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Clinical Trial Summary

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.


Clinical Trial Description

All injection will be done under ultrasound guidance. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03279796
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Weiliang Shen, Doctor
Phone +86-13757101563
Email wlshen@zju.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2018
Completion date December 31, 2021

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