Cerevast Therapeutics' Clotbust-ER device was shown to be safe according to results published in the journal Stroke.
October 28, 2013 — Researchers at The University of Texas Health Science Center at Houston (UTHealth) led a study that showed that a hands-free ultrasound device, combined with a clot-busting drug, was safe for ischemic stroke patients.
The results of the phase II pilot study were reported today in the American Heart Association (AHA) journal Stroke. Lead author was Andrew Barreto, M.D., assistant professor of neurology, Stroke Program, UTHealth Medical School and attending physician, Mischer Neuroscience Institute. The principal investigator was James Grotta, M.D., professor and chair, Department of Neurology, UTHealth Medical School, distinguished chair, Roy M. & Phyllis Gough Huffington Center and co-director, Mischer Neuroscience Institute at Memorial Hermann-Texas Medical Center.
The device, which uses UTHealth technology licensed to Cerevast Therapeutics Inc., is placed on the stroke patient’s head and delivers ultrasound to enhance the effectiveness of the clot-busting drug tissue plasminogen activator (tPA). Unlike the traditional handheld ultrasound probe that’s aimed at a blood clot, the hands-free device used 18 separate probes and showers the deep areas of the brain where large blood clots cause severe strokes.
“Our goal is to open up more arteries in the brain and help stroke patients recover,” said Barreto. “This technology would have a significant impact on patients, families and society if we could improve outcomes by another 10 percent or more by adding ultrasound to patients who’ve already received tPA.”
In the first study of its kind, 20 moderately severe ischemic stroke patients (12 men and eight women, average age: 63 years) received intravenous tPA up to four-and-a-half hours after symptoms occurred and two hours exposure to 2-MHz pulsed wave transcranial ultrasound.
Researchers reported that 13 (or 65 percent) patients either returned home or to rehabilitation 90 days after the combination treatment. After three months, five of the 20 patients had no disability from the stroke and one had slight disability.
Cerevast Therapeutics has recently launched an 830-patient international, randomized efficacy study of the ultrasound approach combined with the clot buster in ischemic stroke. Barreto is the North American principal investigator for that Phase III study “Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke (Clotbust-ER).” Locally, patients will be recruited from Memorial Hermann-Texas Medical Center, Memorial Hermann Southwest Hospital and Baptist Beaumont Hospital.
The study was conducted at UTHealth and the University of Alabama-Birmingham with funding from the National Institutes of Health (NIH) including the National Institute of Neurological Disorders and Stroke, an NIH training grant and the National Center of Research Resources.
For more information: www.uthouston.edu, www.cerevast.com