UHealth Launches Clinical Trial to Treat Alzheimer’s
Neurologists at UHealth – the University of Miami Health System are starting a clinical trial to treat Alzheimer’s disease — what will be the first in the U.S. to use mesenchymal stem cells. The study, which is designed to determine the safety of this treatment strategy, will be open to patients at UHealth with mild Alzheimer’s disease symptoms who are otherwise healthy.
“We believe infusions of these types of stem cells have the potential to be beneficial to individuals with Alzheimer’s disease,” said Bernard S. Baumel, M.D., assistant professor of neurology at the University of Miami Miller School of Medicine, and principal investigator for the phase 1 clinical trial.
There is no cure for Alzheimer’s disease, creating a strong need for therapies that can effectively maintain quality of life for patients and their families. In clinical trials designed and led at UM’s Interdisciplinary Stem Cell Institute (ISCI), mesenchymal stem cells (MSCs) have shown the ability to develop into many different types of cells. In addition, MSCs are thought to promote neurogenesis, which allows the brain to produce new cells in the hippocampus. This is the area where new memories form and where Alzheimer’s disease begins. The new brain cells may then be able to replace damaged cells in Alzheimer’s patients.
“Stem cells are very potent anti-inflammatories,” said Baumel, a neurologist at UHealth. “Because the amyloid plaques found in the brains of Alzheimer’s disease patients are associated with inflammation, we hope to determine whether infusions of stem cells can help to improve or stabilize that condition.”
“Alzheimer’s disease is one of the largest threats to our aging population, and we need more innovative treatments to combat this disease,” said renowned UHealth neurologist Ralph L. Sacco, M.D., M.S., professor and Chair of Neurology and the Olemberg Family Chair of Neurologic Disorders.
The study will also look at changes to participants’ memory, cognitive functions, quality of life and brain volume to gain a preliminary understanding of the potential effectiveness of this strategy.
Baumel is collaborating with Joshua M. Hare, M.D., Director of ISCI and Louis Lemberg Professor of Medicine, using mesenchymal stem cells developed by Longeveron, a UM life sciences spin-off company.
“We are thrilled to collaborate with Dr. Baumel and his team on this revolutionary first-in-human concept,” said Hare. “The unmet need for Alzheimer’s disease is extraordinary. After eight years of NIH-funded clinical research using MCS, we are very excited to have developed information suggesting that these cells should be tested in this patient population.”
Sacco adds that, “Multidisciplinary collaborative work between our Department of Neurology and ISCI is a great model of how we can make strides toward more effective treatments for neurodegenerative diseases.”
Enrollment in the clinical trial, “Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients with Alzheimer’s Disease,” is now beginning and will continue to 2018.
Funding for the trial was provided by the G.L. Ohrstrom Jr. Foundation, the Wolfson Foundation, and Department of Neurology Advisory Council member Erin Borger.