Adipose-Derived Stem & Regenerative Cells Reduce Mortality, Improve Renal Function in Preclinical Acute Kidney Injury Study Data Published Today
SAN DIEGO, Oct 05, 2010 (BUSINESS WIRE) -- Preclinical data was published today on research performed by Cytori Therapeutics (NASDAQ:CYTX) showing adipose (fat)-derived stem and regenerative cells (ADRCs), either fresh or banked, demonstrated statistically significant improvements in animal survival and kidney function in an acute kidney injury animal model. Complete results appear in the latest issue of Nephrology Dialysis Transplantation, available for download at ndt.oxfordjournals.org.
Two separate controlled studies were performed. One compared a mixed population of uncultured rodent ADRCs, delivered immediately after extraction (fresh cells), to a control group (n=29; 15 treated: 14 control). The other compared ADRCs, which were cryopreserved and subsequently thawed (banked cells), to a control group (n=19; 10 treated:9 control). ADRCs are comprised of several cell types, including adipose stem cells, endothelial progenitor cells, smooth muscle cells and smooth muscle progenitor cells.
Acute kidney injury was induced by occluding blood flow into and out of both kidneys for 38 minutes. Twenty minutes after reperfusion of the kidneys, 5 x 106 ADRCs or saline only were injected intra-arterially. All rodents were assessed daily for seven days for markers of kidney function (serum creatinine and blood urea nitrogen) and survival.
In the fresh ADRC arm, 100% of the treated group survived after seven days, compared to only 57% of the control group (p = 0.005). In the banked ADRC arm, 90% of the treated group survived after seven days, compared to 33% in the control group (p = 0.019).
The ADRC-treated subjects showed statistically significant improvements in kidney function, as measured by serum creatinine (p<0.0001 in fresh; p<0.05 in banked) and blood urea nitrogen levels (p<0.0001 in fresh, p<0.05 in banked).
In addition, substantial improvement in the histologic structure within the kidney was observed as measured by a reduction in tubular cell death and epithelial shedding (p<0.0001).
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding the ability of ADRC's to improve the survival, function and physiology in an acute kidney injury model in a rodent, are subject to risks and uncertainties that could cause our actual results and financial position to differ. Some of these risks and uncertainties include the challenges inherent in transitioning animal research model to the human therapies, as well as our history of operating losses, regulatory uncertainties, dependence on third party performance, maintaining sufficient capital resources, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Filings, including its annual report on Form 10-K for the year ended December 31, 2009 and subsequent quarterly reports on Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release. |
