Small Phase I Safety Trial of Bone Marrow Stem Cells in MS Completed
Posted May 20 2010 12:00am
May 18, 2010
British researchers report results of a Phase I safety/feasibility clinical trial involving six people with long-standing multiple sclerosis, testing intravenous injections of the patients’ own adult bone marrow cells containing a mix of stem cells. After one year, the investigators found the treatment safe, but because it was a small, open-label trial with no controls, they report that firm conclusions cannot be drawn about its effectiveness. The study, by Neil Scolding, MD (University of Bristol, United Kingdom) and colleagues, is published online on May 5, 2010 in Clinical Pharmacology & Therapeutics.
Background: MS involves immune attacks against the brain, spinal cord and other tissues that make up the central nervous system. For years, researchers have been investigating bone marrow transplantation as a way to reconstitute the immune system in people with aggressive MS whose immune cells have been purposely destroyed, in hopes of stopping the MS immune attacks. This approach is still being investigated as an experimental treatment of MS. Recent studies, largely involving animal models, have suggested that adult stem cells contained in the bone marrow might have the capacity to inhibit destructive immune activity and possibly stimulate tissue repair.
This Study: Six people who had had MS for a duration ranging from 9 to 20 years, and who had moderate to significant disability (scores on the EDSS disease activity scale ranging from 4.5 to 6.5), participated in the study over one year. Each participants’ own bone marrow cells were removed, then filtered and then infused into the vein. None required an overnight hospital stay for the procedure. Rather than separate out a specific type of bone marrow stem cell (such as mesenchymal cells that have received attention as possible repair cells), the research team determined there was sufficient evidence to suggest possible benefit of infusing a mix of whole bone marrow cells.
According to patient reports, they found the procedure tolerable, and no severe adverse events were reported. After the infusion, one participant had postoperative urinary retention, and two had a transient increase in lower limb spasticity. One participant had an MS relapse two months after the infusion.