Researcher Launches Nation’s First Clinical Trial Using Stem Cells to Treat Alzheimer’s Disease

A new clinical trial at the University of Miami Miller School of Medicine will be the first in the U.S. to focus on using mesenchymal stem cells to treat Alzheimer’s disease.

“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. He is the principal investigator for the phase 1 clinical trial, which is designed to determine the safety of this treatment strategy.

Baumel has collaborated with Joshua Hare, M.D., Louis Lemberg Professor of Medicine and Director of the Miller School’s Interdisciplinary Stem Cell Institute (ISCI), using mesenchymal stem cells (MSCs) developed by Longeveron, a UM life sciences spin-off company. MSCs have the ability to develop into brain cells, as well as many other types of cells throughout the body.

“Stem cells are very potent anti-inflammatories,” said Baumel. “Because the amyloid plaques found in the brains of Alzheimer’s disease patients are associated with inflammation, infusions of stem cells may help to improve or stabilize that condition.”

“We are very excited 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, and we are very excited to have developed information suggesting that these cells should be tested in this patient population.”

Baumel added that stem cells might also help trigger the production of new brain cells in the hippocampus.

“Those new brain cells may then be able to replace damaged cells in Alzheimer’s patients,” he said.

“Alzheimer’s disease is one of the largest threats to our aging population, and we need more innovative treatments to combat this disease,” said Ralph L. Sacco, M.D., M.S., professor and Olemberg Chair of Neurology. “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,” will begin in early 2016 and continue to 2018. The study will also look at changes to participants’ cognitive functions, quality of life and brain volume to gain a preliminary understanding of the potential effectiveness of this strategy.

The clinical trial will be open to individuals with mild Alzheimer’s disease symptoms who are otherwise healthy. For more information about participating in this clinical trial, call 305-243-6633 or email .(JavaScript must be enabled to view this email address).

Funding for the trial was provided by the Ohrstrom Foundation, the Wolfson Foundation, Department of Neurology Advisory Council member Erin Borger and Longeveron.

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