Accumulating clinical and preclinical trials are adding to the database, supporting the idea that human cell therapy with MSC transplantation is a safe and a reliable procedure for treating heart disease. Long-term rigorous patient monitoring demonstrates the durability and safety of cell-based therapies for heart disease, with no incidence of tumorigenesis. As with any new therapy, extreme vigilance is required to monitor for, manage, and understand the risk of unwanted and desirable side effects. The specter of neoplasia raises major concerns. However, we conclude that the observations in rodent animal models used to study human diseases should be interpreted with caution when assessing safety and efficacy of any new therapeutic modality and that the risk- benefit profile of MSC cell therapy in the rodent is substantially different from that in large mammals. We believe that ongoing trials of MSCs in humans are of acceptable risk, but strongly argue for ongoing vigilance, particularly over the long term.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine