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Adipose-Derived Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease (NCT06775964)
Study Overview
| Field | Value |
|-------|-------|
| NCT Number | [NCT06775964](https://clinicaltrials.gov/study/NCT06775964) |
| Title | Stem Cell Therapy for Early Alzheimer's Disease |
| Phase | Phase 1b/2a |
| Status | RECRUITING |
| Sponsor | Paul E Schulz, MD (UTHealth Houston) |
| Collaborator | Weston Brain Institute |
| Location | UT Health Science Center at Houston, TX |
| Enrollment | 12 subjects (estimated) |
| Start Date | February 2026 |
| Primary Completion | December 2026 |
| Study Completion | January 2027 |
Study Design
This is a Phase 1b/2a open-label, single-arm study evaluating the safety, tolerability, and efficacy of autologous, adipose-derived mesenchymal stem cells (adMSCs) in adults with late pre-symptomatic or prodromal Alzheimer's disease.
Rationale
Most currently approved AD drugs primarily treat symptoms. While anti-amyloid antibodies have successfully reduced amyloid burden, they have only modestly affected cognitive progression. This suggests that other pathological pathways are equally important for AD progression.
Study Overview
| Field | Value |
|-------|-------|
| NCT Number | [NCT06775964](https://clinicaltrials.gov/study/NCT06775964) |
| Title | Stem Cell Therapy for Early Alzheimer's Disease |
| Phase | Phase 1b/2a |
| Status | RECRUITING |
| Sponsor | Paul E Schulz, MD (UTHealth Houston) |
| Collaborator | Weston Brain Institute |
| Location | UT Health Science Center at Houston, TX |
| Enrollment | 12 subjects (estimated) |
| Start Date | February 2026 |
| Primary Completion | December 2026 |
| Study Completion | January 2027 |
Study Design
This is a Phase 1b/2a open-label, single-arm study evaluating the safety, tolerability, and efficacy of autologous, adipose-derived mesenchymal stem cells (adMSCs) in adults with late pre-symptomatic or prodromal Alzheimer's disease.
Rationale
Most currently approved AD drugs primarily treat symptoms. While anti-amyloid antibodies have successfully reduced amyloid burden, they have only modestly affected cognitive progression. This suggests that other pathological pathways are equally important for AD progression.
Neuroinflammation has emerged as a critical player in AD pathogenesis. Evidence includes:
- Elevated inflammatory markers in patients at different clinical stages of AD
- Identification of AD risk genes associated with innate immune functions
- Strong correlation between microglial activation and disease progression
This study targets neuroinflammation directly using mesenchymal stem cells, which exhibit multi-therapeutic effects:
- Anti-inflammatory properties
- Reduced amyloid-β activity
- Promotion of neurogenesis
- Low immunogenicity (autologous = patient-derived)
Intervention
Biological: adMSC — IV-infusion of autologous, adipose-derived mesenchymal stem cells (adMSCs), approximately 2×10⁸ cells in 250mL saline.
Dosing Schedule:
- 4 IV infusions over 12 weeks
- Infusions administered through a vein in the arm
Eligibility Criteria
Inclusion Criteria
- CRP ≥ 8 mg/L
- IL-6 ≥ 3.1 pg/mL
- TNF-α ≥ 10 pg/mL
- ESR ≥ 20 mm/h
Exclusion Criteria
Outcome Measures
Primary Outcomes
| Measure | Description | Timeframe |
|---------|-------------|-----------|
| Change in TSPO levels | Measured by PET scan from baseline to midpoint and end of study | Baseline, Day 169 |
| Inflammatory cytokines in CSF | Cytokine panel measured via ELISA | Baseline, Day 169 |
TSPO (Translocator Protein) is a marker for activated microglia. TSPO PET imaging correlates with neuroinflammation levels in the brain.
