Adult stem cells are safe as well as feasible for treatment of stroke in patients, according to the published results of a ground-breaking Phase I trial from the University of Texas Health Science Center at Houston.
Looking at ten patients in this first study, the researchers found no study-related severe adverse events, and while the study was not designed to determine effectiveness, the team found that most of the patients did better compared with matched untreated patients.
Dr. Sean Savitz, first author, said:
“In order to bring stem cells forward as a potential new treatment for stroke patients, we have to establish safety first and this study provides the first evidence in addressing that goal. Now we are conducting two other stroke cell therapy studies examining safety and efficacy, one of which can be administered up to 19 days after someone has suffered a stroke.”
Results of the study were published in the journal Annals of Neurology.
Editor’s Note: The following, from the researchers, provides more information:
Of the 10 patients enrolled in the study, there were no study-related severe adverse events. Although the study was not intended to address efficacy, the investigators compared the study group with historical control patients, who admitted to the stroke service at Memorial Hermann-TMC before the trial began. In that comparison, the study team found a number of patients who did better compared with controls. However, Savitz said that type of analysis has limitations.
Stroke occurs when blood flow to the brain is interrupted by a blockage or a rupture in an artery, depriving brain tissue of oxygen. It is the third-leading cause of death behind heart disease and cancer and a leading cause of disability. According to the American Stroke Association, nearly 800,000 Americans suffer a stroke each year – one every 40 seconds. The only current treatment for ischemic stroke, the most prevalent kind, is the clot-buster tPA. But only one-third of patients respond well to tPA, so researchers continue to look at other therapies.
Savitz’ other stem cell studies for stroke are using a regenerative therapy developed by Aldagen that uses a patient’s own bone marrow stem cells injected into the carotid artery; and an umbilical cord-derived cell therapy that can be used “off-the-shelf,” which he hopes to bring to community hospitals so that a larger number of stroke patients in Houston have access to ground-breaking research testing new potential therapies.
The Stroke Team at UTHealth and Memorial Hermann-TMC was part of the original pioneer group of investigators who studied tPA. It is now researching Doppler ultrasound, endovascular treatment, neuroprotection (hypothermia) and new clot-busting medications for ischemic stroke. Clinical trials for intracerebral hemorrhage (bleeding stroke) include a commonly used diabetes drug shown in preclinical trials to speed the removal of blood from the brain, the first and only study of its kind in Houston.
UTHealth’s Department of Neurology is part of the National Institutes of Health’s Specialized Programs of Translational Research in Acute Stroke (SPOTRIAS) Network. The network centers perform early phase clinical projects, share data and promote new approaches to therapy for acute stroke. The network currently includes eight stroke research centers across the country. UTHealth is the only one in the Southern and Southwestern United States.
Memorial Hermann-TMC, a primary teaching hospital of UTHealth, was the first Primary Stroke Care Center in Houston and is the only one to offer stem cell research for stroke. Researchers are affiliated with the Mischer Neuroscience Institute at Memorial Hermann.