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Stem Cell Therapy for Early Alzheimer's Disease

RecruitingPhase 1, Phase 2

Sponsor: Paul E Schulz

Conditions: Cognitive Dysfunction

Interventions: adMSC

Countries: United States

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 overview

Sex: ALL

Age: 60 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

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.

Locations (1)

Houston, Texas, United States