Knee Osteoarthritis Clinical Trial
Official title:
Phase I/II Study of Transplantation of Autologous Adipose Stem Cells and Activated Platelet Rich Plasma in Knee Osteoarthritis Treatment
Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.
The proposed study is two centers, unblinded, non randomized, phase I/II trial in which the
patients will be treated with a single dose of autologous stromal vascular cells (SVF) in
combination with platelet rich plasma (PRP).
This study aimes to evaluate the clinical efficiency of autologous adipose tissue-derived
MSC transplantation in patients with confirmed osteoarthritis at grade II and III. Adipose
tissue is isolated from the belly, and used for extraction of the SVF. The SVF is mixed with
activated platelet-rich plasma before injection. The clinical efficiencies are evaluated by
the pain score (VAS), Lysholm score, and MRI findings. SVF is isolated from about 100 mL of
adipose tissue, and PRP is prepared from 20 mL of peripheral blood. Total injection volume
will be about 5-10 mL. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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