NCT06775964 · Paul E Schulz
Stem Cell Therapy for Early Alzheimer's Disease
What this study 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.
View original scientific description
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.
Interventions
BIOLOGICAL
adMSC
IV-infusion of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs), of approximately 2x10(8) adMSCs in 250mL saline.
Primary outcome measures
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)
Level of TSPO PET tracer will be measured for each PET scan. TSPO positivity, which is a marker for activated microglia, correlates with neuroinflammation
Inflammatory cytokines in CSF following adMSC therapy
Time frame: Baseline, midpoint (169 days from 1st infusion)
Inflammatory cytokine panel in CSF will be measured using commercially available immunosorbent assays to determine potential treatment effects. Aggregate values and percentages will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has signed an informed consent form before any assessment is performed as part of the study.
- Be male or female between 60 and 80 years old.
- Subject has been or is in process of being clinically diagnosed with late pre-symptomatic or mild cognitive impairment (MCI) due to AD (prodromal AD).
- Mini-Mental State Examination (MMSE) score of ≥ 22
- Has an MRI to evaluate AD pathology (may use previous if within 6mo.)
- Has APOE status to evaluate AD pathology (may use previous result)
- Proficiency in English is required because cognitive tests are administered in English only.
- Has evidence of brain amyloidosis via PET Scan or Aβ42/40 ratios in CSF.
- Has evidence of peripheral inflammatory profile based on CRP (≥ 8 mg/L), IL-6 (≥ 3.1 pg/mL), TNF-α (10 pg/mL), or erythrocyte sedimentation rate (ESR) (≥20 mm/h) in blood assays.
- Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.
Exclusion criteria
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g., traumatic brain injury (TBI), Parkinson's disease (PD), multiple sclerosis, etc.)
- Inability or unwillingness of patient to undergo neuropsychological testing.
- Advanced, severe, progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the subject at special risk. (e.g., significant cardiac disease, severe renal impairment, severe hepatic impairment, autoimmune disease, etc.)
- History of malignancy of any organ system within the past 60 months, that in the opinion of the investigator would impede evaluation or interpretation of subject safety or study results.
- Females of childbearing potential must not be pregnant.
- Inability or unwillingness to undergo PET Scans.
- Inability or unwillingness to undergo MRI Scans.
- Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis
- Positive for TSPO SNP rs6971
- Inability or unwillingness to undergo Lumbar Punctures.
- Inability or unwillingness to undergo infusions.
- Any condition, which in the opinion of the investigator, would put the subject at undue risk or would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Where
- Houston, Texas
Collaborators
Weston Brain Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations