NCT01856140

Treatment of Tendon Injury Using Mesenchymal Stem Cells

Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lateral Epicondylitis

Interventions

Type	Name	Description
BIOLOGICAL	ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-07-01
• Completion: 2018-04-01
• First posted: 2013-05-17
• Last updated: 2022-03-18
• Results posted: 2022-02-18

Locations

1 site across 1 country: South Korea