New study boosts new prospects of world of possibilities for placental-derived cell therapy Print E-mail
By Dusty Garza, BioMedReports   
Monday, 19 August 2013 22:27
The human placenta has been called the “Gift of Life” but for investors, the placenta may give new life to cell therapy holdings. This week, Osiris Therapeutics Inc. (OSIR)s shares more than doubled after the regenerative-tissue company said a trial of its living stem cell treatment closed three times as many diabetic foot ulcers as standard care.  New data from a study showed that its Grafix wound-care product, manufactured from the placenta, proved "overwhelmingly" effective in treating diabetic foot ulcers, paving the way for increased reimbursement from insurers that will boost sales of the therapy.

Interim results from 97 patients in the study found 62 percent of those on Osiris’s Grafix had their wound completely closed compared with 21 percent who received conventional treatment, the Columbia, Maryland-based company said today in a statement. Grafix is a flexible, conforming membrane that is applied directly to wounds. The trial also found the therapy also closed wounds faster.

“Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine,” C. Randal Mills, chief executive officer, said in the statement. “Diabetic foot ulcers afflict 25 percent of all diabetics and are responsible for more hospitalizations than any other diabetic complication.”

One key player in the placental cell therapy space, Pluristem Therapeutics (NASDAQ: PSTI) may be open to joining Osiris in the ring. The Israeli biotechnology firm is harvesting mesenchymal stem cells (MSCs) from human placentas that is the starting material for their PLacental eXpanded (PLX) cells products. PLX cell therapies can be administered as ready-to-use, “off the shelf” treatments that need no matching prior to administration.

Interestingly, the placental-derived MSCs used by Osiris in their Grafix product are the same MSCs used by Pluristem as their cell source to produce PLX cells. Presently, the company is in Phase I or II clinical trials in the areas of Peripheral Artery Disease (critical limb ischemia and intermittent claudication) and Muscle Injuries (adjuvant hip replacement and athletic injuries).  Pluristem CEO Zami Aberman told Fast Company that the MSCs cells obtained from "one placenta can help treat 10,000 people." 

Pluristem is at a clear advantage, first, because the Company is not relying on any contract manufacturer. Under the procedures and protocols that it has pioneered, it is able to modulate the performance of its PLX cells for specific indications by modifying and optimizing the conditions under which they are expanded. In other words, it can modify what the cells do.

Second, placental cells are easily obtainable, and they are particularly amenable to expansion. Collecting placentas is not inconvenient to donors. Pluristem also seems to be particularly adept at finding ways to fund the various indications it is exploring as potential indications. It is also studying exactly what the cells do to better understand how they function, which could help guide the company to new indications.

Given the great results from the recent Osiris study, the company may be open to jumping into the diabetic foot ulcer area since Pluristem has access to the abundant supply of viable, multi-potent MSCs, fibroblasts and epithelial cells would needed to make the wound-care matrix say officials of the company.

No doubt that small-cap companies such as Pluristem want to get into the ring with Osiris Therapeutics. There are profits to be made in the area--approximately $30 billion is spent annually in the therapeutic and regenerative cellular market.

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