RecruitingPhase 1Phase 2NCT06775964

Stem Cell Therapy for Early Alzheimer's Disease

Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease


Sponsor

Paul E Schulz

Enrollment

12 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing stem cell therapy for people in the early stages of Alzheimer's disease — specifically those with mild cognitive impairment (early memory and thinking problems linked to Alzheimer's). Researchers want to find out if stem cells can slow or reverse these early changes in the brain. **You may be eligible if...** - You are between 60 and 80 years old - You have been diagnosed with mild cognitive impairment or early Alzheimer's disease - Your cognitive score (MMSE) is 22 or higher (mild impairment range) - You have brain scans or fluid tests showing Alzheimer's-related protein changes (amyloid) - You have elevated blood markers of inflammation (CRP, IL-6, TNF-α) - You have an APOE genetic test result on file or are willing to get one - You are proficient in English (cognitive tests are in English) **You may NOT be eligible if...** - You have moderate or severe Alzheimer's (MMSE below 22) - You do not have evidence of amyloid changes in the brain - You are not able to complete English-language cognitive testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALadMSC

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


Locations(1)

The University of Texas Health Science Center at Houston (UTHealth)

Houston, Texas, United States

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NCT06775964


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