In a recent presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024, new data from an interim analysis of an extension study revealed positive outcomes associated with intrathecal injection of autologous bone marrow-derived mesenchymal stem cells (MSCs) in patients with progressive multiple sclerosis (MS).
Dimitrios Karussis, MD, Ph.D., the study investigator and Chairman of the Multiple Sclerosis Center at Hadassah Hospital in Jerusalem, Israel, reported that after a minimum of 1 year of follow-up with 23 participants in the extension analysis, favorable effects were observed in cognitive function, neurological functional tests, quality of life, and two major biomarkers linked to neurodegeneration.
The initial clinical study, published in Brain in 2020, involved 48 randomly assigned participants receiving intrathecal or intravenous injections of MSCs or a sham injection. A second injection was administered at 6 months, with those initially receiving a sham injection and later receiving either intrathecal or intravenous injections of MSCs.
At the end of 1 year, 58.6% of participants receiving two intrathecal injections showed no evidence of disease activity, compared to 40.6% in the intravenous group and 9.7% in the sham group. The intrathecal injections demonstrated greater efficacy, showing benefits in T2 lesion load reduction, lower relapse rates, and sustained cognitive function.
In the extension study, 23 patients received one to three intrathecal injections of MSCs at 3-6 month intervals, with statistically significant improvements in cognitive function, the Symbol Digit Modalities Test, the 25-foot walk test, and quality of life. Reductions in serum neurofilament light chain (sNfL) levels (33.2%) and glial fibrillary acid protein (GFAP) levels (22%) were also noted, supporting the potential neuroprotective effects of MSCs.
While acknowledging the need for longer follow-up and larger studies, Karussis suggested that the consistently positive outcomes hint at possible neuroprotective and neurotrophic effects. However, Jeffrey A. Cohen, MD, Director of the Experimental Therapeutics Program at the Mellen MS Center, Cleveland Clinic, emphasized the uncertainty in results across different studies and the need for further research to establish the reliability of clinical benefits from MSC transplantation in progressive MS patients.
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