The mesenchymal stem-cell company Osiris has announced positive results of its two-year 53-patient trial in heart disease. According to the press release,
patients receiving Osiris’s product Prochymmal had fewer arrhythmias. About 12% of treated patients had arrhythmias compared to 47% of those receiving a placebo treatment. (Even though the press release reports percents, remember that there are less than 100 patients in the trial). Osiris also reported no immune-related side effects. That’s significant, because unlike other adult stem cell therapies which return a patient’s own cells back into the patient, Osiris uses cells collected from the bone marrow of healthy donors. (But see a cautionary report from a mouse study)
A recent article in Nature Biotechnology (subscription required) describes the $1.38 billion dollar deal ($130 million upfront) that Genzyme made with Osiris for its mesenchymal stem cell technology. These cells are thought to secrete factors that help the heart heal itself.
Osiris is planning a 220-patient phase II trial for patients that have experienced a single heart attack. According to the company, “efficacy endpoints determined from cardiac MRI include end systolic volume, LVEF and the ability of Prochymal to preserve functional heart tissue, or limit scar formation following a heart attack. In addition, functional and quality of life assessments will be performed.”
This is one of several approaches to using stem cells in the heart. We covered these in a feature last year:
Stem cells for the heart, a new wave of clinical trials Also see a review by Andre Terzic on how stem cells can be used in regenerative medicine that just came out this month.
Just last week, researchers announced plans to launch a clinical trial testing another approach. That will biopsy heart tissue from heart attack patients, extract stem cells from it and reinject the stem cells into the scarred areas of the heart. This was written about in BusinessFirst of Louisville, Kentucky.