Stemedica Cell Technologies, Inc. announced today that its strategic partner in Mexico, Grupo Angeles Health Services, has received approval from Mexico’s regulatory agency, COFEPRIS, for a Phase I/II single-blind randomized clinical trial for chronic heart failure. COFEPRIS is the Mexican equivalent of the United States FDA. The clinical trial, to be conducted at multiple hospital sites throughout Mexico, will utilize Stemedica’s adult allogeneic ischemia tolerant mesenchymal stem cells (itMSC) delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage. The COFEPRIS approval is the second approval for the use of Stemedica’s itMSCs. COFEPRIS approved Stemedica’s itMSCs in 2010 for a clinical trial for ischemic stroke. These two trials are the only allogeneic stem cell studies approved by COFEPRIS.
Grupo Angeles is a Mexican company that is 100% integrated into the national healthcare development effort. The company is comprised of 24 state-of-the-art hospitals totaling more than 2,000 beds and 200 operating rooms. Eleven thousand Groupo Angeles physicians annually treat nearly five million patients a year. Of these, more than two million are seen as in-patients. In just over two decades, Groupo Angeles has radically transformed the practice of private medicine in Mexico and contributed decisively to reform in the country’s health system. Grupo Angeles hospitals conduct an estimated 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.
“We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedica’s product for this indication. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer from this condition,” said Maynard Howe, PhD, CEO of Stemedica Cell Technologies, Inc.
Roberto Simón, MD, CEO of Grupo Angeles Health Services, noted, “We are proud to be the first organization to bring regulatory-approved allogeneic stem cell treatment to the people of Mexico. We envision that this type of treatment may well become a standard for improving cardiac status for chronic heart failure patients and are pleased to be partnering with Stemedica, one of the leading companies in the field of regenerative medicine.”
Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica commented, “For the more than five million North Americans who suffer from chronic heart failure, this is an important trial. Our ischemia tolerant mesenchymal stem cells hold the potential to improve ejection fraction—the amount of blood pumped with each heart beat—and therefore, dramatically improve quality of life.”