A Phase 1/2 interventional study of Autologous adipose tissue stromal vascular fraction and platelet rich plasma in Knee Osteoarthritis, sponsored by University of Science Ho Chi Minh City. Completed at 3 sites in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-22.
Sponsored by University of Science Ho Chi Minh City · Phase 1/2, Interventional, and 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).
4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Science Ho Chi Minh City is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ability and willingness to undergo liposuction
Exclusion Criteria:
Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be injected into joints of 16 patients with grade 2, 3 radiographic OA severity with 16 patients as control.
Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma
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
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Science Ho Chi Minh City