The national co-principal investigator of the study, Dileep R. Yavagal, M.D., associate professor of neurology at the Miller School, presented the discovery abstract of the RECOVER-Stroke trial entitled Intra-Arterial Delivery of Autologous ALDHbr Cells in Ischemic Stroke: Final 1-Year Results of the RECOVER-Stroke Trial at the European Stroke Organization Conference, in the UK. The findings provide new hope for future stroke treatments as well as for other brain-related illnesses.
“We are excited by the findings of the new study as it offers promise for stroke victims and for those with other neurological conditions,” says Yavagal, who is also Director of Interventional Neurology, Co-Director of Endovascular Neurology, associate professor of neurological surgery and a member of the Interdisciplinary Stem Cell Institute. “Previous thought was that stem cell use for brain conditions could lead to worsening stroke or even brain cancer. The conclusions of our research prove that stem cells are safe when given through the carotid artery with a small catheter to treat neurological illnesses, and we can continue to explore the efficacy of stem cells for treatments.”
After a full year of stem cell injections, no increased serious adverse effects were detected in any patients. Specifically, no ischemia-related neurologic worsening was seen as a result of the intra-carotid infusion of stem cells. The intra-arterial approach for cell delivery is worth pursuing for cell-based stroke therapy in future larger studies.
“We are extremely proud to be able to impact the direction of stem cell research with studies like RECOVER-stroke,” says Joshua M. Hare, M.D., Director of the Interdisciplinary Stem Cell Institute and Louis Lemberg Professor of Medicine. “We look forward to both witnessing and acting as a key player in the medical innovations that result from these findings.”
The University of Miami was the only east coast institute to participate in the nationwide multi-center RECOVER-Stroke trail that led to the discovery. The study was sponsored by clinical-stage biopharmaceutical company, Aldagen, which has since been acquired by Nuo Therapeutics, Inc. The goal of the trial was to assess the safety and preliminary efficacy of intra-arterial delivery of stem cells. The University of Miami recruited the second highest number of patients in the trial. In total, 48 patients participated in the study: 19 received the placebo and 29 received IA ALDHbr cells, which were manufactured by Aldagen. All patients in the double-blind study received stem cells intra-arterially 13-19 days post-stroke. At 24 hours patients were assessed for clinical worsening and at one year for serious adverse effects and radiological worsening. Efficacy on multiple functional disability scales was evaluated at 90, 180 and 365 days.
“This study opens the door to future clinical trials that will explore new methods of repairing damage to the brain with cell-based therapies,” says Ralph L. Sacco, M.D., M.S., professor and Chairman of Neurology and Chief of Neurology Services at Jackson Memorial Hospital. “Stroke researchers now know that stem cells can be used safely and efficiently without compromising the health of the patient. We have more work to do in this promising area to improve the outcomes of our stroke patients.”
While stem cell research continues to prove to be a viable form of therapy in other areas, doctors hope to have the same success in finding new stem cell therapies for the treatment of neurological illnesses. Yavagal continues to study new strategies to improve the delivery of stem cells via catheter into the carotid artery for treatment of stroke. He has received funding for his research from the NIH CTSI, Florida Biomedical Agency, and the Anderson Family.
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