Stem Cell Therapy for Early Alzheimer's Disease

Launched by PAUL E SCHULZ · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether stem cell therapy can help treat brain inflammation in adults who are experiencing early signs of Alzheimer's disease. The researchers believe that reducing inflammation in the brain might improve memory and thinking abilities and slow down the progression to Alzheimer's. If you join the trial, a small sample of fat will be taken from your body to extract stem cells, which will then be returned to you through four infusions over a 12-week period. You'll also have regular check-ups at the clinic during and after the treatment to monitor your health.

To be eligible for this trial, you need to be between 60 and 80 years old and have mild cognitive impairment, which means you may have some memory or thinking problems. You’ll also need to pass certain tests to ensure that you qualify. If you decide to participate, you will be part of an important study that aims to find new ways to help people with Alzheimer's disease. Please note that the trial is not yet recruiting participants, so there might be a wait before you can join.

Gender

ALL

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.