One-year clinical trial data indicates that MSC infusions are safer than immunosuppressants.

Data from an early clinical trial indicate that giving kidney transplant patients autologous transplants of mesenchymal stem cells (MSCs) may negate the need for drug-based immunosuppression. The study, reported in JAMA, has been carried out by researchers at the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine, and a DRI Federation center at Xiamen University in China.

In the reported trial, end-stage renal disease patients were given infusions of bone-marrow-derived autologous mesenchymal stem cells together with standard-, or low-dose calcineurin inhibitors (CNI). A control group of patients received immunosuppression comprising anti-IL-2 receptor antibody plus standard-dose CNI. Data one year post transplant demonstrated that in comparison with patients receiving standard immunosuppressive therapy, those receiving autologous MSCs demonstrated a lower incidence of acute organ rejection, decreased risk of infection, and better kidney function. There were in addition no adverse events associated with MSC therapy. The published paper describing the results is titled “Induction Therapy with Autologous Mesenchymal Stem Cells in Living-Related Kidney Transplants.”

The DRI maintains the study represents a first and important step toward the goal of developing cell-based strategies that could negate the need for life-long anti-rejection drugs. “We will continue monitoring the patients in the study to assess the long-term effects on kidney transplant function and survival, as well as the safety of MSC transplantation in this setting,” comments Antonello Pileggi, M.D., director of preclinical cell processing and translation models program at the DRI’s Cell Transplant Center. “Should long-term safety of MSCs be confirmed, it may be valuable or improving transplantation outcomes while reducing the risks associated with anti-rejection drugs.”

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