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).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
115 Hospital, Ho Chi Minh city
Ho Chi Minh City, Vietnam
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
Ho Chi Minh City, Vietnam
Van Hanh Hospital, Ho Chi Minh city, VN
Ho Chi Minh City, Vietnam
Number of participants with adverse events
Time frame: 6 months
Change from the baseline pain score (VAS) at 6 months
Time frame: 6 months, 12 months, 18 months
Change from baseline Lysholm score at 6 months
Time frame: 6 months, 12 months, 18 months
Change from baseline MRI assessment
Time frame: 12 months
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