Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells
Status:
Not yet recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University