of California, Los Angeles(UCLA) Shoulder Score	Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention	Shoulder function is assessed by UCLA shoulder score which is a composite of range of motion examination and questionnaire dedicated to evaluate the function of the shoulder. It is scored from 0 to 35, higher scores meaning better shoulder function.
Tear Size at 3 Months After Injection	baseline and 3 months after intervention	Tear size was evaluated by 3-point Likert scale using MRI. The 3months follow-up images were compared to the baseline image and graded either; improved, stationary, and aggravated.
Pain During Rest	Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention	Pain during rest assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome.
Disability of Arm, Shoulder and Hand (DASH) Score	Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention	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).
Tear Size at 12 Months After Injection	baseline and12 months after intervention	Tear size was evaluated by 3-point Likert scale using MRI. The 12 months follow-up images were compared to the baseline image and graded either; improved, stationary, and aggravated.

Trial Locations

Locations (1)

Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of