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Trial Underway Testing Stem Cells to Treat Alzheimer’s

Brain synapses illustration

(Allan Ajifo, Wikimedia Commons)

27 July 2016. An intermediate-stage clinical trial is recruiting participants to test donated stem cells as a treatment for mild to moderate dementia from Alzheimer’s disease. The study is conducted at Emory University in Atlanta and University of California in Irvine, by the developer, Stemedica Cell Technologies Inc., based in San Diego.

Alzheimer’s disease is progressive neurodegenerative disease affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta peptides, as well as misfolded tangles of proteins inside brain cells known as tau. The Alzheimer’s Association says some 5.4 million individuals in the U.S. have the disorder, of which 5.2 million are age 65 or older. By 2050 that number is expected to increase to 13.8 million.

Stemedica develops treatments for cardiovascular, neurological, skin, and vision disorders with mesenchymal or adult stem cells. The company says its culturing methods in a low-oxygen environment simulates conditions inside the body, and yields larger quantities of stem cells with consistent quality for therapies. In addition, says Stemedica, its stem cells, harvested from brain tissue donations, differentiate or transform into neurons or supporting glial cells in the brain, and produce the main characteristics and traits in the nervous system

The clinical trial plans to enroll 40 participants, age 55 and over, with mild to moderate dementia, and exhibiting Alzheimer’s disease symptoms for at least 3 months meeting criteria set by National Institute of Neurological and Communicative Disorders and Stroke at National Institutes of Health, and the Alzheimer’s Disease and Related Disorders Association. The main objective of the trial is to test for safety over 18 months, but it will also look for indications of efficacy. 

Participants will be randomly assigned to receive a single dose infusion of Stemedica stem cells or a placebo. After 6 months, the groups will be reversed, so individuals first receiving a placebo will instead be given stem cells, and vice-versa. Safety and tolerability will be assessed by reports of adverse events, while efficacy will be evaluated with neurological, functional, and psychiatric tests.

In preclinical studies, Stemedica stem cells demonstrated a 30 percent reduction in amyloid beta plaques in the brains of lab animals induced with Alzheimer’s disease, compared to a placebo. In addition, no serious side effects, such as hemorrhages in the brain or deposits of amyloid beta plaques in blood vessels were reported.

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