Cognitive DysfunctionPhase 1/2NCT06775964
Stem Cell Therapy for Early Alzheimer's Disease
A Phase 1/2 study testing adMSC in people with Cognitive Dysfunction, run by Paul E Schulz at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- adMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Has an MRI to evaluate AD pathology (may use previous if within 6mo.)
- Has APOE status to evaluate AD pathology (may use previous result)
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- Proficiency in English is required because cognitive tests are administered in English only.
- Has evidence of brain amyloidosis via PET Scan or Aβ42/40 ratios in CSF.
- 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.
- Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.
Who cannot join
- 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.
- Females of childbearing potential must not be pregnant.
- Inability or unwillingness to undergo PET Scans.
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- Inability or unwillingness to undergo MRI Scans.
- Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis
- Positive for TSPO SNP rs6971
- Inability or unwillingness to undergo Lumbar Punctures.
- Inability or unwillingness to undergo infusions.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston (UTHealth)
Houston, Texas, 77054
Javier Ortiz, PhD, 713-486-0505, Guadalupe.J.Ortiz@uth.tmc.edu
Christine Farrell, PhD, 713-486-0527, Christine.M.Farrell@uth.tmc.edu
About this study
Official title: Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease
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?
Read more
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
Read the detailed description
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.
To date, most drugs for AD primarily treat symptoms. Moreover, several anti-amyloid antibodies have reduced amyloid burden, but have only modestly affected cognitive progression, suggesting that other pathways are also important for AD progression. Neuroinflammation may be important for AD progression. The discovery of increased levels of inflammatory markers in patients at different clinical stages of AD, and the iden-tification of AD risk genes associated with innate immune functions, suggest that neuroinflammation may affect AD pathogenesis, making it an optimal candidate for targeted therapy to reduce disease progression. In this study, we aim to treat neuroinflammation with autologous adMSCs. These cells may represent a superior therapeutic alternative for AD be-cause they exhibit multi-therapeutic effects, including anti-inflammatory properties, reduced amyloid-β activity, and neurogenesis, which collec-tively, may reduce disease progression and improve brain activity. In addition, autologous adMSCs demonstrate low immunogenicity, which limits Graft Versus Host Disease (GVHD) during cell administration. Furthermore, our preclinical and clinical studies with adMSCs have shown that they are safe and effective at reducing inflammation and improving cognitive outcomes. A positive outcome would result in a paradigm shift in the treatment of AD that could potentially be a standard of care.
- Conditions
- Cognitive Dysfunction
- Being tested
- adMSC
- Keywords
- Mild Cognitive Impairment, Cognitive Decline, Alzheimer's disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adMSCBiological
IV-infusion of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs), of approximately 2x10(8) adMSCs in 250mL saline.
| Study group | Role | What they receive |
|---|---|---|
| adMSC | Experimental | IV-infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs) Receives: Biological: adMSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, midpoint (169 days from 1st infusion)
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.
Measured: Baseline, midpoint (169 days from 1st infusion)
Secondary outcomes (11)
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
Measured: Baseline - End of Study (337 days from 1st infusion)
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.
Measured: Baseline, midpoint (169 days from 1st infusion)
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.
Measured: Baseline, midpoint (169 days from 1st infusion)
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.
Measured: Baseline, midpoint (169 days from 1st infusion)
Changes in cerebral metabolism activity via FDG PET imaging from image baseline to midpoint
Levels of [18F]FDG radiotracer will be measured for each PET scan. The uptake of [18F]FDG by the brain is a marker for cerebral metabolism activity
Measured: Baseline, midpoint (169 days from 1st infusion)
Changes in amyloid-β 42/40 ratio in CSF following adMSC therapy
Levels of amyloid-β 42/40 ratio in CSF will be measured by LC/MS/MS assays. Aggregate values and percentages will be reported
Measured: Baseline, midpoint (169 days from 1st infusion)
Change in Mini-Mental Status Examination (MMSE) following adMSC therapy
Cognition measured by MMSE. Scoring: 24-30 no cognitive impairment; 18-23 mild cognitive impairment; 0-17 severe cognitive impairment.
Measured: Baseline, End of Study (337 days from 1st infusion)
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores following adMSC therapy
Cognitive decline measured by RBANS. Total Score subtest ranges: List Learning (0-40); Story Memory (0-24); Figure Copy (0-20); Line Orientation (0-20); Picture Naming (0-10); Semantic Fluency (4-40); Digit Span (0-16); Coding (0-89); List Recall (0-10); List Recognition (0-20); Story Recall (0-12); Figure Recall (0-20). Use Stimulus Booklet to convert Total Scores to Index Scores and Sum of Index Scores to Total Scale. Total Scores can range from 40 to 160. The RBANS scores are displayed as standard scores with means of 100 and a standard deviation of 15. Average/Mild Impairment (standard scores of 70 or above), Moderate Impairment (standard scores from 55 to 69), and Severe Impairment (standard scores <54).
Measured: Baseline, End of Study (337 days from 1st infusion)
Change in instrumental activities of daily living via Lawton IADL Scale scores following adMSC therapy
The Lawton IADL scale contains eight items. Each ability measured by the scale relies on either cognitive or physical function, though all require some degree of both. The higher the score, the greater the person's abilities. Women are scored on all 8 areas of function, but, for men, the areas of food preparation, housekeeping, laundering are excluded. Clients are scored according to their highest level of functioning in that category. The final total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. The final total score may be presented as a percentage of function. For example, a total score of 6 out of 8 would represent 75% function (75% independence, 25% dependence). Sequential scoring over time provides a measure of declining or
Measured: Baseline, End of Study (337 days from 1st infusion)
Measure immune pathway marker level changes in blood from screening/baseline to midpoint (D1-D169) and from screening/baseline to end of study (D1-D337)
A commercially available immunological panel that tests markers associated with immunological pathways will be performed in blood at the end of study. Aggregate values and percentages will be reported.
Measured: Baseline, midpoint (169 days from 1st infusion), End of Study (337 days from 1st infusion)
Measure immune pathway marker level changes from screening/baseline to midpoint (D1-D169) in CSF
A commercially available immunological panel that tests markers associated with immunological pathways will be performed in CSF at the end of study. Aggregate values and percentages will be reported.
Measured: Baseline, midpoint (169 days from 1st infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start11 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul E Schulz
- Sponsor type
- University, hospital or other
- Collaborators
- Weston Brain Institute
- Responsible party
- Sponsor-investigator, Paul E Schulz, The University of Texas Health Science Center, Houston
- Investigators
- Paul E Schulz, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775964
- Sponsor's protocol ID
- HSC-MS-24-0516
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06775964
- Acronym / sponsor ID
- HSC-MS-24-0516
- Conditions
- Cognitive Dysfunction
- Keywords
- Mild Cognitive Impairment, Cognitive Decline, Alzheimer's disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Paul E SchulzUniversity, hospital or other
- Collaborators
- Weston Brain Institute
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
To date, most drugs for AD primarily treat symptoms. Moreover, several anti-amyloid antibodies have reduced amyloid burden, but have only modestly affected cognitive progression, suggesting that other pathways are also important for AD progression. Neuroinflammation may be important for AD progression. The discovery of increased levels of inflammatory markers in patients at different clinical stages of AD, and the iden-tification of AD risk genes associated with innate immune functions, suggest that neuroinflammation may affect AD pathogenesis, making it an optimal candidate for targeted therapy to reduce disease progression. In this study, we aim to treat neuroinflammation with autologous adMSCs. These cells may represent a superior therapeutic alternative for AD be-cause they exhibit multi-therapeutic effects, including anti-inflammatory properties, reduced amyloid-β activity, and neurogenesis, which collec-tively, may reduce disease progression and improve brain activity. In addition, autologous adMSCs demonstrate low immunogenicity, which limits Graft Versus Host Disease (GVHD) during cell administration. Furthermore, our preclinical and clinical studies with adMSCs have shown that they are safe and effective at reducing inflammation and improving cognitive outcomes. A positive outcome would result in a paradigm shift in the treatment of AD that could potentially be a standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| adMSC | Experimental | Biological: adMSCIV-infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Has an MRI to evaluate AD pathology (may use previous if within 6mo.)
Key exclusion criteria (12 listed)
- 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.
- Females of childbearing potential must not be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adMSCIV-infusion of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs), of approximately 2x10(8) adMSCs in 250mL saline. | Biological | adMSC |
Primary outcome
Change in TSPO levels, measured by the PET scan, from baseline to midpoint and baseline to end of study
Time frame: Baseline, midpoint (169 days from 1st infusion)
Level of TSPO PET tracer will be measured for each PET scan. TSPO positivity, which is a marker for activated microglia, correlates with neuroinflammation
Inflammatory cytokines in CSF following adMSC therapy
Time frame: Baseline, midpoint (169 days from 1st infusion)
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.
11 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: Baseline - End of Study (337 days from 1st infusion)
Changes in neurofilament light chain (Nf-L) in CSF following adMSC therapy
Time frame: Baseline, midpoint (169 days from 1st infusion)
Changes in Glial fibrillary acidic protein (GFAP) in CSF following adMSC therapy
Time frame: Baseline, midpoint (169 days from 1st infusion)
Changes in Total Tau/phosphor-Tau ratios in CSF following adMSC therapy
Time frame: Baseline, midpoint (169 days from 1st infusion)
Changes in cerebral metabolism activity via FDG PET imaging from image baseline to midpoint
Time frame: Baseline, midpoint (169 days from 1st infusion)
Changes in amyloid-β 42/40 ratio in CSF following adMSC therapy
Time frame: Baseline, midpoint (169 days from 1st infusion)
Change in Mini-Mental Status Examination (MMSE) following adMSC therapy
Time frame: Baseline, End of Study (337 days from 1st infusion)
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores following adMSC therapy
Time frame: Baseline, End of Study (337 days from 1st infusion)
Change in instrumental activities of daily living via Lawton IADL Scale scores following adMSC therapy
Time frame: Baseline, End of Study (337 days from 1st infusion)
Measure immune pathway marker level changes in blood from screening/baseline to midpoint (D1-D169) and from screening/baseline to end of study (D1-D337)
Time frame: Baseline, midpoint (169 days from 1st infusion), End of Study (337 days from 1st infusion)
Measure immune pathway marker level changes from screening/baseline to midpoint (D1-D169) in CSF
Time frame: Baseline, midpoint (169 days from 1st infusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul E Schulz, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adMSC in people with Cognitive Dysfunction, run by Paul E Schulz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harshali Patel (713-486-0531, Harshali.Patel@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TSPO levels, measured by the PET scan, from baseline to midpoint and baseline to end of study (time frame: Baseline, midpoint (169 days from 1st infusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.