First Stem Cell Stroke Trial Begins

Bone marrow stem cells may benefit stroke patients 19 days later

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Time is of essence when a stroke happens. Most traditional stroke treatments are given shortly after onset. A new clinical trial is testing the effectiveness of a stem cell therapy that could be given 19 days later.

The innovative therapy, which uses a patient's own bone marrow stem cells, is suspected to aid in recovery following an ischemic stroke.

"Ask your physician about stroke treatments."

The phase II regenerative therapy study was approved by the U.S. Federal Drug Administration, and marks the country's first double-blind stem cell clinical trial for stroke patients.

Biopharmaceutical company Aldagen, which is also funding the research, provided the proprietary technology to isolate cells that excrete high levels of an enzyme that serve as a marker of stem cells. Cells are intravenously inserted into the carotid artery. The therapy, called ALD-401, has previously been shown to aid recovery following ischemic stroke in mice.

Dr. Sean Savitz, senior investigator for the multi-center study and associate professor of neurology at the UT Health Medical School, said researchers are particularly curious as to whether they can extend the time frame for administering stem cells. If the window for treatment is longer, it may mean an increased number of stroke patients could be helped.

Dr. Savitz already has enrolled the first Texas patient in the study, and is aiding in enrolling participants at other medical facilities. The clinical trial will include 100 patients with unilateral (one-sided) cortical ischemic stroke.

The most successful use of stem cells has been bone marrow transplants to treat leukemia patients. Pre-clinical research has indicated stem cells may promote brain repair following an ischemic stroke, Stroke is the fourth among leading causes of death in the United States.

Savitz and his research team are studying other stem cell therapies for acute stroke, and these must be administered within a few days of the stroke. One of those, a safety and efficacy trial using a patient’s own bone marrow stem cells administered intravenously, is funded by the National Institutes of Health. UTHealth researchers in the Department of Pediatric Surgery also are studying the use of stem cells for pediatric traumatic brain injury.

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Review Date: 
July 19, 2011
Last Updated:
July 21, 2011