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According to preliminary findings from a clinical trial, injecting a particular type of stem cell into the brains of patients with progressive multiple sclerosis (MS) is safe, well-tolerated, and has a long-lasting effect that seems to shield the brain from additional harm.

In order to create an enhanced cell therapy treatment for progressive multiple sclerosis, a multinational team conducted a first-in-human, early-stage clinical experiment in which 15 patients with secondary MS had their brains directly injected with neural stem cells.

“We desperately need to develop new treatments for secondary progressive MS, and I am cautiously very excited about our findings, which are a step towards developing a cell therapy for treating MS,” said Professor Stefano Pluchino from the University of Cambridge, who co-led the study with researchers at Milan Bicocca and Hospital Casa Sollievo della Sofferenza in Italy.

Around 2 million people worldwide suffer from multiple sclerosis (MS). Although there are treatments that can lessen the severity and frequency of relapses, two-thirds of MS patients still enter a crippling secondary progressive phase of the disease within 25 to 30 years of diagnosis, during which their disability gradually worsens.

The protective wrapping around nerve fibers, known as myelin, is attacked and damaged by the body’s immune system in multiple sclerosis (MS), disrupting communications that travel through the brain and spinal cord.

The brain tissue of a single miscarried fetal donor provided the stem cells used in the injections.

Over a 12-month period, the team monitored the patients and saw no significant adverse events or treatment-related fatalities. Although there were some negative effects, they were all transient or easily remedied.

At the beginning of the experiment, all of the patients had severe degrees of disability; for example, the majority needed wheelchairs. However, none of the patients had any worsening of their symptoms or rise in disability during the course of the 12-month follow-up period.

Throughout the trial, none of the patients experienced any symptoms that would indicate a relapse, and their cognitive ability did not deteriorate noticeably.

Though it is challenging to verify given the high levels of handicap at the beginning of the experiment, overall, the researchers concluded that this suggests a significant stability of the disease without indications of advancement.

“We recognise that our study has limitations — it was only a small study and there may have been confounding effects from the immunosuppressant drugs, for example — but the fact that our treatment was safe and that its effects lasted over the 12 months of the trial means that we can proceed to the next stage of clinical trials,” Pluchino said.

Additionally, a subgroup of patients was evaluated by the researchers for alterations in brain tissue volume linked to the advancement of the disease. They discovered that the gradual decrease in this brain volume was less the higher the dosage of transplanted stem cells. It is hypothesized that this could be the result of the stem cell transplant reducing inflammation.

 

 

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