For the past couple of years, various modes of first generation adult stem cell therapy for heart disease have been trialed - mostly outside the US prior to 2004, thanks to the heavy, unaccountable, keep-my-own-job-safe hand of the FDA. These are comparatively simple therapies; forms of transplant using either donor stem cells, usually from bone marrow, or cultured stem cells from the patient to avoid immune rejection. An update on one of the latest trials:
Two patients have already been enrolled at Hopkins in a Phase I clinical trial, which is designed to test the safety of injecting adult stem cells at varying doses in patients who have recently suffered a heart attack. In total, 48 patients will participate in this study, which is happening at several sites across the country. Results are not expected until mid-2006.
The researchers are using a special kind of stem cell in an early stage of development, called adult mesenchymal stem cells, to avoid potential problems with immunosuppression, in which every human's immune system might attack stem cells from sources other than itself.
This trial uses cells from sources other than the patient, and performed very well in animal studies. If regulatory matters and commercialization proceed at the normal pace for the US medical system, some form of effective stem cell therapy for heart disease should be a widely available option by 2010.