Clinical trial NCT01856140: Treatment of Tendon Injury Using Mesenchymal Stem Cells
Official title: Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lateral Epicondylitis
Keywords: adipose derived mesenchymal stem cell
allogeneic stem cell
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Collaborating Center, Seoul, Korea
First posted: 2013-05-17
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks
timeFrame: Baseline, 6 weeks, 12 weeks after intervention
Secondary outcomes:
measure: Modified Mayo Clinic Performance Index for the Elbow
timeFrame: Baseline, 6 weeks, 12 weeks after the intervention
measure: Defect Area of Tendon by Ultrasonography in Long Axis
timeFrame: Baseline, 6 weeks, and 12 weeks after the intervention
measure: Defect Area of Tendon by Ultrasonography in Short Axis
timeFrame: Baseline, 6 weeks, and 12 weeks after the intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
Study officials:
affiliation: Seoul National University College of Medicine
name: Sun Gun Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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