Clinical trial of adult stem cells takes another step forward
Dr. Gary Gilkeson, Professor of Medicine/Microbiology and Immunology at the Medical University of South Carolina, recently was awarded a planning grant in the amount $255,067 from the National Institute of Allergy and Infectious Diseases (NIAID) to prepare for a multi-center controlled trial of mesenchymal stem cells (MSCs) for the treatment of adults with moderate to severely active lupus.
Previously, Dr. Gilkeson had received a $100,000 grant in 2012 from the Lupus Foundation of American National Peer-Review Research Program to conduct preliminary studies and to remove many of the roadblocks of clinical trials of adult stem cells in lupus. Data gained from that study enabled Dr. Gilkeson and his team to advance to the next step in the process and apply for the planning grant from NIAID. The long-term goal of this line of lupus research is to determine whether MSCs are a safe and effective therapy for lupus.
There have been other studies involving mouse models and uncontrolled trials in human lupus patients that provided evidence suggesting infusions of mesenchymal stem cells derived from healthy adults may be a safe and effective therapy to reduce lupus disease activity, with few side effects.
The current NIAID planning grant will enable Dr. Gilkeson and colleagues to obtain approval from the U.S. Food and Drug Administration (FDA) to conduct controlled studies at six centers in the United States. The trial will involve 50 patients with lupus and an equal number of matched controls who will receive standard care. Dr. Gilkeson anticipates that the trial will get underway sometime in 2016.
In this video, Dr. Gilkeson, who also chairs the Lupus Foundation of America Medical-Scientifiic Advisory Council, discusses the role of adult stem cells in the human immune system and how they can be used to manage lupus.