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RecruitingPhase 1 / Phase 2

Stem Cell Therapy for Early Alzheimer's Disease

Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 8 months
  • Procedures mentioned: Biopsies, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "This is a Phase 1b/2a open label study to assess the safety and tolerability, as well as reduction of neuroinflammation after four IV-infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs) over a 13-week treatment period in 12 subjects who are clinically diagnosed with late pre-symptomatic or prodromal AD, exhibit an Alzheimer's pathology and peripheral inflammatory profile."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether stem cells from a person's own fat can reduce brain inflammation, improve brain activity, and slow the move toward Alzheimer's disease. It is for adults ages 60–80 with very early Alzheimer's disease or mild memory or thinking problems due to Alzheimer's. Participants will have a small fat sample taken and receive 4 stem cell treatments through an arm vein over 12 weeks, with checkups over 12 months.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before any study tests.
  • Be 60–80 years old.
  • Have, or be getting checked for, very early Alzheimer's before clear symptoms or mild memory or thinking problems due to Alzheimer's.
  • Score at least 22 on the MMSE, a memory and thinking test, and know enough English to take tests in English.
  • Have a brain MRI scan and an APOE gene test result. An MRI from the past 6 months and a past gene test result may be used.
  • Have signs of amyloid protein buildup in the brain, shown by a PET scan or a test of fluid around the brain and spinal cord.
  • Have blood test results showing inflammation at the levels required by the study.
  • Be in good overall health, based on the study doctor's review, exam, and tests.

Who can't join

  • Have another health or brain condition that could affect thinking or test results, such as a brain injury, Parkinson's disease, or multiple sclerosis.
  • Cannot or do not want to take memory and thinking tests, have PET or MRI scans, receive treatments through a vein, or have spinal taps to collect fluid from the lower back.
  • Have a serious, worsening, or unstable illness that could make the study unsafe or affect results.
  • Have had cancer in the past 5 years that the study doctor thinks could affect safety checks or study results.
  • Be pregnant.
  • Have a positive blood test for HIV, hepatitis B, hepatitis C, or syphilis.
  • Test positive for a gene change called TSPO SNP rs6971.
  • Have any other condition that the study doctor thinks could cause too much risk or affect study results.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX