Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells

Study Overview
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Brief Summary
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This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1*10^6 cells as an unit. Patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1*10^6/10kg) while the control group received the same dose compound betamethasone injection. Follow up visit for all patients will occur at 1，3，6 and 12 months after the first injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

Detailed Description
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All injection will be done under ultrasound guidance.

Official Title
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Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Tendon Disease: a Randomized Controlled Trial

Conditions
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Rotator Cuff Tear, Lateral Epicondylitis

Intervention / Treatment
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* Biological: Autologous adipose-derived MSCs
* Drug: Compound betamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically diagnosed as rotator cuff tear or lateral epicondylitis (tennis elbow); symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid; patient that can understand the clinical trials and signed the informed consent. 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 3 months history of drug/alcohol addiction, habitual smoker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous adipose-derived MSCs<br>The dose of adipose-derived mesenchymal stem cells was related to body weight, and 1 × 10 ^ 6 cells were a unit. One unit of adipose-derived mesenchymal stem cells was injected every 10 kg of body weight and injected once a week for three times. | Biological: Autologous adipose-derived MSCs<br>* The dose of adipose-derived mesenchymal stem cells was related to body weight, and 1 × 10 ^ 6 cells were a unit. One unit of adipose-derived mesenchymal stem cells was injected every 10 kg of body weight and injected once a week for three times.<br>|
| Active Comparator: Compound betamethasone<br>1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume with the cell suspension (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ), once a week for three times. | Drug: Compound betamethasone<br>* 1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume with the cell suspension (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ), once a week for three times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks | Pain on activity will be evaluated by VAS | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Constant-Murley Score(CMS) at 3, 6 and 12 weeks, | Functional score of the shoulder | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | Functional score of the shoulder | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 
| The Disabilities of the Arm, Shoulder and Hand(DASH) Score | Functional score of the shoulder | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 
| Adverse events | Adverse events to evaluate the safety | From baseline through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adipose-drived mesenchymal stem cells, Rotator cuff injury, Lateral Epicondylitis, Randomized controlled trials