When it comes to treating stroke, time is brain.
The only stroke medication currently available must be given within three hours to achieve maximum benefit. Unfortunately, many patients do not make it to the hospital in time to receive it. A newly developed potential treatment involving the use of stem cells to promote brain recovery may greatly extend this window.
New data from a phase II clinical trial show this treatment can be effective up to 48 hours after the onset of stroke. The research published today in The Lancet Neurology.
“If these results are confirmed, this would really open up the number of patients who would be able to receive treatment for their strokes,” said study co-author Wayne Clark, M.D., a professor of neurology in the OHSU School of Medicine and director of the OHSU Stroke Program.
OHSU was the top-enrolling study site among 33 worldwide.
The global study involved a total of 129 participants, 65 of whom received stem cells grown from bone marrow and given intravenously, and 61 who received a placebo within the first 48 hours of the stroke’s onset. The results showed that the stem cell treatment could be done safely with no negative side effects. In addition, the researchers found participants treated with stem cells showed improvement in several measures of neurologic recovery at one year compared with controls. The stem-cell treated patients also were found to have a lower chance of having a serious infection.
Current treatment options for this type of stroke, known as ischemic, involve the use of intravenous tissue plasminogen activator, or TPA, or removing the clot through a procedure known as thrombectomy, available at comprehensive stroke centers like OHSU. However, due to shorter time windows, “less than 5 percent of patient’s with ischemic stroke are able to receive these therapies,” the authors wrote. “Hence, there is a large unmet need for safe, effective, and widely available treatments for acute stroke beyond six hours from symptom onset.”
Stem cell therapy also can be given in addition to either TPA or thrombectomy as almost half of the participants in the trial received one of these before the stem cells were started.
The study appeared to show the largest benefit with participants treated in the first 36 hours. The next step invovles a phase III clinical trial. Researchers will focus on expanding the number of participants and reducing the time window after stroke to less than 36 hours until start of therapy.
The study was sponsored and supported by Athersys Inc.