A study being conducted at the University of Bristol which is looking into whether it is safe to treat people suffering from chronic multiple sclerosis with stems cells from their bone marrow has yielded encouraging preliminary results.
Six patients with chronic multiple sclerosis (MS) were injected with stem cells harvested from their own bone marrow. According to the researchers led by Prof Neil Scolding this treatment increased nerve function by up to 20%. However, the research is still in its infancy and a much larger trial is being planned in the future.
Says Professor Scolding:
“We are encouraged by the results of this early study. We believe that stem cells mobilised from the marrow to the blood are responsible, and that they help improve disease in several ways.”
More information on the research from this NHS Q&A:
What kind of research was this?
This was a phase I clinical trial investigating whether it is safe and feasible to give people with multiple sclerosis (MS) bone marrow stem cell therapy. MS is the most common neurological condition among young adults in the UK, affecting approximately 85,000 people. The condition affects the central nervous system (the brain and spinal cord), which controls the body’s actions and activities, such as movement and balance.
Each nerve fibre in the central nervous system is surrounded by a substance called myelin. Myelin helps the messages from the brain travel quickly and smoothly to the rest of the body. In MS, the myelin becomes damaged, disrupting the transfer of these messages.
Myelin is made by a type of brain cell called an oligodendrocyte. Bone marrow contains stem cells that can develop into brain cells. Research in animal models of MS indicates that bone marrow stem cells encourage the repair of myelin, and help to prevent the loss of oligodendrocytes and damage to nerve cells. Bone marrow stem cell therapy has been used in patients for other conditions.
What did the research involve?
The study recruited six people who had chronic multiple sclerosis for more than five years. Bone marrow was harvested from the patient’s pelvis under general anaesthetic. The bone marrow (containing a mixture of cell types including stem cells) was then filtered and transfused back into the patient over one to two hours.
The patients were followed-up for 12 months after the transfusion. Their disease progression was assessed using the Extended Disability Status Score (EDSS) and the MS Functional Composite, which looks at factors such as the patients’ walking speed and their dexterity.
The patient’s brainwave patterns were also examined using electrophysiological electrodes placed on the surface of the patient’s scalp. This looked at how quickly the brain responded to visual, auditory and tactile stimuli (people with MS may have a longer interval between the stimulus and the brain response, indicating that the nerve signals are being impeded). MRI scans were also taken to count the number of lesions (areas where the nerve cells did not have myelin insulation).
The patients were also assessed for any side effects of the treatment.
What were the basic results?
None of the six patients experienced any severe side effects. However, three patients had moderate side effects, such as a temporary increase in the spasticity of their legs and a temporary inability to pass urine.
One patient had a relapse of MS within two months of the treatment, which was resolved when treated with steroids. The other five patients showed no sign of disease progression, and their EDSS disability score remained unchanged. Improvements were seen in the MS Functional Composite but these changes were not significant.
The recordings of brainwave patterns showed an improvement compared to before the treatment. This improvement was apparent within three months of the treatment (p=0.07) and was maintained at one year after the treatment (p=0.02).
There was a trend for an increased number of lesions at three weeks, but this was not statistically significant, and the trend disappeared by three months after treatment.
How did the researchers interpret the results?
The researchers suggest that the procedure, carried out as a day-case treatment in people with MS, was well-tolerated and not associated with any serious adverse effects. They say that “these results are preliminary evidence of the “possible benefit of bone marrow cellular therapy in patients with MS”. They say these findings warrant further investigation in a randomised placebo-controlled phase II/III clinical trial, with a longer follow-up period.
Conclusion
This very preliminary research has demonstrated that transfusing filtered bone marrow cells into people with MS did not cause serious side effects in this small group of six patients. The patients’ disability remained stable, and there was an improvement in their brain response to stimuli compared to before the treatments.
This study did not compare the stem cell treatment to a placebo group, and it was conducted in a very small group of individuals. As such, it is not possible to say whether these changes are due to the treatment, or if they would have happened anyway. It is also possible they are due to a placebo effect or simply by chance.
Despite being at a preliminary stage, these results are encouraging and need further investigation. The next stage would be to carry out a further safety assessment in a larger patient population, and to compare the treatment to a placebo or an existing treatment to see whether it stabilises or improves MS symptoms over time.
