Collaborative Study Shows that Stem Cells Can Replace Powerful Anti-Rejection Drug

DRI Scientific Director Dr. Camillo Ricordi says the worldwide collaborative strategy has resulted in another step forward in our cure-focused efforts.

Miami, FL – March 20, 2012, 3:00PM (CDT) — New findings from a transplant study led by scientists from the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine and a DRI Federation center at Xiamen University in China showed that mesenchymal stem cells may replace a powerful anti-rejection drug in transplant recipients. The results of this pioneering study involving kidney transplant patients is published in the March 21 issue of the Journal of the American Medical Association (JAMA) and may fundamentally transform the future of clinical transplantation.   

Patients undergoing a transplant routinely receive a regimen of immunosuppressive therapy to block the body’s immune system from rejecting the donor organ or cells. While these drugs have been shown to improve graft function and minimize rejection episodes, they increase the risk of dangerous side effects, including infections and organ toxicity. To eliminate these adverse effects, scientists at the Diabetes Research Institute and collaborating centers worldwide have been investigating safer methods for preventing transplant rejection and have turned their attention to naturally-occurring cells in the body that have immuno-modulatory properties, like mesenchymal stem cells.  

Researchers are investigating mesenchymal stem cells, among other naturally-occurring cells, for the many therapeutic benefits.

A mesenchymal stem cell (MSC) is a type of cell that can differentiate into bone, cartilage, fat and other body tissues. But MSCs have also been found to have a number of other beneficial therapeutic properties, including their ability to modulate the immune system by inhibiting T-cell proliferation, eliminating graft-vs.-host disease, limiting cytotoxic inflammation and stimulating vascularization, among other benefits. 

“This study represents a first, important step toward the definition of cell-based strategies that will one day allow for transplantation without the need for life-long, anti-rejection drugs,” said Camillo Ricordi, M.D., director of the University of Miami Diabetes Research Institute and Cell Transplant Center. “The worldwide collaborative strategy of the Diabetes Research Institute Federation and The Cure Alliance has resulted in yet another small step forward in our worldwide cure-focused efforts, indicating safety and efficacy of a stem cell-based strategy toward reducing and eventually eliminating anti-rejection drugs. This is particularly important to the DRI mission, as transplantation without

Dr. Antonello Pileggi
Dr. Antonello Pileggi says that MSCs may be valuable for improving transplantation outcomes while reducing risks for patients.

immunosuppression is a major goal in any strategy for transplantation of insulin producing cells and a requirement for becoming a reality for all patients with Type 1 or Type 2 insulin dependent diabetes.”  

In this recent study, “Induction Therapy with Autologous Mesenchymal Stem Cells in Living-Related Kidney Transplants,” patients with end-stage renal disease received infusions of bone-marrow derived autologous mesenchymal stem cells together with either standard-dose or low-dose calcineurin inhibitors (CNI). The control group received an immunosuppression regimen consisting of anti-IL-2 receptor antibody plus standard-dose CNI. 

After one year post-transplant, the results of the study indicate that among the patients undergoing a kidney transplant, the use of autologous MSCs compared with the standard immunosuppressive therapy resulted in lower incidence of acute organ rejection, decreased risk of infection and better kidney function.

The study was conducted together with Diabetes Research Institute Federation partners in China.

“We reported on the first 12 months follow-up, which showed no adverse events associated with MSC therapy.  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 MSCs transplantation in this setting.  Should long-term safety of MSCs be confirmed, it may be valuable for improving transplantation outcomes while reducing the risks associated with anti-rejection drugs,” said Antonello Pileggi, M.D., Ph.D., director of Preclinical Cell Processing and Translational Models Program at the Cell Transplant Center of the DRI. 

“This collaboration was part of the ongoing global efforts of The Diabetes Research Institute Federation and of The Cure Focus Research Alliance. The opportunity to contribute these results obtained through the combined team efforts of Affiliated Fuzhou General Hospital of Xiamen University and DRI to a journal as high impact as JAMA represents an important achievement for the China-USA Collaborative Human Cell Transplant Program at the Cell Transplant Center of DRI,” said Xiumin Xu, M.S., director of the China-US Collaborative Human Cell Transplant Program at the Diabetes Research Institute. 

About the Diabetes Research Institute 
The Diabetes Research Institute at the University of Miami Miller School of Medicine leads the world in cure-focused research. As the largest and most comprehensive research center dedicated to curing diabetes, the DRI is aggressively working to shrink the timeline toward the discovery of a biological cure for this disease.  Having already shown that diabetes can be reversed through islet transplantation, the DRI is building upon these promising outcomes by bridging cell-based therapies with emerging technologies. The Diabetes Research Institute was created for one reason – to cure diabetes – which is and will continue to be its singular focus until that goal is reached. For the millions of people affected by diabetes, the DRI is the best hope for a cure. 

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Lori Weintraub 

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