Exploring a Different Approach to Multiple Sclerosis
Multiple sclerosis, or MS, is a condition in which inflammation and abnormal immune activity damage the brain, spinal cord, and nerves over time. Current treatments can help control relapses and slow progression, but researchers continue to explore new approaches that may also support the body’s natural repair processes.
A 2024 Phase I/II clinical study investigated whether umbilical cord-derived mesenchymal stem cells (UC-MSCs) could be safely used in people with MS and whether receiving two doses might offer different benefits than receiving just one.
How the Study Worked
The study included 35 people with multiple sclerosis.
Researchers divided participants into two groups:
- 20 participants received two UC-MSC treatments, given one month apart.
- 15 participants received one UC-MSC treatment.
Each treatment contained 150 million UC-MSCs. Part of the dose was given intravenously, while the rest was delivered into the fluid surrounding the spinal cord.
Three months after the first treatment, participants in both groups also received conditioned media produced by UC-MSCs. This fluid contains substances naturally released by the cells that researchers believe may play a role in their effects.
Participants were then followed for up to 12 months, with researchers examining disability, physical function, cognitive performance, quality of life, brain imaging, and changes in the immune system.
What Happened After Treatment?
One of the main measurements was the Expanded Disability Status Scale (EDSS), which is commonly used to track disability in people with MS. Both groups showed improvement over the first several months. By six months, disability scores had improved significantly in both groups, with an average decrease of about one point on the EDSS scale.
The group receiving a single UC-MSC dose continued to show a significant improvement at 12 months, while researchers noted several other encouraging findings in the group that received two doses.
More Than One Measure of Progress
MS can affect much more than mobility, so the researchers looked at several different areas.
Participants receiving two UC-MSC doses showed encouraging changes in areas such as:
- General health and energy
- Manual dexterity
- Information-processing speed
- Certain brain-imaging measurements
- Immune-cell activity
Brain scans also showed a trend towards reduced MS lesion volume in the two-dose group after 12 months, although this change did not reach statistical significance.
Researchers also observed differences in cortical thickness, which is the outer layer of the brain involved in many important functions with the findings generally appearing more favorable in the two-dose group.
How Might UC-MSCs Help?
UC-MSCs are being studied in MS partly because of their ability to communicate with the immune system. Rather than simply replacing damaged nerve cells, these cells release biological signals that may help influence inflammation and support the body’s own repair environment.
Researchers found changes in several immune-related cells and genes after treatment. Some inflammation-related signals decreased, particularly in participants receiving two UC-MSC doses.
These findings suggest that UC-MSCs may be doing more than producing changes that can be seen on physical tests, they may also be influencing some of the biological processes involved in MS.
What Did the Safety Results Show?
Safety was an important part of this early-stage trial. Researchers reported no serious treatment-related adverse events.
The most common temporary symptoms included:
- Headache
- Mild fever
- Discomfort around the lower back following treatment
These symptoms resolved before the first month of follow-up. Blood and spinal-fluid testing also did not reveal significant safety concerns compared with baseline measurements.
Is Two Better Than One?
One of the most interesting questions in this study was whether giving UC-MSCs more than once could make a difference. The answer is not completely straightforward.
Both groups experienced improvements, and the one-dose group maintained a significant improvement in disability score at 12 months. However, researchers found a wider range of encouraging changes in the two-dose group, including findings related to brain imaging, cognitive and physical performance, and immune activity. This led the researchers to suggest that multiple doses may deserve further investigation.
An Encouraging Step for Future MS Research
This was a relatively small, open-label study, and the two groups were not perfectly matched in the types of MS they had. For example, the two-dose group included more people with secondary-progressive MS, while the one-dose group included more people with relapsing-remitting MS. That makes larger, carefully controlled studies especially important before firm conclusions can be made.
Still, the results provide an interesting look at how UC-MSC therapy may affect multiple parts of MS at once, from physical function and quality of life to brain imaging and immune activity. Most importantly, both treatment approaches were well tolerated during the study.
As research continues, studies like this may help scientists answer an increasingly important question in regenerative medicine: not simply whether cell therapy can be used safely, but how the dose and timing of treatment may influence the results patients experience.
Source
Jamali F, Aldughmi M, Atiani S, et al. Human Umbilical Cord–Derived Mesenchymal Stem Cells in the Treatment of Multiple Sclerosis Patients: Phase I/II Dose-Finding Clinical Study. Cell Transplantation. 2024;33:09636897241233045. doi: 10.1177/09636897241233045. PMID: 38450623; PMCID: PMC10921855. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC10921855/
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