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.
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