Stem Cell Therapy for Alzheimer's Disease

Overseen By Harshali Patel

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Paul E Schulz

Disqualifiers: TBI, Parkinson's, Multiple sclerosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether stem cell therapy (adMSC) can alleviate brain inflammation associated with memory and thinking problems. By using stem cells from a person's own fat, the researchers aim to determine if this treatment can reduce inflammation, enhance brain activity, and slow the progression to Alzheimer's disease. The trial includes stem cell infusions and regular checkups over several months. Suitable participants have mild memory issues related to Alzheimer's and show signs of brain inflammation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Studies have shown that using stem cells from fat tissue for Alzheimer's is generally safe. In one study, researchers reported 84 side effects, spread across different doses, with most being mild and not a major concern.

Another study examined the safety of these stem cells in a small group of Alzheimer's patients. The results suggested that the treatment did not cause any serious side effects. While some minor effects may occur, serious problems seem unlikely based on current research.

Overall, the studies suggest that these stem cells are safe for use in humans, with most side effects being mild and manageable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike standard Alzheimer's treatments, which primarily focus on managing symptoms and slowing disease progression, adMSC therapy uses a novel approach by employing autologous, adipose-derived Mesenchymal Stem Cells (adMSCs). These stem cells are administered via IV infusions and have the potential to repair and regenerate damaged brain tissue, offering a new hope for modifying the disease rather than just controlling it. Researchers are excited about this treatment because it targets the underlying mechanisms of Alzheimer's, which could lead to more effective and long-lasting results compared to current therapies.

What evidence suggests that stem cell therapy might be an effective treatment for Alzheimer's?

Research has shown that stem cell therapy, particularly using stem cells from fat tissue, holds promise for treating Alzheimer's disease. In this trial, participants will receive IV infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs). Studies have found that these stem cells can reduce brain inflammation, often linked to memory and thinking problems in Alzheimer's patients. Additionally, these stem cells have demonstrated the ability to reduce inflammation and help regulate the immune system. Early findings from various studies suggest improvements in brain activity and a possible slowing of the disease's progression. While more research is needed, these initial results offer encouragement for those affected by Alzheimer's. ^{2 3 4 5 6}

Who Is on the Research Team?

Paul E Schulz, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults with memory or thinking problems due to conditions like early Alzheimer's or mild cognitive impairment. Participants must be willing to have a small fat biopsy and receive stem cell infusions. Specific eligibility details are not provided, but typically there would be criteria related to age, disease severity, and overall health.

Inclusion Criteria

Has signed an informed consent form before any assessment is performed as part of the study

Has an MRI to evaluate AD pathology (may use previous if within 6mo.)

I am between 60 and 80 years old.

Exclusion Criteria

I have a condition like TBI, PD, or MS that could affect my thinking.

I have the TSPO SNP rs6971 mutation.

My condition is stable and does not include severe heart, kidney, liver issues, or autoimmune diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 4 infusions of autologous, adipose-derived Mesenchymal Stem Cells over 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants 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

8 months

Multiple visits (in-person)

Long-term follow-up

Participants are monitored for safety and effectiveness after treatment

337 days from 1st infusion

What Are the Treatments Tested in This Trial?

Interventions

• adMSC

Trial Overview The study tests whether stem cells derived from participants' own fat can reduce brain inflammation and improve cognitive function in those showing early signs of Alzheimer's. It involves processing these cells and administering them back into the patient through arm vein infusions over 12 weeks.

How Is the Trial Designed?

Group I: adMSC Experimental Treatment 1 Intervention

IV-infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs)

Who Is Running the Clinical Trial?

Paul E Schulz

Lead Sponsor

Trials

2

Recruited

30+

Weston Brain Institute

Collaborator

Trials

13

Recruited

990+

Published Research Related to This Trial

Intrathecal injection of bone marrow stromal cells (BMSCs) in a rat model of Alzheimer's disease led to the successful migration and differentiation of these cells into cholinergic neurons, which are crucial for cognitive function.

The treatment resulted in an increase in healthy neurons and a decrease in damaged neurons, suggesting that BMSC therapy could be a promising approach for Alzheimer's disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of intrathecal delivery of bone marrow stromal cells on hippocampal neurons in rat model of Alzheimer's disease. Eftekharzadeh, M., Nobakht, M., Alizadeh, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9584646/

Mesenchymal stromal cells for the treatment of Alzheimer's ... This review focuses on different clinical and preclinical studies using MSC as a therapy for treating AD, their outcomes, limitations and the strategies to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352320425001609

Mesenchymal stem cell application in Alzheimer's disease The evidence demonstrated that the subject has the anti-inflammatory and immune regulatory effects and it has the capacity to differentiate into osteocytes [19] ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04855955?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(stem%20cells%20AND%20alzheimer's))&rank=9

Autologous Human Adipose-Derived Mesenchymal Stem ... This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease ...

4. brieflands.com brieflands.com/journals/jssc/articles/109466

Efficacy of Adipose-Derived Stem Cells as a Potential ... This systematic review was performed to review the outcomes of treatment with adipose-derived stem cells in Alzheimer's disease starting from in-vitro, in-vivo, ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1655124/full

Adipose-derived mesenchymal stem cells for the treatment ... A total of 84 AEs were reported during this period: 33 (39.29%) in the lower dose of AdMSC group, 27 (32.14%) in the second dose group and 24 (28.57%) in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8426054/

Mesenchymal Stem Cell Therapy for Alzheimer's Disease - PMC Results showed that RVG-conjugated mesenchymal stem cell-derived exosomes (MSC-RVG-Exo) improved memory deficits, decreased plaque deposition ...