DEERFIELD, Ill.--(BUSINESS WIRE)-- <\/p>\n
Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual\u2019s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI). <\/p>\n
Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions. <\/p>\n
\u201cThe prospect of using a person\u2019s own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach,\u201d said Norbert Riedel, Ph.D., Baxter\u2019s chief science and innovation officer. \u201cThe goals of this phase III trial are aligned with Baxter\u2019s overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.\u201d <\/p>\n
The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment. Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells. <\/p>\n
After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue. Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Stem cell processing will be conducted in GMP facilities in the United States by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. To learn more or enroll, visit http:\/\/www.renewstudy.com<\/a> or http:\/\/www.clinicaltrials.gov<\/a>. <\/p>\n This trial is being initiated based on the phase II data, which indicated that injections of patients\u2019 own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina. <\/p>\n \u201cThe phase II trial provided evidence that this strategy, leveraging the body\u2019s own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options,\u201d said Douglas Losordo, MD, vice president of new therapeutic development at Baxter. <\/p>\n CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia. <\/p>\n About Baxter <\/p>\n Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. <\/p>\n This release includes forward-looking statements concerning the use of adult autologous stem cells to treat CMI, including expectations with respect to the related phase III clinical trial. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical results demonstrating the safety and effectiveness of the use of autologous stem cells to treat CMI; timely submission of regulatory filings; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; the enrollment of a sufficient number of qualified participants in the phase III clinical trial; the successful provision of stem cell processing by PCT, a third party; and other risks identified in Baxter\u2019s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter\u2019s website. Baxter does not undertake to update its forward-looking statements. <\/p>\n Photos\/Multimedia Gallery Available: http:\/\/www.businesswire.com\/cgi-bin\/mmg.cgi?eid=50183372&lang=en<\/a> <\/p>\n MULTIMEDIA AVAILABLE:http:\/\/www.businesswire.com\/cgi-bin\/mmg.cgi?eid=50183372&lang=en<\/a> <\/p>\n<\/p>\n Read more from the original source: DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual\u2019s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI). Continue reading
\nBaxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"