Lateral Epicondylitis, Rotator Cuff Tear
Conditions
Keywords
Adipose-drived mesenchymal stem cells, Rotator cuff injury, Lateral Epicondylitis, Randomized controlled trials
Brief summary
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
All injection will be done under ultrasound guidance.
Interventions
BIOLOGICALAutologous adipose-derived MSCs
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.
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.
Sponsors
Zhejiang Xingyue Biotechnology Co., Ltd.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. clinically diagnosed as rotator cuff tear or lateral epicondylitis (tennis elbow); 2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid; 3. patient that can understand the clinical trials and signed the informed consent.
Exclusion criteria
1. patient that underwent other injection treatment within 6 weeks 2. 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) 3. patient that enrolled other clinical trials within 3 months 4. history of drug/alcohol addiction, habitual smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | Pain on activity will be evaluated by VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Constant-Murley Score(CMS) at 3, 6 and 12 weeks, | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | Functional score of the shoulder |
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | Functional score of the shoulder |
| The Disabilities of the Arm, Shoulder and Hand(DASH) Score | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | Functional score of the shoulder |
| Adverse events | From baseline through study completion, an average of 1 year | Adverse events to evaluate the safety |
Countries
China
Contacts
Primary ContactWeiliang Shen, Doctor
Outcome results
None listed