ABSTRACT
BACKGROUND: Stromal vascular fraction (SVF) therapy has been performed over the past six years to treat 421 patients by our group in five clinical centers. Autologous SVF, which is a substance containing stem cells, was isolated from lipoaspirate, mixed with platelet-rich plasma (PRP), and administered to patients with degenerative diseases, autoimmune diseases, trauma, aging, and other diseases with unknown etiology. This study aimed to determine the safety of SVF and PRP that were given through infusion, spinal, and intra-articular injection. METHODS: The lipoaspirate was treated with a tissue-dissociating enzyme, and then, through centrifugation, SVF was isolated. In addition, blood was drawn from each patient, and PRP was isolated. Autologous PRP and SVF were administered to all subjects by intravenous (IV) injection. A minority group within the population received an additional spinal or intra-articular injection. The type of intervention was determined by each disease evaluation. The cell doses and adverse events for each patient were documented and analyzed. RESULTS: Cell dose that was considered to be safe was less than 10 billion SVF cells in 250 cc of normal saline, for IV injection, and less than 1 billion SVF, for intra-articular and spinal injection. Adverse events were not severe and were treated successfully. Any observed adverse events were identified as a result of spinal or intra-articular injections and were not related to SVF or PRP. CONCLUSIONS: Our results showed that administration of high dose of SVF until 10 billion cells in a majority of 421 patients through infusion, spinal, and intra-articular injection was feasible without causing major adverse events and should be further investigated in well-designed phase I-II clinical trial to address the safety and efficacy of therapy.
ABSTRACT
BACKGROUND: Adipose-derived stem cells (ADSCs) improve wound healing owing to their angiogenic potency. However, the production of large quantities of ADSCs for clinical applications is laborious. In this study, the efficacy of the stromal vascular fraction (SVF; non-expanded ADSCs) combined with platelet-rich plasma (PRP) which contains abundant growth factors, for wound healing was evaluated using an animal model. METHODS: PRP from venous blood and SVF from lipoaspirates were harvested from six donors. PRP, SVF, SVF + PRP, and saline solution as a negative control were injected to second degree burn wounds in the backs of 24 male Sprague-Dawley rats. On the seventh day after injection, rats were euthanized and wounds were analyzed microscopically and macroscopically. RESULTS: Wounds closed faster in the SVF + PRP group than in the control group or PRP or SVF alone groups, with less inflammation, prominent signs of re-epithelization, more skin appendages and blood vessels, and a higher rate of hair growth. No infection or rat death occurred during the trial. CONCLUSIONS: The combination of SVF and PRP may provide an additive stimulatory effect to support angiogenesis and accelerate the wound healing process; accordingly, this combination is a potential alternative to ADSC treatment.
