Pluristem Therapeutics said early clinical trials show its placenta-derived cell therapy is safe and improves quality of life in patients with peripheral artery disease, or PAD.

PAD is an obstruction of blood vessels, usually in the leg, causing pain, difficulty in walking and leading eventually to amputation.

The Phase I trials, conducted at three university hospitals in the United States and one in Berlin, show the cells are effective in treating the end stage of PAD, called critical limb ischemia, the Israel-based biotech company said on Tuesday.

Pluristem plans advanced trials in the first half of 2011.

Unlike many other companies that use embryonic stem cells, Pluristem harvests cells from the placenta after a woman gives birth, so there is no ethical issue on using embryos.

“We have proved we can use the placenta as a source for a product that doesn’t require a match between the donor and patient,” Chief Executive Zami Aberman told Reuters.

While an estimated 20 million people in the United States suffer from PAD, Pluristem is targeting the 2.5 million who are in the end stage. Insurance companies pay about $10 billion a year to treat those patients.

Pluristem estimates it can slash reimbursement costs of insurance companies by about 50 percent, as the cost of treating PAD using its therapy, called PLX-PAD, is significantly cheaper than current methods, which run to around $40,000 per year.

Present treatment for PAD include a bypass to improve circulation, drugs to improve bloodstream and oxygen chambers.

“These can stop progress of the disease for a while but do not change the situation,” Aberman said.

Pluristem’s clinical trials showed patients experienced improvement in bloodstream, pain and quality of life for six months following a 20-minute session of injections.

“The most important thing is to reduce the amputation rate,” Aberman said. “What we envision is a treatment once in six months.”

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By Tova Cohen

TEL AVIV (Reuters)