Actively Recruiting
Stem Cell Therapy for Early Alzheimer's Disease
Led by Paul E Schulz · Updated on 2026-04-20
12
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
Sponsors
P
Paul E Schulz
Lead Sponsor
W
Weston Brain Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Stem Cell Therapy for Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study assessment
- Male or female aged between 60 and 80 years
- Clinically diagnosed or being diagnosed with late pre-symptomatic or mild cognitive impairment due to Alzheimer's disease
- Mini-Mental State Examination (MMSE) score of 22 or higher
- MRI scan to evaluate Alzheimer's pathology (recent within 6 months or new scan)
- APOE genetic status available for Alzheimer's evaluation
- Proficiency in English to complete cognitive tests
- Evidence of brain amyloidosis confirmed by PET scan or cerebrospinal fluid tests
- Evidence of peripheral inflammation based on blood tests: CRP ≥ 8 mg/L, IL-6 ≥ 3.1 pg/mL, TNF-α ≥ 10 pg/mL, or erythrocyte sedimentation rate ≥ 20 mm/h
- Considered in good general medical health by the investigator based on history, exams, labs, vital signs, and EKG
You will not qualify if you...
- Current medical or neurological conditions impacting cognition or cognitive testing (e.g., traumatic brain injury, Parkinson's disease, multiple sclerosis)
- Unable or unwilling to undergo neuropsychological testing
- Advanced, severe, progressive, or unstable diseases that could affect safety or study assessments (e.g., serious cardiac, kidney, liver, or autoimmune diseases)
- History of cancer within the past 60 months that may affect safety or study results
- Females of childbearing potential who are pregnant
- Unable or unwilling to undergo PET scans
- Unable or unwilling to undergo MRI scans
- Positive blood tests for HIV, Hepatitis B, Hepatitis C, or Syphilis
- Positive for TSPO SNP rs6971 genetic variant
- Unable or unwilling to undergo lumbar punctures
- Unable or unwilling to receive intravenous infusions
- Any condition judged by the investigator to pose undue risk or interfere with study evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston (UTHealth)
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
H
Harshali Patel
CONTACT
J
Javier Ortiz, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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