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The first two stroke patients have been enrolled in a phase 2 clinical trial of a revolutionary new treatment for ischemic stroke being conducted at the University of Miami/Jackson Memorial Hospital. The trial, using a patient’s own bone marrow stem cells, is the first intra-arterial stroke stem cell trial in the U.S., and the two UM/Jackson patients are the first in Florida to participate.

Led by Dileep Yavagal, M.D., assistant professor of neurology and neurological surgery, the trial is examining the efficacy of ALD-401, derived from bone marrow, to repair and regenerate tissue following an ischemic event.

James Anderson, a physical education teacher from Maine, is hopeful that participating in the double-blind study will help him recover more quickly. “Stroke is not an easy problem. I liked something that was progressive and I could be involved in.”

Four days before Christmas, Anderson and his wife Barbara had just arrived in Naples to visit his mother-in-law when he suddenly grew very pale. Having run three miles the day before, they had no warning that he was having a major stroke. Anderson was given tissue plasminogen activator (tPA) at a West Coast hospital, but was soon airlifted to Jackson Memorial Hospital, a comprehensive stroke center, because of the severity of the stroke. That’s when Yavagal, who is also Director of Interventional Neurology at UHealth, visited the 58-year-old to explain the study.

Once either tPA is administered to break up a blocked artery or a clot-removal procedure is performed, there are no approved therapies for persisting neurological disabilities seen in a significant number of stroke patients despite treatment and rehabilitation. Yavagal believes ALD-401, which is derived from ALDHbr cells isolated from bone marrow and is injected within weeks of a primary ischemic stroke, has the potential to be one. Manufactured by Aldagen, a wholly-owned subsidiary of Cytomedix, Inc., ALD-401 contains all cell types thought to repair and regenerate tissue following an ischemic event and offers multiple mechanisms of action.

The middle school teacher’s wife, Barbara, said they discussed it with the family and she and James “felt it was right and a way to help others as well…. We really want to be in on the beginning of this so others can benefit.”

Yavagal performed Anderson’s study procedure on January 11, making him the second person to be enrolled in the University of Miami/Jackson Memorial Hospital arm of the nationwide trial known as RECOVER-stroke. Approximately 100 patients in the U.S. will be enrolled and randomized within the trial. About 60 of those patients will receive an intra-carotid infusion of stem cells, while the others will receive a placebo. None will know what they received until the trial’s end. Twenty patients are expected to be enrolled in the Miller School trial.

Yavagal is a leader in research of the intra-arterial delivery of stem cells for stroke and has been funded for this research over the last four years. He works in close collaboration with Joshua M. Hare, M.D., Director of the Interdisciplinary Stem Cell Institute, to translate the promise of stem cells for stroke patients. He is on the national steering committee of the RECOVER-Stroke trial.

With intra-arterial delivery, the cells are delivered directly to the brain via the carotid artery, avoiding their becoming trapped in the lungs and liver, which occurs when stem cells have been administered intravenously. Yavagal, who is also Co-Director of Endovascular Neurosurgery and a faculty member of the Interdisciplinary Stem Cell Institute, says this trial is “hugely significant” because of its delivery method. Despite the availability of tPA and clot-removal procedures, fewer than 40 percent of stroke patients regain their independence.

Anderson was left paralyzed along his left side but can speak. The first person to be enrolled, a 60-year-old Hialeah man, is using a walker but has lost his speech for now. The study is blinded, so neither patient knows whether they received the stem cells or not. They will receive MRI and CT scans regularly to monitor their progress.

An avid fisherman, Anderson instills exercise as a way of life to his students. For now, he’s receiving occupational and recreational therapy along with speech and physical therapy. He is hopeful that his rehabilitation and the stem cell treatment will decrease his recovery time, allowing him to return to his “regular life” sooner. Anderson says he finds encouragement from Yavagal. “I’m inspired by him whenever I see him and talk to him. He’s progressive and cares about people.”

 

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