A stem cell therapy trial aimed at reducing neuroinflammation in patients with presymptomatic Alzheimer’s disease is underway at UTHealth Houston.
In Alzheimer’s disease, deposits of beta-amyloid and tau lead to the buildup of plaques and tangles in the brain, which cause dementia. An estimated 6.9 million Americans age 65 and older are living with Alzheimer’s disease dementia, according to the Alzheimer’s Association.
The beta-amyloid and tau protein come first in the disease, often for decades, followed by inflammation, which leads to cell death. We have good medications to get rid of the amyloid and slow the progression of the disease, but not stop it. We believe it’s not stopped because the downstream damage from inflammation has been set in motion. So, if we can get rid of both the beta-amyloid and decrease the inflammation, we may be able to preclude or significantly reduce the risk of getting Alzheimer’s disease.”
Paul E. Schulz, MD, principal investigator, professor of neurology, and director of the Neurocognitive Disorders Center in McGovern Medical School at UTHealth Houston
In this Phase Ib/IIa open label study, the stem cells are taken from the patient’s own fat, processed by a Sugar Land company, Hope Biosciences, and given back to the patient in four infusions over 13 weeks. The trial, which is sponsored by Weston Brain Institute in Canada, will enroll 12 patients. PET imaging sensitive to inflammation in the brain will be used to determine whether stem cells reduce the main cause of brain cell loss in Alzheimer’s disease prior to the development of symptoms. Co-investigators are Javier Ortiz IV, PhD, assistant professor of neurology, and Harshali Patel, clinical research coordinator.
The study builds on previous UTHealth Houston stem cell research for traumatic brain injury (TBI) and stroke, which led to preclinical research in animal models of Parkinson’s disease and Alzheimer’s disease.
“With TBI and stroke, the blood-brain barrier opens up, so we weren’t sure the stem cells could help in a neurodegenerative disease where the blood-brain barrier remains closed. But inflammation seems to be the final item that leads to cell death,” said Schulz, who is the Rick McCord Professor in Neurology and the Umphrey Family Professor in Neurodegenerative Diseases. “So UTHealth Houston researchers began to look in mouse models of Parkinson’s disease to test whether intravenous stem cells would have an effect. They found that by giving them stem cells, the treated mice continued acting as normal mice.”
The Parkinson’s animal model study was led by Claudio Soto, PhD, the Huffington Foundation Distinguished Chair in Neurology and professor of neurology at McGovern Medical School.
Another study on stem cells in mice with Alzheimer’s disease changes, also led by Soto, revealed that the animals’ memories were preserved and there was a reduction of inflammation in the brain. This makes Schulz and his team very hopeful that this study will show that stem cell therapy in humans with presymptomatic Alzheimer’s disease can reduce the risk of developing the clinical symptoms of the disease.
For more information on the study, please visit the memory disorders research page.
A stem cell therapy trial aimed at reducing neuroinflammation in patients with presymptomatic Alzheimer’s disease is underway at UTHealth Houston.
In Alzheimer’s disease, deposits of beta-amyloid and tau lead to the buildup of plaques and tangles in the brain, which cause dementia. An estimated 6.9 million Americans age 65 and older are living with Alzheimer’s disease dementia, according to the Alzheimer’s Association.
“The beta-amyloid and tau protein come first in the disease, often for decades, followed by inflammation, which leads to cell death,” said Paul E. Schulz, MD, principal investigator, professor of neurology, and director of the Neurocognitive Disorders Center in McGovern Medical School at UTHealth Houston. “We have good medications to get rid of the amyloid and slow the progression of the disease, but not stop it. We believe it’s not stopped because the downstream damage from inflammation has been set in motion. So, if we can get rid of both the beta-amyloid and decrease the inflammation, we may be able to preclude or significantly reduce the risk of getting Alzheimer’s disease.”
In this Phase Ib/IIa open label study, the stem cells are taken from the patient’s own fat, processed by a Sugar Land company, Hope Biosciences, and given back to the patient in four infusions over 13 weeks. The trial, which is sponsored by Weston Brain Institute in Canada, will enroll 12 patients. PET imaging sensitive to inflammation in the brain will be used to determine whether stem cells reduce the main cause of brain cell loss in Alzheimer’s disease prior to the development of symptoms. Co-investigators are Javier Ortiz IV, PhD, assistant professor of neurology, and Harshali Patel, clinical research coordinator.
The study builds on previous UTHealth Houston stem cell research for traumatic brain injury (TBI) and stroke, which led to preclinical research in animal models of Parkinson’s disease and Alzheimer’s disease.
“With TBI and stroke, the blood-brain barrier opens up, so we weren’t sure the stem cells could help in a neurodegenerative disease where the blood-brain barrier remains closed. But inflammation seems to be the final item that leads to cell death,” said Schulz, who is the Rick McCord Professor in Neurology and the Umphrey Family Professor in Neurodegenerative Diseases. “So UTHealth Houston researchers began to look in mouse models of Parkinson’s disease to test whether intravenous stem cells would have an effect. They found that by giving them stem cells, the treated mice continued acting as normal mice.”
The Parkinson’s animal model study was led by Claudio Soto, PhD, the Huffington Foundation Distinguished Chair in Neurology and professor of neurology at McGovern Medical School.
Another study on stem cells in mice with Alzheimer’s disease changes, also led by Soto, revealed that the animals’ memories were preserved and there was a reduction of inflammation in the brain. This makes Schulz and his team very hopeful that this study will show that stem cell therapy in humans with presymptomatic Alzheimer’s disease can reduce the risk of developing the clinical symptoms of the disease.
For more information on the study, please visit the memory disorders research page.
Source:
University of Texas Health Science Center at Houston
