Stem Cell Therapy Under Study for Stabilizing Alzheimer’s Progression

A clinical trial at the University of Miami Miller School of Medicine is investigating the potential of a single infusion of mesenchymal stem cells, in conjunction with standard anti-amyloid therapy, to stabilize cognitive decline in individuals with early Alzheimer’s disease and mild cognitive impairment. This study builds on the foundation of emerging standard-of-care anti-amyloid treatments and previous phase I research involving Lomecel-B, a therapy based on mesenchymal stem cells. The trial seeks to ascertain whether the addition of stem cells to established treatments can halt or significantly slow further cognitive deterioration, aiming for disease stabilization rather than simply delaying symptom progression.

According to Precedence Research, the global stem cell therapy for neurological disorders market was valued at USD 2.38 billion in 2025 and is projected to grow from USD 2.81 billion in 2026 to approximately USD 12.67 billion by 2035, expanding at a CAGR of 17.90% from 2026 to 2035, driven by the rising neurological disorder prevalence.

Potential of Mesenchymal Stem Cell Infusion to Enhance Early Alzheimer’s Treatment Outcomes

The study focuses on early-stage Alzheimer’s patients who are currently receiving anti-amyloid monoclonal antibodies, specifically Leqembi or Kisunla. These treatments help to eliminate amyloid plaques and slow the progression of the disease, though they do not halt it entirely. The research includes a one-time intravenous infusion of human mesenchymal stem cells to evaluate the potential for stabilizing or improving cognitive decline. This stem cell therapy is administered after six months of antibody treatment to reduce any confounding safety issues.

Dual-Target Approach

The study highlights that Alzheimer’s disease is characterized by both amyloid accumulation and neuroinflammation. Although the removal of amyloid can diminish inflammation and slow disease progression, mesenchymal stem cells may offer an additional strategy through their immunomodulatory and regenerative properties. These stem cells migrate to sites of injury, release anti-inflammatory molecules, and facilitate tissue repair. This combined approach targeting both amyloid burden and inflammation underpins the hypothesis of the trial.

Early Lomecel-B Evidence Supports Combined Alzheimer’s Therapy

A previous Phase I trial of Lomecel-B in patients with mild Alzheimer’s disease involved a single intravenous infusion of either stem cells or a placebo, conducted in a randomized, double-blind format that prioritized safety. Notably, there were no serious adverse events related to the treatment. Exploratory findings indicated cognitive stabilization or improvement at lower doses, along with positive inflammatory and vascular biomarkers. The current trial builds on this foundation by integrating stem cell therapy with standard anti-amyloid treatment. These days, finding further support for the growing potential of stem cell-based approaches in neurological disease management

A recent report by Precedence Research highlights that the stem cell therapy for neurological disorders market is benefiting from the rise of stem cell innovation and clinical trials.