University of Minnesota researchers have initiated a ground breaking clinical trial to determine the optimal dose and safety of T regulatory cells (T-regs) to decrease the risk of immune reactions common in patients undergoing blood and marrow transplantation.
Ultimately, the researchers hope the experimental cellular therapy will improve overall survival rates for blood cancer patients as well as offer a potential new paradigm for treating autoimmune diseases.
"Toward our quest of making transplants even safer for adults and children with leukemia, lymphoma, multiple myeloma, and other blood and marrow disorders, we are exploring the possibility of using T-regs to enhance the rate of blood and marrow recovery and reduce the risks of graft-versus-host disease, a complication that affects more than 60 percent of patients," said Claudio Brunstein, M.D., Ph.D., principal investigator of the study.
On 09/07/07, doctors infused the T-regs in the patient to see if they protected her, while a separate stem cell transplant repaired her damaged blood and immune systems. Doctors are closely monitoring the woman, who is in her 20's and who has leukemia, since receiving the cellular therapy. The federally funded trial comes after more than 3 years of basic research and trials in mice, which showed no side effects.
University researchers hope to prove that T-reg cells can prevent graft-versus-host disease (GVHD) and to learn the appropriate dosage to give patients. GVHD occurs when the immune cells within the donated cells attack the body of the transplant recipient. Further studies likely would be needed, however, before the U.S. Food and Drug Administration would allow the experimental cells to be used in mainstream medicine.
Illustration: U of Minnesota.
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