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 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.
The small-scale FDA-cleared trial is designed to evaluate both the safety and initial efficacy of RB-ADSCs in nine patients with Alzheimer’s. Regeneration Biomedical’s CTAD presentation focused on the first three enrolled patients, who each received a single dose of RB-ADSCs delivered directly into the lateral ventricles of the brain using an “Ommaya reservoir” – a device implanted under the scalp to bypass the blood-brain barrier, a major obstacle in Alzheimer’s treatments.
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, 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.
The ongoing Phase 1 trial is an open-label, single-arm study that spans approximately one year, with each participant followed for up to 52 months to monitor longer-term safety and effects. Following the completion of its second dose cohort, the company is now enrolling its final cohort.
“The hope is that our cells will ‘turn on’ the stem cells that are sitting dormant in all of our brains, to initiate repair and replacement of damaged neurons,” Duma told us previously.
