NCT02846675

Safety and Efficacy of Autologous SVF Cells in Treating Patients With Osteoarthritis

A Self-control Study: Safety and Efficacy of Autologous Adipose-Derived SVF Cells Delivered Intra-articularly in Patients With Osteoarthritis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study.

Detailed description

The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo. Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	autologous SVF	SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.
BIOLOGICAL	Placebo	a Placebo treatment without SVF cells

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-07-31
• Completion: 2018-01-31
• First posted: 2016-07-27
• Last updated: 2018-09-11

Locations

1 site across 1 country: China