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U of M begins nation's first clinical trial using T-reg cells from cord blood in leukemia treatment
September 06, 2007Therapy may lead to a future treatment for diabetes and other autoimmune diseases
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., principal investigator of the study.
T-regs are a type of lymphocyte, or white blood cell that normally regulates the body's immune responses. In the case of transplant, donor T-regs may suppress the recipient's immune system so that the healthy donor's blood-forming stem cells and immune cells can grow, helping ward off life-threatening graft-versus-host-disease (GVHD). GVHD occurs when the immune cells within the donated cells attack the body of the transplant recipient. GVHD causes one-third of deaths after transplant.
Researchers have proven in animal models that infusing T-regs after transplant increases the chance of blood and marrow recovery and decreases the risk of GVHD.
"Once we identified that T-regs were highly effective in mouse models, we then spent three years finding ways to make this therapy valuable for transplant patients and potentially useful for patients with autoimmune diseases," said Bruce Blazar, M.D., director of the Center for Translational Medicine at the University.
The T-regs in this study are isolated from umbilical cord blood (blood collected from the placenta or afterbirth after the birth of a child) because they occur in higher frequency than what is typically found in most adults and are easier to expand in culture prior to treatment. This is the first human clinical trial in the world that uses T-regs derived from umbilical cord blood.
This trial is designed to find the highest possible safe dose of T-regs in immune suppressed patients undergoing a double umbilical cord blood transplant for leukemia, other blood cancer, or bone marrow failure. From data in animal models, University researchers believe there will be no acute side effects with the T-regs.
If the data in humans mimics animal models, T-regs will be a powerful therapy to prevent GVHD and enhance engraftment in transplant patients. Once safety and efficacy data are known, researchers hope to test T-regs for treatment of various autoimmune diseases, such as type I diabetes and multiple sclerosis. University researchers hypothesize that if T-regs are transplanted early in the life of the disease, the cells may help prevent disease progression.
"This is an exciting time. In the near future, I anticipate being able to combine immune cell populations, like T-regs, that stop immune reactions responsible for autoimmune diseases like diabetes, and immune responses to stem cell infusion given to repair already damaged tissues. This brings great hope not only for adults and children with cancer but many other diseases as well. At the close of this clinical trial, we hope to go right to our first clinical trial with T-regulatory cells in the treatment of newly diagnosed diabetes," said John E. Wagner, M.D., director of the pediatric hematology-oncology and blood and marrow transplantation program at the University of Minnesota.
University of Minnesota
"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., principal investigator of the study.
T-regs are a type of lymphocyte, or white blood cell that normally regulates the body's immune responses. In the case of transplant, donor T-regs may suppress the recipient's immune system so that the healthy donor's blood-forming stem cells and immune cells can grow, helping ward off life-threatening graft-versus-host-disease (GVHD). GVHD occurs when the immune cells within the donated cells attack the body of the transplant recipient. GVHD causes one-third of deaths after transplant.
Researchers have proven in animal models that infusing T-regs after transplant increases the chance of blood and marrow recovery and decreases the risk of GVHD.
"Once we identified that T-regs were highly effective in mouse models, we then spent three years finding ways to make this therapy valuable for transplant patients and potentially useful for patients with autoimmune diseases," said Bruce Blazar, M.D., director of the Center for Translational Medicine at the University.
The T-regs in this study are isolated from umbilical cord blood (blood collected from the placenta or afterbirth after the birth of a child) because they occur in higher frequency than what is typically found in most adults and are easier to expand in culture prior to treatment. This is the first human clinical trial in the world that uses T-regs derived from umbilical cord blood.
This trial is designed to find the highest possible safe dose of T-regs in immune suppressed patients undergoing a double umbilical cord blood transplant for leukemia, other blood cancer, or bone marrow failure. From data in animal models, University researchers believe there will be no acute side effects with the T-regs.
If the data in humans mimics animal models, T-regs will be a powerful therapy to prevent GVHD and enhance engraftment in transplant patients. Once safety and efficacy data are known, researchers hope to test T-regs for treatment of various autoimmune diseases, such as type I diabetes and multiple sclerosis. University researchers hypothesize that if T-regs are transplanted early in the life of the disease, the cells may help prevent disease progression.
"This is an exciting time. In the near future, I anticipate being able to combine immune cell populations, like T-regs, that stop immune reactions responsible for autoimmune diseases like diabetes, and immune responses to stem cell infusion given to repair already damaged tissues. This brings great hope not only for adults and children with cancer but many other diseases as well. At the close of this clinical trial, we hope to go right to our first clinical trial with T-regulatory cells in the treatment of newly diagnosed diabetes," said John E. Wagner, M.D., director of the pediatric hematology-oncology and blood and marrow transplantation program at the University of Minnesota.
University of Minnesota
Autoimmune Disease Current Events and Autoimmune Disease News RSSFactors from common human bacteria may trigger multiple sclerosis
Current research suggests that a common oral bacterium may exacerbate autoimmune disease. The related report by Nichols et al, "Unique Lipids from a Common Human Bacterium Represent a New Class of TLR2 Ligands Capable of Enhancing Autoimmunity," appears in the December 2009 issue of The American Journal of Pathology.
Largest gene study of childhood IBD identifies 5 new genes
In the largest, most comprehensive genetic analysis of childhood-onset inflammatory bowel disease (IBD), an international research team has identified five new gene regions, including one involved in a biological pathway that helps drive the painful inflammation of the digestive tract that characterizes the disease.
Researchers find new way to attack inflammation in Graves' eye disease
A small group of patients with severe Graves' eye disease experienced rapid improvement of their symptoms - and improved vision - following treatment with the drug rituximab.
Kidney transplants generally safe for lupus patients
Individuals with a history of lupus who receive a kidney transplant rarely develop the serious inflammatory condition lupus nephritis in their new organ, according to a paper being presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, CA.
Geneticists Hunt for Scleroderma Triggers
At its most benign, the autoimmune disease scleroderma can discolor parts of the skin of its sufferers. At its most pernicious, it can thicken and harden their skin, their blood vessels, and their internal organs before, in many cases, killing them.
Pain thresholds linked to inflammation and sleep problems in arthritis patients
Despite recent advances in anti-inflammatory therapy, many rheumatoid arthritis (RA) patients continue to suffer from pain.
Stanford study identifies cellular mechanism that causes lupuslike symptoms in mice
Macrophages, the scavenger cells of the body's immune system, are responsible for disposing of dying cells. Stanford University School of Medicine researchers have identified one pathway in this important process in mice that, if disrupted, causes a lupuslike autoimmune disease.
Strategy for mismatched stem cell transplants triggers protection against graft-vs.-host disease
A new technique being tested in stem-cell transplants from imperfectly matched donors has revealed a striking, unforeseen response that can suppress graft-versus-host disease, a common and dangerous complication of mismatched transplants, report scientists from Dana-Farber Cancer Institute.
National report shines light on lupus 50-year treatment drought
Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years - since the Eisenhower Administration.
Promising new target emerges for autoimmune diseases
University of Michigan scientists say they have uncovered a fundamentally new mechanism that holds in check aggressive immune cells that can attack the body's own cells.
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