The National Institutes of Health is planning to conduct phase 1 and 2 clinical research trials in humans to test novel therapies to help block organ rejection without the use of immunosuppression.
The trials will test monoclonal antibodies and other therapies for potential use in the transplantation of kidneys and the transplantation of pancreatic islet cells. Recruitment of adult volunteers with type 1 diabetes or kidney failure is expected to begin early in the summer.
In 1997, Allan D. Kirk, MD, PhD, and colleagues at the Naval Medical Research Center reported on a therapy that was capable of preventing the rejection of mismatched kidneys transplanted into rhesus monkeys (see Transplant News Network, October 15, 1997). "This therapy appears to prevent rejection of transplants without totally suppressing immune system function and is ready for testing in human clinical trials," the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) said in a statement (www.niddk.nih.gov/new/newsbref/novelpha.htm).
The clinical research protocols will be developed by a new Navy-NIDDK Transplantation and Autoimmunity Research Branch. The NIDDK and the Navy research center will collaborate on the new trials with other government centers and the Diabetes Research Institute of the University of Miami.
"The novel therapies to be tested could potentially make transplantation of islets more widely available for patients with type 1 diabetes and could also eliminate the need for immunosuppressive drugs such as steroids and cyclosporine now required to sustain transplanted organs such as kidneys," the NIDDK said.
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