Stroke Outcomes Improve After Mesenchymal Stem Cell Transplantation

By Will Boggs MD

NEW YORK (Reuters Health) - Surgical transplantation of bone marrow-derived mesenchymal stem cells (SB623) is associated with improved clinical outcomes in patients with stable, chronic stroke, according to results from a phase 1/2a study.

"The most interesting and surprising result was the remarkable improvement in neurologic function that the patients showed following the stem cell implant, considering they were six months to three years since their original stroke, with little hope for further recovery," Dr. Gary K. Steinberg, from Stanford University School of Medicine in California, told Reuters Health by email.

A recent meta-analysis of preclinical studies showed that mesenchymal stem cells could improve neurological function in ischemic stroke and that the intracerebral route provided the greatest improvement.

Dr. Steinberg and colleagues evaluated the safety and clinical outcome of the stereotactic placement of SB623 cells at the margin of stroke in 18 patients with chronic motor deficits six to 60 months after their initial stroke.

Among the 16 patients who had completed at least 12 months of follow-up, mean European Stroke Scale total scores improved by 6.88 points from baseline (p<0.001), with improvement starting at one month and persisting at all other time points.

Average NIH Stroke Scale total scores also improved at all time points starting at one month, with an average 12-month improvement of 2.00 points (p<0.001), according to the June 2 online report in Stroke.

Fugl-Meyer total and motor function scores improved significantly from baseline, but there was no significant change in the modified Rankin Scale score at 12 months.

Thirteen patients showed new signal changes on MR T2 FLAIR imaging, and these changes correlated with improvements in clinical outcomes.

All patients experienced at least one treatment-emergent adverse event in the 12 months after implantation of SB623 cells, most commonly headache related to the surgical procedure itself. Only four events in 18 patients were deemed to be possibly related to the stem cells, and there were no events deemed to be probably or definitely related to cell treatment.

"We are still at an early stage of investigation, but hopefully these transplants will be proven effective in larger, randomized, controlled studies that will lead to routine treatment of chronic stroke patients using similar stem cell transplantation techniques," Dr. Steinberg said.

"We don't want to oversell the impact of this small study, but the fact that our chronic stroke patients as a group showed a significant and clinically meaningful neurologic recovery following the transplant changes our previous notion that these neurologic circuits were irreversibly damaged and couldn't be resurrected," Dr. Steinberg concluded. "This gives us great hope that we will be able to improve neurologic function even in patients who suffered their strokes years ago and remain disabled."

"It is important to note that this study showed that the transplant procedure itself is safe and feasible, with minimal adverse effects, and none related to the cells," he added.

SanBio Inc. funded this research. Three coauthors reported disclosures.

SOURCE: https://bit.ly/286B4de

Stroke 2016.

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