A clinical trial of the Muse cell preparation for cerebral infarction patients conducted at Tohoku University Hospital confirmed its safety and reported results suggesting its effectiveness, including early recovery of upper limb function.
With the arrival of a super-aging society, the number of cerebral infarction patients is steadily increasing.Because the brain has poor regenerative ability, more than half of patients will have aftereffects, and expectations are rising for stem cell therapy that has the potential to regenerate the brain itself.
Muse cells (Multilineage-differentiating Stress Enduring Cells) are naturally pluripotent stem cells discovered by a group at Tohoku University in 2010.Just by administering it intravenously, it accumulates in injured tissue and spontaneously differentiates into cells appropriate for that tissue, repairing the tissue.This time, we investigated the safety and efficacy of a single intravenous infusion of Muse cell preparations into 14 patients with physical dysfunction within 28 to 35 days after the onset of cerebral infarction. A double-blind, placebo-controlled comparative study was conducted.
As a result, regarding the primary endpoint of safety up to 52 weeks after administration of the Muse cell preparation, no significant side effects were observed that would pose a problem in proceeding with the clinical trial.
Regarding efficacy, before administering the Muse cell preparation or a placebo, most patients scored 4 (mRS) on the modified Rankin Scale (a scale for evaluating the severity of diseases that cause abnormalities in neuromotor function: mRS). However, 5 weeks after administration, 12% of the Muse cell preparation group had an mRS of 40 to 0 (no disability at all to a level of independence in daily life). reached.In contrast, only 2% of participants in the placebo group achieved mRS 10-0.After 2 weeks, 52% of the Muse cell group achieved mRS 68.2-0, compared with 2% of the placebo group. In the Muse cell-administered group, significant recovery in motor function was observed, especially in the upper limbs, with statistically significant improvement compared to the placebo-administered group observed from week 37.5 to week 4.
The above results suggest that Muse cells can be a safe and effective treatment for subacute cerebral infarction.In the future, it is hoped that larger-scale research will confirm the effectiveness and lead to practical application.
Paper information:[Journal of Cerebral Blood Flow and Metabolism] Randomized Placebo-Controlled Trial of CL2020, an AllogenicMuse Cell–Based Product, in Subacute Ischemic Stroke
