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 usingMCS, 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.

For more information, call Jonathan Landman at 305-243-6633 or email MemoryProgram@med.miami.edu.

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.

 

Barry Baumel, MD

Barry Baumel, MD

New Study Helps Hispanic Seniors in Miami Fight Depression with Exercise

University of Miami Miller School of Medicine psychologist Daniel Jimenez, Ph.D., assistant professor of psychiatry and behavioral sciences, has just kicked off a study that uses exercise and social engagement as a way to stem depression and anxiety among local Hispanic seniors.

Using a small army of local health promoters or promotoras de salud, Jimenez will enroll 60 Hispanic seniors over age 60, who will take part in group exercise at local parks in Miami-Dade County. His hometown of Hialeah will be one of his first stops for recruitment.

As part of the initiative, groups of six participants will meet three times per week for 16 weeks and perform 10 minutes of stretching and 30 minutes of moderately intense exercise. At the end of each session, the seniors will spend five minutes planning a future activity with a friend or family member, such as going to the movies or another enjoyable outing.

“The idea is for them to keep the body active and keep their minds entertained,” said Jimenez, a Cuban-American who has studied mood disorders among Hispanics for the past seven years. The study, he said, is a novel way of addressing mental health, as it focuses on prevention instead of treatment.

The four-year study is funded by a $670,000 National Institutes of Health grant. It’s Jimenez’s first major undertaking since joining the Miller School in June. Miami, he said, is fertile ground for studying mental health trends among Hispanic communities. But his study is also aimed at intervention and long-term mental health stability.

“By the first two sessions, we hope to see a decrease in symptom severity. By the completion of the study, we hope to see a continued trend,” said Jimenez.

Previous research, he says, has shown that Hispanic seniors in the U.S. have higher rates of depression than their white, non-Hispanic counterparts. Often times, Jimenez says, they feel socially isolated due to feelings of detachment from their homeland.

“Feelings of isolation, especially due to immigration, is a common narrative among this group,” he said, adding that the claim has some validity. However, “often times, people who deal with depression are genetically predisposed to it,” he said. “It just takes a change in their environment, such as immigration, to trigger it. It then becomes an unpleasant stressor.”

Family and cultural connectivity are prominent traits in Hispanic culture, and it’s something that Jimenez knows first-hand. “To be removed from that can be very devastating, especially if you base your whole being on collectivistic culture.”

And while Hispanic seniors share similar anxiety levels with non-Hispanic whites in the U.S., Jimenez explains, they are less likely to seek mental health treatment, which exacerbates the problem.

Elderly Hispanics also have vastly different perceptions of their mental health and what causes the disorder. “You often hear ‘If we hadn’t left Cuba, my spouse wouldn’t have gotten Alzheimer’s.’” Denial and stigma, he says, are also barriers to treatment. Obesity, diabetes and cardiovascular ailments are additional risk factors for depression that are also prevalent among Hispanic seniors.

The study targets seniors who have not yet crossed the threshold of clinical depression or anxiety but show some related symptoms and are identified as being at risk.

Upon recruitment, participants will take a brief questionnaire that assesses their level of community involvement, social support, physical activity, ability to do activities and self-confidence. They will be reassessed with the same questionnaire after six months and a year later.

“The goal is to intervene before the water really gets over their heads and they’re really depressed and not seeking treatment,” said Jimenez.

For more information on the study, contact Dr. Daniel Jimenez at 305-355-9063 or dej18@med.miami.edu .

 

Dietary supplement ‘like a touch of magic’ for Alzheimer’s patients

Miller School study finds dramatic improvements in cognitive functioning

When Rina Torres was diagnosed with Alzheimer’s in her 70s, she gradually lost her ability to communicate or recognize family members. Then, she joined a University of Miami Miller School of Medicine study to test if a dietary supplement, aloe polymannose multinutrient complex (APMC), might improve her mental condition.

