ATHX has completed patient enrollment of a Ph I clinical trial of MultiStem®, its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. Top line results of the trial are expected to be announced mid-year, upon completion of a 4 month patient follow-up visits and analysis of results. The Ph I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of a single administration of allogeneic MultiStem cells. Myocardial infarction remains one of the leading causes of death and disability in the US.
Following standard treatment, enrolled patients receive MultiStem delivered via a catheter that enables rapid and efficient delivery into the damaged region of the heart. The study is being conducted at multiple US cardiovascular treatment centers, including the Cleveland Clinic, Columbia University Medical Center and Henry Ford Health System and includes patients in 3 treatment cohorts or dose groups as well as a non-treated registry group.
In preclinical studies conducted by ATHX and independent cardiovascular research teams, administration of MultiStem following an ischemic injury to the heart has been associated with a number of benefits, including an increase in ejection fraction, or volume of blood pumped from the heart, a reduction of inflammation in the region of ischemic injury and increased angiogenesis, each believed to help augment recovery and healing.
- Athersys’ MultiStem® is a patented and proprietary cell therapy product consisting of a special class of stem cells that are obtained from the bone marrow or other tissue sources of healthy, consenting adult donors and have the demonstrated ability to produce a range of factors, as well as form multiple cell types,
- MultiStem® appears to promote tissue repair and healing in multiple ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage,
- MultiStem® could represent a unique “off-the-shelf” stem cell product based on work that demonstrates the ability to deliver multiple mechanisms of therapeutic benefit, administration of the product without tissue matching or immunosuppression, and its capacity for large-scale production,
- Reiterating, Athersys has a strategic partnership with Pfizer (NYSE:PFE) to develop MultiStem for inflammatory bowel disease (NYSEARCA:IBD) and with Angiotech to develop MultiStem in AMI and other cardiovascular indications.