Stem Cell Therapy for Early Alzheimer's Disease
ConditionCognitive Dysfunction
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60-80
SponsorPaul E Schulz
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Inability or unwillingness of patient to undergo neuropsychological testing.
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.)
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.
Trial design
Design model
Single group
Treatments tested in this trial
adMSC
Biological/VaccineIV-infusion of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs), of approximately 2x10(8) adMSCs in 250mL saline.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: adMSCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in TSPO levels, measured by the PET scan, from baseline to midpoint and baseline to end of study
Level of TSPO PET tracer will be measured for each PET scan. TSPO positivity, which is a marker for activated microglia, correlates with neuroinflammation
Time frame
Baseline, midpoint (169 days from 1st infusion)2
Inflammatory cytokines in CSF following adMSC therapy
Inflammatory cytokine panel in CSF will be measured using commercially available immunosorbent assays to determine potential treatment effects. Aggregate values and percentages will be reported.
Time frame
Baseline, midpoint (169 days from 1st infusion)Secondary outcomes
1
Number of participants with treatment-related adverse events
Safety endpoints will be monitored throughout the study and number of incidents reported at end of study. Aggregate values and percentages will be reported
Time frame
Baseline - End of Study (337 days from 1st infusion)2
Changes in neurofilament light chain (Nf-L) in CSF following adMSC therapy
Levels of Nf-L in CSF will be measured using commercially available immunosorbent assays to determine potential treatment effects. Aggregate values and percentages will be reported.
Time frame
Baseline, midpoint (169 days from 1st infusion)3
Changes in Glial fibrillary acidic protein (GFAP) in CSF following adMSC therapy
Levels of GFAP in CSF will be measured using commercially available immunosorbent assays to determine potential treatment effects. Aggregate values and percentages will be reported.
Time frame
Baseline, midpoint (169 days from 1st infusion)4
Changes in Total Tau/phosphor-Tau ratios in CSF following adMSC therapy
Levels of Total Tau/phosphor-Tau ratios in CSF will be measured using commercially available immunosorbent assays to determine potential treatment effects. Aggregate values and percentages will be reported.
Time frame
Baseline, midpoint (169 days from 1st infusion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Paul E Schulz
Lead sponsor
The University of Texas Health Science Center, Houston
Sponsor institution
Weston Brain Institute
Collaborator
Source ClinicalTrials.gov