In the preclinical rodent study, donor adipose-derived stem and regenerative cells, or saline, was combined with donor adipose tissue and then transplanted onto recipient skulls. After six and nine months, grafts were harvested and weighed. The mean weight of cell-enhanced grafts at six and nine months was two times greater than grafts with saline (p = 0.019 at six months; p=0.034 at nine months). Histological analysis revealed the cell-enhanced grafts contained less fibrous tissue, suggesting improved graft quality. Additionally, donor stem and regenerative cells were present within grafted adipose tissue and were incorporated into blood vessel walls within the fat graft.
A related preclinical study further established safety of adipose-derived stem and regenerative cells by demonstrating these cells had no effect on the promotion of tumor growth. Human fat grafts with or without adipose-derived stem and regenerative cells were transplanted onto mammary fad pads of rodent recipients injected with human breast cancer cells. The study was repeated with three human fat donors. After eight weeks, the study found no evidence that enhancing the fat graft of any of the donors with stem and regenerative cells had any effect on the in vivo growth rate, volume, or metastasis of the human breast tumors.
Marc Hedrick, president of Cytori Therapeutics, said: “Using Cytori’s Celution System to provide stem and regenerative cells would simplify, standardize and improve the predictability of shape and volume outcomes for fat transfer procedures, including breast reconstruction following partial mastectomy.”