Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy and safety of intra-tendon injection of allogeneic adipose-derived mesenchymal stem cells (Allo-ASC) in intractable common extensor tendinosis patients in comparison with a control treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Korea Health Industry Development Institute
• Treatments: Allopurinol; Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

• clinically diagnosed as lateral epicondylosis (tennis elbow)

• symptom duration is over 12 months

• pain visual analogue scale (VAS) during activity ≥ 5

• recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection

• common extensor tendon injury can be observed under ultrasound (hypoechoic lesion) and MRI (hyperintensity or discontinuity)

• patient that can understand the clinical trials

Exclusion Criteria:

• patient that underwent other injection such as steroid injection or prolotherapy within 6 weeks

• patients with following conditions (such as arthritis related to the target lesion, synovitis related to the target lesion, paralysis related to the target lesion, entrapment of related nerve to the target lesion, radiculopathy related to the target lesion, infectious disease, generalized pain syndrome, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or Fibrin Glue, contraindication to MRI)

• patient that enrolled other clinical trials within 30 days

• current pregnancy or breast-feeding, planning for pregnancy

• history of drug/alcohol addiction, habitual smoker

• operation history of affected elbow

• previous clinical trial involving stem cell administration

• other severe medical illness or bleeding tendency

• size of intramural calcification over 2.0 mm under ultrasound evaluation