Hope Bio's stem cells going to work in Early Alzheimer’s Disease

Written by Jan Shultis

Billions of stem cells manufactured through proprietary technology by Houston-area biotechnology company Hope Biosciences are soon to be pressed into the fight against Alzheimer’s Disease (AD).

The U.S. Food and Drug Administration (FDA) has authorized an open label Phase Ib/IIa clinical trial to evaluate whether Hope Biosciences autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) reduce inflammation in the brain, improve brain activity, and/or slow progression of AD. Sponsored by the Weston Brain Institute in Canada and conducted at UTHealth Houston, the trial will include twelve patients diagnosed with pre-symptomatic late AD. Each patient will receive four intravenous infusions of approximately 200 million stem cells over a thirteen-week period. Enrollment is expected to begin soon.

“An established and growing body of research demonstrates a direct link between inflammation and progression of Alzheimer’s symptoms,” explains Donna Chang, CEO, Hope Biosciences. “Our technology repeatedly and consistently creates measurable improvements in daily function and quality of life for people suffering from neurodegenerative conditions. We hope to once again demonstrate that our primary technological advantage – repeatable access to high doses of fresh stem cells – opens the door to an efficacious solution for Alzheimer’s.”

AD is often cited as the costliest degenerative condition plaguing the American public, due to both direct healthcare costs and an extreme need for caretaking that increases over time, in addition to tangential impacts such as workforce losses. AD is a disorder that atrophies the brain, progressively disrupting memory, cognition, and behavior. An estimated 6.9 million Americans aged 65 and older are living with Alzheimer’s disease dementia, according to the Alzheimer’s Association.

“In Alzheimer’s, deposits of beta-amyloid and tau lead to the buildup of plaques and tangles in the brain, which cause dementia,” elaborates Paul E. Schulz, MD, principal investigator, professor of neurology, and director of the Neurocognitive Disorders Center in McGovern Medical School at UTHealth Houston. “The beta-amyloid and tau protein come first in the disease, often for decades, followed by inflammation, which leads to cell death. While there are currently good medications available to get rid of the amyloid and slow the progression of the disease, we cannot yet stop it. We believe progression continues 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 pre-symptomatic individuals.”

This trial continues a series of collaborations between UTHealth Houston and Hope Biosciences, who have previously conducted two trials in traumatic brain injury. Positive preliminary results in those trials contributed to development of the current AD trial, due to some commonalities in the way inflammation affects the brain in each condition, and expected similarities in how the stem cell may act on sick and suffering brains and people.

“We remain hopeful,” concludes Chang. “Our technology continues to help real people, with real needs, right now. It is a privilege to reach twelve more such people through this trial, and continue promising work with respected partners.”

Headquartered in Sugar Land, Texas (west of Houston) and now in its ninth year of operation, to date MSCs cultured at Hope Biosciences have been used in more than 45 FDA-authorized clinical studies. Clinical trials encompass COVID-19 prevention and treatment, “Long Haul” COVID, Parkinson’s Disease, multiple sclerosis (MS), and traumatic brain injury. Expanded access protocols include nervous system conditions such as amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), cerebral palsy, spinal cord injury, polyneuropathy, and muscular dystrophy; as well as immune conditions such as lupus; chronic musculoskeletal pain, severe osteoarthritis, rheumatoid arthritis, and psoriatic arthritis; and breast and pancreatic cancers.

For more information about Hope Biosciences, visit hope.bio. For more information on the study, please visit the memory disorders research page at UTHealth Houston.