The Lupus Foundation of America recently announced it 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 Mesenchymal stem cells (MSC) as a treatment for lupus.
The 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 treatment alone. For this trial, one-third of the participants will receive a placebo infusion and two-thirds of the participants will receive stem cells from the umbilical cord of an unrelated donor.
The phase II trial is now moving forward and expected to open enrolment in early 2018 and will recruit a total of 81 individuals with lupus to participate in the study.
The trial will also extend to six additional academic centers in Atlanta, Chapel Hill, Chicago, Los Angeles, Rochester, New York City and San Diego.
Lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body. It is difficult to diagnose, hard to live with and a challenge to treat. Lupus is a cruel mystery because it is hidden from view and undefined, has a range of symptoms, strikes without warning, and has no known cause and no known cure. Its health effects can range from a skin rash to a heart attack. Lupus is debilitating and destructive and can be fatal, yet research on lupus remains underfunded relative to diseases of similar scope and devastation.
The Lupus Foundation of America is the only national force devoted to solving the mystery of lupus, one of the world’s cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact. ‘Through a comprehensive program of research, education, and advocacy, we lead the fight to improve the quality of life for all people affected by lupus.’ Learn more about the Lupus Foundation of America at lupus.org. For the latest news and updates, follow us on Twitter and Facebook.