Treatment of Tendon Injury Using Mesenchymal Stem Cells (ALLO-ASC)

Seoul National University

Status and phase

Completed

Early Phase 1

Conditions

Lateral Epicondylitis

Treatments

Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01856140

SNUH-RM-SGChung-ASC-01

Details and patient eligibility

About

Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.

Full description

Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants).

The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.

Enrollment

12 patients

Sex

All

Ages

19 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

clinically diagnosed as lateral epicondylitis (tennis elbow)
recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
symptom duration is over 6 months
defect in common extensor tendon can be observed under ultrasound
patient that can understand the clinical trials

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 30 days
history of drug/alcohol addiction, habitual smoker