Regeneration Biomedical to Present Phase I Data on Stem Cell Therapy for Alzheimer’s

Regeneration Biomedical, Inc. (RBI), a clinical-stage company focusing on autologous stem cell treatments for neurodegenerative diseases, has announced early data from a Phase 1 clinical trial involving Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) for Alzheimer's Disease (AD). These initial findings will be presented at the Alzheimer's Association International Conference (AAIC) in Philadelphia on July 28, 2024.

Dr. Christopher Duma, president and founder of RBI, highlighted the shortcomings of recently approved anti-beta amyloid antibodies, which only modestly slow cognitive decline while posing significant side effects. RBI's approach is notably different, involving the direct infusion of adipose-derived stem cells into the brain's lateral ventricles to bypass the blood-brain barrier (BBB). Previous in vivo studies have shown that stem cells administered in this manner successfully locate within the ventricles and brain parenchyma. Additionally, a pilot study of an earlier version of their stem cell product yielded promising results in patients with advanced neurodegenerative diseases.

The current Phase 1 trial, which is FDA-cleared, aims to determine the safety of autologous RB-ADSC infused into the lateral ventricles of individuals with mild-to-moderate AD. This open-label, single-arm study plans to enroll nine subjects over about a year. Using a 3 + 3 dose escalation design, the trial will identify a recommended dose for a subsequent Phase 2 clinical trial. Secondary goals include evaluating AD clinical assessments and various biomarkers. Participants will be monitored for up to 12 months post-treatment. The clinical trial is registered under NCT05667649.

RB-ADSC are derived from a patient's own adipose tissue. After collection, the stem cells are cultured and expanded in vitro, selected for Wnt expression—a signaling protein that helps stem cells communicate with each other—and then reintroduced into the patient. This reintroduction is done via an Ommaya reservoir implanted under the scalp, providing direct access to one of the brain's lateral ventricles. Animal model research has shown that these stem cells, once infused into the ventricular system, distribute themselves within the brain parenchyma. Importantly, no safety issues such as inflammation or obstruction of cerebral spinal fluid circulation were observed.

RBI's proprietary therapy leverages a patient's own fat cells to develop a unique Adipose-Derived Stem Cell (ADSC) population. This innovative approach includes a proprietary process of isolation, expansion, and enrichment to manufacture and deliver the therapy directly into the brain.

Regeneration Biomedical, Inc. is dedicated to advancing stem cell therapy for neurodegenerative diseases by utilizing cutting-edge research and clinical applications. Their unique technology focuses on the use of a patient's own adipose-derived stem cells, which are processed and reintroduced to facilitate communication and healing within the brain.