A series of stem cell treatments over time might be more effective than a single injection for a chronic and debilitating condition like Alzheimer’s disease.
That’s the premise for the first clinical trial to evaluate multiple stem cell injections in people living with mild Alzheimer’s disease. The unique study, led by Barry Baumel, M.D., assistant professor of neurology and interim chief of the Cognitive Disorders Division at the Miller School of Medicine, will soon start enrolling participants.
“Alzheimer’s disease is a chronic, progressive deterioration – so over time you expect people to get worse, and indeed they do,” said Dr. Baumel, who is also director of memory disorders clinical trials. “If this treatment is effective, it will probably need to be given as repeated doses, just like for any other chronic disease.”
Dr. Baumel’s team was the first in the U.S. to research stem cell treatment for Alzheimer’s disease.
Unlike previous researchers who evaluated patients after a single injection of stem cells, the new study will inject 10 people with stem cells every 13 weeks for one year.
“Because it’s the first such study in the world, we’re testing safety as well as the effectiveness,” said Dr. Baumel. “So far, there have been no safety issues, and we need to see if there is any efficacy.”
Half the participants will receive 100 million stem cells per injection, while the remaining five patients will get 200 million cells per injection. “Those both sound like big numbers, but in the world of cells, they’re not,” Dr. Baumel said.
Potential candidates for the study include people who are mildly impaired with Alzheimer’s disease, are otherwise healthy and can commit to a year of evaluation and treatment. Participants will complete memory tests at regular intervals and be monitored on a continuous basis.
“We’re not just interested if you remember more words on a list,” he said. “We’re interested to see if the quality of life and level of function improve – because that really determines how beneficial a therapy is.”
Caregivers of participants will also be asked to share their observations about the patient. Dr. Baumel plans to inquire about the quality of life of the caregivers as well. “If you have Alzheimer’s disease, often it’s the people around you who suffer the most.”
Possible ways that stem cells could help people with Alzheimer’s disease include an anti-inflammatory effect and neurogenesis. “Stem cells are very potent anti-inflammatories, and around the areas of degeneration in the brain there is tremendous inflammatory response. And we believe that stem cells promote your body to make your own stem cells through a process called neurogenesis.”
Furthermore, one of the select areas of the brain involved in neurogenesis, the hippocampus, is also implicated in memory disorders such as Alzheimer’s disease.
“Everyone is so anxious to find something positive for Alzheimer’s – because all the treatment studies since the year 2002 have been failures,” Dr. Baumel said. If this study yields positive findings, the FDA will likely require a placebo-controlled study to demonstrate effectiveness versus a group of patients who do not receive stem cells.
The study is an interdisciplinary collaboration with various Miller School researchers.
“You need a lot of people and expertise involved,” Dr. Baumel said. “UM’s Diabetes Research Institute will help make the cells. Neuropsychologists, immunologists and other experts will all play a role. This is truly a unique effort.”
For more information or to refer a potential candidate to the study, contact Carmen Perez at 305-243-0184 or email firstname.lastname@example.org.