First data emerges from ‘direct-to-brain’ Alzheimer’s stem cell therapy trial

Regeneration Biomedical presents early data showing stem cell treatment reduced levels of p-Tau and amyloid-beta in Alzheimer’s patients.

Last week, at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, stem cell therapy company Regeneration Biomedical, Inc. presented data from the first cohort of the Phase 1 clinical trial of its stem cell therapy for mild-to-moderate Alzheimer’s disease. The therapy aims to deliver the company’s proprietary adipose-derived stem cells (RB-ADSCs) directly to the brain, with the goal of kick-starting the repair and replacement of damaged neurons.

My take on this: In a small FDA-approved trial, Regeneration Biomedical is testing the safety and initial effects of RB-ADSCs in Alzheimer’s patients. Their recent presentation focused on the first three patients, who each received a single dose of the therapy through an “Ommaya reservoir,” a device implanted under the scalp to bypass the blood-brain barrier and deliver the treatment directly to the brain’s ventricles.

Biomarker analysis at the 12-week mark demonstrated reductions in both p-Tau and amyloid-beta – two proteins strongly associated with Alzheimer’s disease progression. In cerebrospinal fluid (CSF) samples from the three patients, p-Tau levels decreased to “normal” levels, while amyloid PET scans also showed a reduction in amyloid buildup.

Regeneration Biomedical also reported its treatment produced signs of cognitive improvement, with two of the three patients showing increased Mini-Mental State Examination (MMSE) scores, a common measure of cognitive function.

The company’s founder Dr Christopher Duma, MD, FACS , who presented the data at the conference, said that “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.”

According to Duma, the treatment also showed a tolerable safety profile with only minor adverse effects, including some discomfort from the liposuction required to collect adipose cells and mild incisional pain from the reservoir implantation. The injection process itself, lasting around eight minutes, required no anesthesia and caused no adverse effects.

Learn more about Regeneration Biomedical and its ongoing trial phase right HERE .

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