The FDA has approved a new Phase I/II clinical trial evaluating the safety and efficacy of an autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) for Alzheimer’s Disease sponsored by Hope Biosciences in partnership with Altoida Inc., a predictive digital biomarker company.
The study will utilize the sponsor’s core proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments. Hope Bioscience’s novel technology affords them to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact. We can produce, on-demand, over 1,000 highly concentrated HB-adMSC treatments from a single tablespoon of the patient’s own fat tissue.
This technology eliminates potential donor rejection and donor rejection and donor-to-donor variability. They expect HB-adMSC’s to safely and effectively diminish the effects of Alzheimer’s Disease and offer patients more time with better cognitive function.
This Phase I/II study is a single arm, non-randomized study that is expected to enroll 24 participants. The study’s primary objective is to determine the safety and treatment effect of HB-adMSCs for treatment of Alzheimer’s Disease. HB-adMSCs are administered via four intravenous infusions over an eight-week period and follow-up evaluations every 6 weeks after the last infusion for one year. Assessments with Altoida NMI will be performed prior to each infusion and at each follow-up visit thereafter. HB-adMSCs are autologous and have an established safety profile.
No Alzheimer’s Treatments
Currently there are no therapies clinically proven to slow the progression of Alzheimer’s Disease or restore cognitive functions and the sponsor is confident this can be accomplished.
Chronic neurodegenerative diseases like Alzheimer’s Disease have underlying neuroinflammation which contributes to deposition of amyloid plaques and tau tangles. Advanced imaging techniques reveal localization of amyloid in the brain, which can be monitored in serial imaging over time. Behavioral assessments are often used to detect disease progression by focusing on a variety of memory tasks. Traditional memory assessments are generally helpful; however, they lack the sensitivity to detect subtle changes in different types of memory and cognitive function.
Enter Novel Digital Detection
Altoida, Inc. has created a powerful application that utilizes augmented reality (AR), machine learning (ML) and active Digital Biomarkers to classify patient’s risk for Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD). Altoida’s novel technology, the Altoida Neuro Motor Index (NMI), is a Medical Device which detects MCI due to AD 6-10 years prior to the onset of symptoms and with a 94% accuracy. The gamified collection of functional and cognitive data by utilizing tablet or smartphone sensors takes 10min only and is the world’s first cognitive measurement of micro errors with active digital biomarkers. Altoida NMI is commercially available in all major global healthcare markets and is both, FDA and CE approved.
“Altoida is at the forefront of a new era to leverage Artificial Intelligence and Machine Learning to assess brain health,” said Dr. Richard Fischer, CEO & President of Altoida Inc. “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. Altoida stands for deepening our understanding of brain health and will have a transformative impact on medicine and society,” said CSO & Founder Dr. Ioannis Tarnanas.
About Hope Biosciences
Hope Biosciences is a clinical stage biotechnology company focused on developing novel cell-based therapeutics for acute and chronic injury and disease. Hope Bio’s core technology lies in stem cell culture and banking. Mesenchymal stem cells are isolated from approximately one tablespoon of a patient’s own fat tissue, purified, and cultured with Hope Bio’s proprietary culture media, HB-101. HB-adMSCs are expanded to multiple passages and released at Passage 4 for therapeutic use. Samples of each passage are banked in order to create a master cell bank for each patient, which will be used to make additional therapies in the future. HB-adMSCs have already been used as a safe and effective treatment in a Phase I/IIa clinical trial for Rheumatoid Arthritis and Individual Expanded Access IND for Parkinson’s disease, Cerebral Palsy, Spinal Cord Injury, Pancreatic Cancer, and Thrombotic Thrombocytopenic Purpura.Source: Hope Biosciences