Lupus research company the Lupus Foundation of America said on Tuesday that it plans to co-fund a major phase II study to evaluate mesenchymal stem cells (MSC) in the treatment of moderate to severe lupus under a new public-private partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The company said lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body. It is difficult to diagnose, hard to live with, a challenge to treat as well as debilitating and destructive and fatal.
Under the terms of the five year agreement, NIAID will support the lupus study and will fund a data coordination centre, site and safety monitoring and mechanistic studies for the duration of the study.
In the first year of the study, NIAID has committed USD720,000 in funding, which is an addition to the prior USD3.8m in funding over the five years.
The US-based mesenchymal clinical study is expected to open for enrolment in summer 2018 to determine if MSC stem cell therapy may diminish the often debilitating long-term effects of lupus as well as reduce the need for medications like steroids, which have harmful side effects and stop damage to vital organs.
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