Critical limb ischemia is an advanced form of peripheral artery disease that causes hundreds of thousands of amputations per year. This condition is attractive to stem cell intervention because even a marginal improvement in circulation may be enough to prevent amputation. Previous work from Japan and Mike Murphy’s group at Indiana has demonstrated that use of patient’s bone marrow stem cells can effectively reduce ulcers and increase circulation.
Today the Ohio company Arteriocyte has received approval from the U.S. Food and Drug Administration to begin a Phase 1 clinical trial for the treatment of critical limb ischemia. The clinical trial will investigate the use of Arteriocyte’s Magellan device. The device concentrates stem cells and blood platelets during surgeries. These concentrated cells can be injected into patients, boosting the body’s ability to repair itself. The device is already used in about 6,000 surgeries per month, according to the company.
In addition to critical limb ischemia, Arteriocyte plans to begin clinical trials assessing Magellan’s ability to treat cardiovascular disease, and the clinical setting of orthopedics and tissue repair during 2011, according to the statement.
Arteriocyte CEO Don Brown stated “The synergy that the Magellan technology brings to our core efforts is a device that enables rapid bedside processing of tissue — blood or bone marrow — that delivers back to the surgeon a concentrated injectate of those cells for use as the surgeon deems appropriate.”
Other approaches to treatment of critical limb ischemia include the use of “universal donor” stem cells. These have an advantage in the sense that bone marrow does not need to be harvested from the patient that is being treated. In contrast, stem cells are extracted from healthy donors, expanded in tissue culture, and sold as a “stem cell drug.” This is the approach that Medistem is pursuing with its Endometrial Regenerative Cells. Other companies working on universal donor stem cells for critical limb ischemia include Pluristem, which derives its stem cells from the placenta and expands them using a proprietary bioreactor.
Universal donor stem cells from the bone marrow are currently being developed by Athersys, Osiris, and Allocure.
Currently the most advanced critical limb ischemia clinical trials are from the companies Harvest and Bio-Met, which also have devices. The company Aastrom is also involved in critical limb ischemia, they are using a bioreactor to expand patient’s own bone marrow derived stem cells. Aldagen is also using bone marrow derived stem cells for critical limb ischemia, these ones are purified on the basis of aldehyde dehydrogenase expression.