“When my grandmother started the treatment, I was very skeptical,” said her grandson, Lisandro Sierra, a doctor in eastern Cuba who enrolled her in the study. “But then I saw her move from darkness to the light. She became more aware of her surroundings, asked for water when she was thirsty, and went to the bathroom by herself. It was like a touch of magic.” Torres’ dramatic improvement lasted until she passed away in 2012 at the age of 84.

Torres was far from the only Alzheimer’s patient to benefit from APMC, made with aloe vera powder containing a minimum of 15% poly acetyl mannose (BiAloe®), according to John E. Lewis, Ph.D., associate professor of psychiatry and behavioral sciences, who led the team of Miller School and Miami Jewish Health Systems researchers.

“A female participant in her 90s was confined to a wheelchair and could not speak,” said Lewis. “Within six months of taking the dietary supplement, she was walking and talking again, and called one of our clinical coordinators by name, much to his surprise.”

“An architect who had Alzheimer’s for eight years, was barely able to speak, and required total care, took the APMC supplement and within a few months remembered his son’s name and carried on a conversation with his wife. She called me in tears to say that it felt like she got her husband back,” Lewis said.

The study of 34 adults with moderate to severe Alzheimer’s disease showed significant improvements in cognitive and immune functioning and stem cell proliferation after consuming 4 teaspoons of APMC per day for a twelve-month period. The study, “The Effect of an Aloe Polymannose Multinutrient Complex on Cognitive and Immune Functioning in Alzheimer’s Disease,” was published last year in The Journal of Alzheimer’s Disease. Miller School co-authors were David A. Loewenstein, PhD., Dahlia Abreu, B.S., Janet Konefal, Ph.D., and Judi M. Woolger, M.D.

Miller School Study Finds Effective Approach for Delivering Stem Cells to Repair Stroke Damage

A new Miller School research study has identified a safe and effective route for delivering stem cells to the brain, where they can potentially repair stroke-damaged tissue.

“Our team found that delivering a low dose of mesenchymal stem cells (MSCs) through the carotid artery at 24 hours after stroke resulted in effective therapy for ischemic stroke in an animal model,” said lead author Dileep Yavagal, M.D., associate professor of clinical neurology and neurological surgery, Director of Interventional Neurology, and Co-Director of Endovascular Neurosurgery. It is the first study to identify a safe dose for intra-arterial delivery of MSCs in a rat stroke model and show the dose to be effective.

“There continues to be a critical need for novel therapies for stroke,” Yavagal added. “Now that we have a scientific foundation in place, we can begin to design clinical trials to translate these laboratory results into treatment strategies.” MSCs in this study were harvested from bone marrow of healthy animals.

The Miller School study, “Efficacy and Dose-Dependent Safety of Intra-Arterial Delivery of Mesenchymal Stem Cells in a Rodent Stroke Model,” was published recently in PLOS ONE, an international research journal.

Stroke is one of the nation’s leading causes of death and long-term disability, with an estimated annual cost of $73.3 billion in 2010. Medical researchers have known for more than a decade that MSCs – derived from bone marrow, adipose (fatty) tissue or other sources – can help repair stroke-damaged brain tissue.

Miller School coauthors were Ami P. Raval, Ph.D., research assistant professor of neurology; Chuanhui Dong, Ph.D., research assistant professor of neurology; Weizhao Zhao, Ph.D., associate professor of neurology; Tatjana Rundek, M.D., Ph.D., professor of neurology; Ralph L. Sacco, M.D., M.S., professor and Olemberg Chair of Neurology; and Miguel Perez-Pinzon, Ph.D., professor of neurology and Director of the Cerebral Vascular Disease Research Center.

Yavagal led the first intra-arterial stem cell trial in the U.S., RECOVER-Stroke. An active member of the Miller School’s Interdisciplinary Stem Cell Institute research team, Yavagal is a peer reviewer for several journals including Stroke, Neurology, Journal for Neurointerventional Surgery and the Journal of Neuroimaging, and has given presentations both nationally and internationally on topics related to neuroscience and neurointervention.