-
Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) administered directly into lateral ventricles of the brain were well tolerated and reduced levels of p-Tau and amyloid-beta at 12 weeks
-
Mini-Mental State Examination (MMSE) scores improved in two of three subjects
-
Data presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, 3 to 5 p.m. CET, October 29 and 30, 2024
NEWPORT BEACH, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Regeneration Biomedical, Inc. (“RBI”), a clinical-stage company developing autologous stem cell treatments for neurodegenerative diseases, today announced a presentation on the first dose cohort from a Phase 1 clinical trial of Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) administered directly into lateral ventricles of the brain in patients with Alzheimer’s Disease (AD). The treatment was well tolerated. At 12 weeks, the levels of p-Tau and beta amyloid were reduced. Results of the Mini-Mental State Examination (MMSE) trended toward improved cognition in two of three subjects. The data were presented at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid from 3 to 5 p.m. CET, October 29 and 30, 2024.
“Results from the first dose cohort increase our confidence in the safety of our RB-ADSC product candidate in Alzheimer’s disease patients,” said Christopher Duma, M.D., F.A.C.S., president, founder of RBI and presenter of the data. “In addition, improvements in Alzheimer’s disease biomarkers and an improving trend in a cognitive measure at up to 12 weeks are consistent with our hypothesis that infusion of Wnt-activated stem cells into the brain may initiate a cessation or reversal of at least some of the pathological processes underlying this devastating disease. We have completed enrollment of our second dose cohort and we are progressing enrollment with our third and final dose cohort. We look forward to presenting the full data set at future medical conferences.”
The Phase 1 open-label, single-arm study is enrolling nine subjects over approximately one year randomized into a 3 + 3 single dose escalation design to evaluate the safety of autologous RB-ADSC infused into the lateral ventricles of the brain in subjects with mild-to-moderate AD, and to determine a recommended dose for a potential Phase 2 clinical trial. Secondary endpoints include AD clinical assessments and biochemical and anatomical biomarkers. Each participant will be followed for up to 52 months after treatment. More information on the clinical trial can be found at NCT05667649.