Jewish Hospital, Kleinert Kutz Hand Care Center, Christine M. Kleinert Institute and University of Louisville will use cell-based therapy to reduce hand transplant rejection

The Louisville Vascularized Composite Allograft (VCA) program, a partnership of physicians, researchers and healthcare providers from Jewish Hospital, part of KentuckyOne Health; the Christine M. Kleinert Institute for Hand and Microsurgery (CMKI); the Kleinert Kutz Hand Care Center; and the University of Louisville, has been awarded $850,000 to fund a clinical trial of a new treatment that will help prevent rejection of hand transplants.

The funding comes as part of the Armed Forces Institute of Regenerative Medicine (AFIRM) research program. AFIRM II is a five-year, $75 million federally-funded project that will focus on applying regenerative medicine to battlefield injuries.
The group developed the pioneering hand transplant procedure and has performed nine hand transplants on eight patients since 1999. The clinical trial will be led by primary investigator Joseph Kutz, M.D., partner with Kleinert Kutz Hand Care Center, and will take place at Jewish Hospital and Kleinert Kutz Hand Care Center with research taking place at the CMKI and the Cardiovascular Innovation Institute, a partnership of Jewish Hospital and the University of Louisville.

While Composite Tissue Allotransplantation (CTA) is a viable option for soldiers with combat-related catastrophic tissue loss of the hands, an obstacle to successful hand transplantation is the need for lifelong immunosuppression drugs. The AFIRM II funding will enable Louisville VCA researchers to explore the potential for a cell-based therapy to improve the immune system’s response to a hand transplant, and ultimately lessen or eliminate the need for immune-suppressant drugs. Results of this trial will be far-reaching and benefit not only military patients, but all hand transplant recipients.

“Many soldiers who could benefit from a hand transplant are in their 20s, and would need 50 or more years of medication to prevent rejection,” said Dr. Kutz. “This new treatment of stromal and vascular fraction (SVF) cell therapy could mitigate or eliminate the complications brought on by lifelong immunosuppression, giving more soldiers the option of hand transplant who may not have been candidates before.”

“Nearly all hand transplant patients experience some degree of rejection, so the need for our research is great. Receiving our first federal AFIRM grant will enable Jewish Hospital, CMKI and the University of Louisville to be at the forefront of research to advance the field of hand transplantation,” said Michael Marvin, M.D., director of transplantation at Jewish Hospital, associate professor of Surgery at the University of Louisville, and a collaborating investigator on the new trial.

Regenerative medicine takes advantage of the body’s natural healing powers to restore or replace damaged tissue and organs. In the Louisville VCA trial, cells from adipose (white fat) tissue will be isolated from the transplant patient and injected into the hand transplant graft. These SVF cells have been shown to reduce inflammation and activate immune responses. Researchers believe that the injection of these cells into transplant recipients will dramatically reduce rates of rejection, as well as the need for anti-rejection drugs. One to two transplant recipients each year for five years will be enrolled in the trial.

“Investigators at the Cardiovascular Innovation Institute are excited to join an incredible team of investigators to advance clinical implementation of regenerative medicine therapies,” said Stuart K. Williams, II, Ph.D., executive and scientific director, Cardiovascular Innovation Institute.

“This funding is a fantastic opportunity for the Louisville VCA Program. The mission of AFIRM II is to accelerate solutions to treat battlefield injuries. We are honored to be able to contribute to that mission. In addition it highlights to the world the unique collaboration we have in Louisville, and allows us to share our results and advances with other cutting edge teams within the consortium. It also positions our program for additional clinical trial funding in the future. I could not be more thrilled about this award.” said Christina L. Kaufman, Ph.D., executive director of the CMKI and a collaborating investigator on the AFIRM II-funded clinical trial.

The first phase of AFIRM, which began in 2008, resulted in clinical studies of face transplantation, minimally invasive surgery for craniofacial injuries, a lower-dose anti-rejection regimen after kidney transplantation, scar reduction treatments, fat grafting for reconstructive surgery and new treatments for burns. AFIRM II will focus on clinical trials involving restoration of function to severely traumatized limbs; reconstruction for facial and skull injuries through tissue regeneration; skin regeneration for burn injuries; new treatments to prevent rejection of “composite” transplants such as face and hands; and reconstruction of the genital and urinary organs and lower abdomen.