Regeneration Biomedical recently presented early data on its stem cell therapy for Alzheimer's disease at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid.

The Phase 1 clinical trial, which is FDA-cleared, involves nine patients and focuses on using adipose-derived stem cells (RB-ADSCs) to repair and replace damaged neurons in individuals with mild-to-moderate Alzheimer's.

This ongoing open-label, single-arm trial will monitor participants for up to 52 months to assess long-term safety and efficacy, with the company currently enrolling its final cohort after completing the second dosage group.

The treatment is administered directly into the lateral ventricles of the brain via an Ommaya reservoir, effectively bypassing the blood-brain barrier.

The treatment has shown a tolerable safety profile, with only minor side effects associated with the liposuction procedure and reservoir implantation, and no adverse effects from the injection itself.

Cognitive improvements were observed, with two of the three patients showing increased Mini-Mental State Examination (MMSE) scores, indicating enhanced cognitive function.

At the 12-week mark, biomarker analysis revealed reductions in p-Tau and amyloid-beta, proteins associated with Alzheimer's progression, with p-Tau levels returning to normal.

Additionally, amyloid PET scans confirmed a decrease in amyloid buildup in the patients' brains.

Dr. Christopher Duma, the company’s founder, emphasized that these results support the hypothesis that Wnt-activated stem cells may help alleviate some pathological processes of Alzheimer's.