Adipose Stem & Regenerative Cell Clinical Study Underway For Treatment Of Chronic Radiation Injury

Main Category: Radiology / Nuclear Medicine
Also Included In: Cancer / Oncology;  Stem Cell Research
Article Date: 01 Jan 2009 - 4:00 PDT

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Cytori (NASDAQ: CYTX) announced that the first patient was enrolled in an investigator-initiated study using adipose-derived stem and regenerative cells to treat the chronic effects of radiation-induced local tissue injury. The 30-patient study is being conducted independently by Nagasaki University Hospital in Japan. Cytori's Celution® 800 System is being used to process and extract patients' own adipose tissue-derived stem and regenerative cells.

Radiation-related tissue injury, poor wound healing, and deep skin ulcers are among the serious effects of cancer therapy and may also occur from exposure to nuclear materials. "Currently, few treatment options exist for these patients," said Dr. Sadinori Akita, assistant professor of surgery at Nagasaki University and principal investigator of the study. "Based on the early result of the first case and the more than 300 various clinical cases performed to date using the Celution 800 System output, we believe Cytori's regenerative medicine technology has the potential to become a standard of care for a very large group of patients with injuries resulting from radiation exposure."

The study is being funded from a portion of a five year, $15 million grant awarded to Nagasaki University by the Ministry of Education, Sports, and Culture of Japan. The University is also home to the Global Strategic Center for Radiation Health Risk Control, an international consortium on radiation and atomic bomb injury research and medicine (www-sdc.med.nagasaki-u.ac.jp/gcoe/index.html). The Center emerged in the recovery from the historical atomic disaster suffered by Nagasaki, and is aligned with the World Health Organization (WHO), the International Atomic Energy Commission (IAEC) and the International Agency for Research on Cancer (IARC).

Nagasaki University is sponsoring one of several independent, investigator-initiated clinical studies, which are expected to begin around the world in 2008 and 2009 using Cytori's Celution® 800 System. "This study is important to Cytori," said Marc H. Hedrick, M.D., president of Cytori. "Our Celution® System will be used by a worldwide leader in radiation damage research and creating potential opportunities for Cytori to work more closely with the WHO and IARC. Ultimately these relationships in combination with a successful study could result in the Celution® System becoming a standard therapy for radiation-related disease."

About Cytori

Cytori's (NASDAQ: CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. The Celution® 800 System is being introduced in Europe into the reconstructive surgery market while the Celution® 900 System is being commercialized globally for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.