NCT06781333

Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to the Treatment of Patients Suffering Agitation/Aggression or Other Behavioral Abnormalities From Alzheimer's Disease.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Bernard (Barry) Baumel · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.

Conditions

• Alzheimer Disease
• Agitation in Dementia

Interventions

Type	Name	Description
BIOLOGICAL	hMSC	Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.

Timeline

• Start date: 2025-04-29
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2025-01-17
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study