Wired magazine recently published a feature on Cytori Therapeutics, a regenerative medicine company based in San Diego that is using stem and regenerative stem cells derived from fat (adipose) tissue to repair breasts disfigured by mastectomies and lumpectomies. Cytori‘s technology also has the potential to treat a number of other health conditions, including myocardial infarction and heart disease.
Cytori’s Celution System family of products is designed to harvest stem and regenerative cells from the patient’s fat tissue and combine the cells with a fat graft. Adipose cells are believed to promote healing, and fat tissue is the richest source of stem and regenerative cells in the body, providing a yield 2,500 times greater than that of bone marrow. In nearly a decade of laboratory, animal and human studies, Cytori’s technology has demonstrated the ability to repair heart attack damage, improve function in rodent kidneys damaged by cancer therapy, and reduce urine leakage in men who have undergone prostatectomies. The Celution System improved patient outcomes in the APOLLO and PRECISE European trials in patients with myocardial infarction and heart disease, respectively. And since the stem cells come from the patient’s own body, they’re free of the ethical complications surrounding the use of embryonic stem cells.
According to Wired, breast reconstruction is a strong initial target for Cytori’s technology. The survival rate for breast cancer is increasing in the U.S., leaving numerous patients disfigured from mastectomies and lumpectomies. Only about a quarter of patients get a new breast after having one removed. In addition, patients who undergo lumpectomies are often left with divots in their breasts that surgeons are unable to reconstruct using conventional means.
The U.S. Centers for Disease Control and Prevention estimates that 207,090 new cases of invasive breast cancer and 54,010 new cases of non-invasive breast cancer will be diagnosed in women in the U.S. during 2010. Breast cancer is the most common cancer among American women. Cytori’s first clinical trial of the Celution System began in 2006 and tested the device on 20 breast cancer survivors in Japan. None exhibited an immune response, and 79 percent reported satisfaction with the results. Also critical: the fat wasn’t absorbed back into the body, as tends to occur when fat alone is injected. The company’s Restore 2 trial, conducted in Europe, showed high rates of patient and physician satisfaction at 6 and 12 months. Complete 12-month data is expected in early 2011. Cytori’s Celution System is approved in Europe and Japan for breast reconstruction. The company is in talks with the U.S. Food and Drug Administration about starting a clinical trial.
Life science consulting firm Scientia Advisors forecasts that the global regenerative medicine market will increase from $1.6 billion in 2010 to as much as $20 billion by 2025. With its promising technology platform and clinical trial success, Cytori Therapeutics is a company to watch.