Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.

Part of paid clinical trials in Miami, Florida.

Sponsor
Bernard (Barry) Baumel
Study ID
NCT07512362
Phase
PHASE2
Status
Recruiting
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Conditions

  • AD-MCI
  • Early Alzheimer's Disease
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • human Mesenchymal Stem Cells — BIOLOGICAL
    Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.

Study Details

The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.

Key Dates

Start date
May 15, 2026
Status verified
May 2026
Primary completion
Jun 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mesenchymal Stem Cell Infusion
    Patients will receive one infusion of 25 million of human mesenchymal stem cells in the vein.

Primary Outcome Measure

Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) [ Time Frame: Baseline, Week 16, Week 32, and Week 48 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Department of NeurologyMiamiFlorida33136
Maria E. Puertas, CRC
[email protected]
(305) 243-3100
Bernard S Baumel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami Department of Neurology· Miami, FL

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