RECRUITING

Stem Cell Therapy for Early Alzheimer's Disease

Conditions

Cognitive Dysfunction Mild Cognitive Impairment Cognitive Decline Alzheimer's disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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

Official Title

Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease

Quick Facts

Study Start:2025-07

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06775964

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Has signed an informed consent form before any assessment is performed as part of the study. 2. Be male or female between 60 and 80 years old. 3. 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). 4. Mini-Mental State Examination (MMSE) score of ≥ 22 5. Has an MRI to evaluate AD pathology (may use previous if within 6mo.) 6. Has APOE status to evaluate AD pathology (may use previous result) 7. Proficiency in English is required because cognitive tests are administered in English only. 8. Has evidence of brain amyloidosis via PET Scan or Aβ42/40 ratios in CSF. 9. 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. 10. Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.	1. 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.) 2. Inability or unwillingness of patient to undergo neuropsychological testing. 3. 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.) 4. 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. 5. Females of childbearing potential must not be pregnant. 6. Inability or unwillingness to undergo PET Scans. 7. Inability or unwillingness to undergo MRI Scans. 8. Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis 9. Positive for TSPO SNP rs6971 10. Inability or unwillingness to undergo Lumbar Punctures. 11. Inability or unwillingness to undergo infusions. 12. 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.

Inclusion Criteria

Exclusion Criteria

1. Has signed an informed consent form before any assessment is performed as part of the study.
2. Be male or female between 60 and 80 years old.
3. 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).
4. Mini-Mental State Examination (MMSE) score of ≥ 22
5. Has an MRI to evaluate AD pathology (may use previous if within 6mo.)
6. Has APOE status to evaluate AD pathology (may use previous result)
7. Proficiency in English is required because cognitive tests are administered in English only.
8. Has evidence of brain amyloidosis via PET Scan or Aβ42/40 ratios in CSF.
9. 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.
10. Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.

1. 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.)
2. Inability or unwillingness of patient to undergo neuropsychological testing.
3. 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.)
4. 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.
5. Females of childbearing potential must not be pregnant.
6. Inability or unwillingness to undergo PET Scans.
7. Inability or unwillingness to undergo MRI Scans.
8. Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis
9. Positive for TSPO SNP rs6971
10. Inability or unwillingness to undergo Lumbar Punctures.
11. Inability or unwillingness to undergo infusions.
12. 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.

Contacts and Locations

Study Contact

Harshali Patel

CONTACT

713-486-0531

Harshali.Patel@uth.tmc.edu

Javier Ortiz, PhD

CONTACT

713-486-0505

Guadalupe.J.Ortiz@uth.tmc.edu

Principal Investigator

Paul E Schulz, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

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

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Paul E Schulz

Paul E Schulz, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2027-01

Study Record Updates

Study Start Date2025-07

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

Mild Cognitive Impairment
Cognitive Decline
Alzheimer's disease

Additional Relevant MeSH Terms

Cognitive Dysfunction