Secondary Outcomes
| Measure | Description | Timeframe |
|---------|-------------|-----------|
| Treatment-related adverse events | Safety monitoring throughout study | Baseline - Day 337 |
| Neurofilament light chain (Nf-L) in CSF | Neurodegeneration biomarker | Baseline, Day 169 |
| GFAP in CSF | Astrocyte activation marker | Baseline, Day 169 |
| Total Tau/phospho-Tau ratios in CSF | AD progression markers | Baseline, Day 169 |
| FDG PET imaging | Cerebral metabolism activity | Baseline, Day 169 |
| Amyloid-β 42/40 ratio in CSF | Amyloid pathology marker | Baseline, Day 169 |
| MMSE score | Cognitive function | Baseline, Day 337 |
| RBANS scores | Neuropsychological assessment | Baseline, Day 337 |
| Lawton IADL Scale | Functional independence | Baseline, Day 337 |
| Immune pathway markers in blood | Systemic inflammation | Baseline, Day 169, Day 337 |
| Immune pathway markers in CSF | CNS inflammation | Baseline, Day 169 |
Clinical Endpoints
Cognitive Measures
- MMSE (Mini-Mental State Examination): Scoring ranges from 0-30
- 24-30: No cognitive impairment
- 18-23: Mild cognitive impairment
- 0-17: Severe cognitive impairment
- RBANS (Repeatable Battery for the Assessment of Neuropsychological Status)
- Total scores range from 40 to 160 (mean 100, SD 15)
- ≥70: Average/Mild Impairment
- 55-69: Moderate Impairment
- <54: Severe Impairment
- Lawton IADL Scale: Measures instrumental activities of daily living
- Women: 0-8 scale (8 = independent)
- Men: 0-5 scale (5 = independent)
Biomarker Endpoints
| Biomarker | Tissue | Significance |
|-----------|--------|--------------|
| TSPO | PET | Microglial activation / neuroinflammation |
| Nf-L | CSF | Axonal neurodegeneration |
| GFAP | CSF | Astrocyte activation |
| Total Tau | CSF | Neurodegeneration |
| Phospho-Tau | CSF | Tau pathology |
| Aβ42/40 | CSF | Amyloid pathology |
| FDG PET | Brain | Cerebral glucose metabolism |
Scientific Context
Neuroinflammation in AD
The brain's immune system plays a dual role in Alzheimer's disease. While initially protective, chronic neuroinflammation drives disease progression through:
- Continuous microglial activation producing pro-inflammatory cytokines
- Impaired clearance of amyloid-β and tau
- Synaptic dysfunction and neuronal loss
- Spread of pathology across brain networks
TSPO as a Biomarker
Translocator protein (TSPO, 18kDa) is expressed primarily on activated microglia and peripheral immune cells. TSPO PET imaging provides:
- In vivo measurement of microglial activation
- Quantification of neuroinflammation burden
- Potential for monitoring treatment response
Mesenchymal Stem Cells for Neurodegeneration
Adipose-derived MSCs offer several advantages:
- Autologous source: Eliminates immune rejection risk
- Multi-modal action: Anti-inflammatory, anti-amyloid, pro-neurogenic
- Low immunogenicity: Reduced GVHD risk
- Easy harvesting: Minimally invasive fat tissue collection
- Established safety profile: Demonstrated in prior clinical studies
Contact Information
| Role | Name | Phone | Email |
|------|------|-------|-------|
| Principal Investigator | Paul E Schulz, MD | — | — |
| Study Contact | Harshali Patel | 713-486-0531 | Harshali.Patel@uth.tmc.edu |
| Study Contact | Javier Ortiz, PhD | 713-486-0505 | Guadalupe.J.Ortiz@uth.tmc.edu |
| Study Contact | Christine Farrell, PhD | 713-486-0527 | Christine.M.Farrell@uth.tmc.edu |
Related Pages
- [Alzheimer's Disease Clinical Trials Overview](/clinical-trials/alzheimers-disease)
- [Neuroinflammation Biomarkers](/biomarkers/inflammatory-biomarkers-alzheimers)
- [TSPO PET Imaging for Neuroinflammation](/mechanisms/tspo-pet-imaging-neuroinflammation)
- [Mesenchymal Stem Cell Therapy for Parkinson's Disease](/clinical-trials/nuerownd-stem-cell)
- [GFAP as Biomarker](/biomarkers/gfap-glial-fibrillary-acidic-protein)
- [Neurofilament Light Chain](/biomarkers/neurofilament-light-chain)
- [CSF Biomarkers in Neurodegeneration](/biomarkers/csf-biomarkers-neurodegenerative-disease)
- [Amyloid-β 42/40 Ratio](/biomarkers/amyloid-beta-42-40-ratio)
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