FDA Gives Go-Ahead to Stem Cell Clinical Trial for Alzheimer Disease
The phase 1/2 trial seeks to will assess the safety and efficacy of mesenchymal stem cells for the treatment of Alzheimer disease.
By: Marco Meglio
Published: November 21, 2019
The FDA has approved the phase 1/2 trial of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) designed for the treatment of Alzheimer disease (AD). Hope Biosciences will partner with Altoida, Inc. to leverage biomarkers for detection of mild cognitive impairment (MCI).
“This study will utilize our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments. Our novel technology allows us to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact,” said Donna Chang, president and CEO of Hope Biosciences, in a statement.
The single arm, non-randomized phase 1/2 trial is expected to include 24 patients and will assess the safety and treatment effect of HB-adMSCs in patients with Alzheimer disease. Over an 8-week stretch, patients will receive 4 intravenous infusions of HB-adMSCs, with follow-up evaluations every 6 weeks for 1 year after the last infusion. Each patient will be assessed on the Altoida Neuro Motor Index (NMI) before each infusion and at each follow-up visit.
The Altoida NMI can detect MCI due to Alzheimer 6 to 10 years prior to the onset of symptoms with a 94% accuracy by combining advanced imaging techniques, behavioral assessments, and traditional memory assessments. The application, which is FDA-approved, utilizes augmented reality,machine learning, and digital biomarkers to classify risk for MCI to AD.
“We are convinced that digital biomarkers are the future and will lead to earlier diagnosis, prevention, and better treatments for a wide range of brain diseases,” chief science officer and founder of Altoida, Loannis Tarnanas, PhD, said in a statement.
At the 2019 Alzheimer’s Association International Conference, NeurologyLive spoke with Bernard Baumel, MD, professor of neurology, chief of the cognitive disorders division, and director of memory disorders clinical trials at the University of Miami, who detailed how he and his colleagues are exploring the utility of stem cells in patients with Alzheimer disease.
Hope Biosciences Receives FDA Approval to Commence Groundbreaking Stem Cell Clinical Trial for Alzheimer’s Disease [news release]. Houston, TX: Hope Biosciences. November 20, 2019. businesswire.com/news/home/20191120005240/en. Accessed November 21, 2019.