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Approval granted for adipose tissue study to evaluate use in breast reconstruction

San Diego/Tokyo — Cytori Therapeutics Inc., based here, has obtained approval to begin a safety and feasibility study in Japan using adult adipose derived stem and regenerative cells for breast reconstruction.

The study has been approved by the Institutional Review Board and the first patient has been already been enrolled.

The study was initiated and will be conducted by Keizo Sugimachi, M.D., president of Kyushu Central Hospital in Fukuoka, Japan, in conjunction with Cytori. The study will employ the company’s Celution system to isolate and concentrate patients’ stem and regenerative cells. This is the first Celution system to be installed in Asia and utilized in a clinical study.

While early detection has increase the number of women eligible for partial mastectomy, this approach, though effective in the treatment of breast cancer, can often result in significant skin damage and tissue loss, says a Cytori spokesman, adding that there is a clinical need for treatments that restore the soft tissue and that it’s believed stem-cell therapies may play an important role in this area in the future. Adipose tissue, the spokesman says, is a rich source for stem and other regenerative cells that are believed to contribute to repair and healing.

The study will enroll as many as 20 breast-cancer patients who have undergone a partial mastectomy. In addition to safety, the study will evaluate volume retention as well as other outcomes of reconstructive surgery. Each patient will have a small volume of tissue removed from one or more of the body’s normal fatty depots, and it will be delivered to the affected areas of the breast and subcutaneous tissue.
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