Stem cells provided by San Diego-based Stemedica Cell Technologies Inc. are expected to be used soon in a phase I/II clinical trial for chronic heart failure in Mexico.
Stemedica announced May 29 that its strategic Mexico partner, Grupo Angeles Health Services, has received approval for a single-blind randomized clinical trial from Mexicos FDA equivalent regulatory agency, COFEPRIS.
The trial being conducted at multiple hospital sites throughout Mexico will involve Stemedicas adult allogeneic ischemia tolerant mesenchymal stem cells 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 trial, set to begin on or before July 1 with 60 to 80 patients, is one of only two studies using allogeneic stem cells approved by COFEPRIS. The other study approved in 2010 was a clinical trial for ischemic stroke.
We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedicas product for this indication, said Stemedica CEO Maynard Howe in a statement. 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.
Grupo Angeles, comprised of 24 state-of-the-art hospitals, conducts some 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.
Stemedica stem cells are also currently being used in a phase I/IIa trial for stroke patients at UC San Diego. The 36-patient clinical trial has been progressing about a year and is moving into its third and final cohort, said Dave McGuigan, vice president of marketing and business development for the company. When patient treatments are completed by the end of September, data will be evaluated to determine whether it moves to a full phase IIb trial to primarily determine efficacy in a larger population of 60 to 80 patients, McGuigan said.
Our next step would be to initiate a phase II clinical trial in multiple sites across the U.S. in 2013, he said.
Founded seven years ago, the privately held Stemedica specialty biopharmaceutical company has about 46 locally based employees in the U.S. and an additional eight staff in Switzerland, South Korea and Singapore.