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

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Rotator Cuff Tear; Lateral Epicondylitis

Treatments: Drug: Compound betamethasone; Biological: Autologous adipose-derived MSCs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03279796

2017.No.55

Details and patient eligibility

About

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.

Full description

All injection will be done under ultrasound guidance.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Autologous adipose-derived MSCs

Experimental group

Description:

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.

Treatment:

Biological: Autologous adipose-derived MSCs

Compound betamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Compound betamethasone