Major Lupus Stem Cell Study Receives Funding
The Lupus Foundation of America will provide $3.8 million in funding over the next five years to support the first-of-its-kind clinical trial in the United States to evaluate adult mesenchymal stem cells (MSC) as a treatment for lupus. This innovative study is led by Gary Gilkeson, M.D., and Diane Kamen, M.D., of the Medical University of South Carolina (MUSC) and marks a bold step forward in lupus research, which has only had one drug that was specifically developed for lupus and approved by the U.S. Food and Drug Administration (FDA).
The study will determine if MSC stem cell therapy may diminish the often debilitating long-term effects of lupus, reduce the need for medications like steroids, which have harmful side effects, and stop damage to vital organs. Results from initial studies in China show a significant majority of patients whose disease did not respond to current therapies benefited from this type of stem cell therapy, and few patients experienced adverse reactions. In order to continue, this therapy must now be tested through randomized placebo controlled clinical trials to show that it is both safe for people with lupus and more effective than the standard for treatment alone. For this study,one-third of the participants will receive a placebo infusion and the other two-thirds will receive MSC stem cells taken from the umbilical cord of an unrelated donor.
The phase II trial is now moving forward and expected to open enrollment in early 2018 and will recruit a total of 81 individuals with lupus to participate in the study. The trial will also expand to six additional academic centers in Atlanta, Chapel Hill, Chicago, Los Angeles, Rochester, New York City and San Diego.
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