Stem Cell Therapy for Early Alzheimer's Disease

Part of paid clinical trials in Houston, Texas.

Sponsor
Paul E Schulz
Study ID
NCT06775964
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cognitive Dysfunction

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • adMSC — BIOLOGICAL
    IV-infusion of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs), of approximately 2x10(8) adMSCs in 250mL saline.

Study Details

The goal of this clinical trial is to learn if stem cell therapy works to treat brain inflammation in adults. Inflammation in the brain may be involved in adults who have memory or thinking problems. The stem cells will be taken from participant's fat samples, processed and given back to participants, so they are their own donor. The main questions this trial aims to answer are: * Does stem cell therapy reduce inflammation in the brain? * Does stem cell therapy improve brain activity? * Does stem cell therapy slow down progression to Alzheimer's disease? Participants will: * Have a small fat biopsy taken at a doctor's office to process stem cells * Receive 4 infusions of stem cells, through a vein in the arm over 12 weeks * Visit the clinic every 2-4 weeks for the first 4 months and then every 1-2 months for 8 months for checkups and tests

Key Dates

Start date
Mar 11, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

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

Arms

  • Experimental: adMSC
    IV-infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs)

Primary Outcome Measure

Change in TSPO levels, measured by the PET scan, from baseline to midpoint and baseline to end of study [ Time Frame: Baseline, midpoint (169 days from 1st infusion) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at Houston (UTHealth)HoustonTexas77054
Javier Ortiz, PhD
[email protected]
713-486-0505
Christine Farrell, PhD
[email protected]
713-486-0527

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By research site
The University of Texas Health Science Center at Houston (UTHealth)· Houston, TX

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