Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
United States
Texas
The University of Texas Health Science Center at Houston (UTHealth)
RECRUITING
Houston
Contact Information
Primary
Harshali Patel
Harshali.Patel@uth.tmc.edu
713-486-0531
Backup
Javier Ortiz, PhD
Guadalupe.J.Ortiz@uth.tmc.edu
713-486-0505
Time Frame
Start Date: 2025-07
Estimated Completion Date: 2027-01
Participants
Target number of participants: 12
Treatments
Experimental: adMSC
IV-infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs)
Sponsors
Leads: Paul E Schulz
Collaborators: Weston Brain Institute

This content was sourced from clinicaltrials.gov