Mesenchymal Stem Cells for Alzheimer's Disease

Overseen By Bernard Baumel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bernard (Barry) Baumel

Must be taking: Antipsychotics

Must not be taking: Experimental agents

Disqualifiers: Dementia other than AD, severe depression, substance abuse, bleeding disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding a single infusion of mesenchymal stem cells (hMSC) to regular antipsychotic medication can help manage behavioral problems in individuals with moderate to severe Alzheimer's disease. Researchers aim to determine if this approach can improve symptoms such as delusions, agitation, or anxiety. Individuals diagnosed with Alzheimer's who have experienced behavioral symptoms for at least four weeks while on antipsychotic medication may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early-stage findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you have been on antipsychotic medication for at least 4 weeks before the stem cell infusion.

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

Research has shown that mesenchymal stem cells (hMSCs) are generally safe for people. One study found that a single injection of these cells did not cause any serious side effects. Additionally, studies on Alzheimer's patients have found that these cells can be administered safely, with no major negative reactions. This evidence supports the safety of using hMSCs to treat Alzheimer's disease and suggests they might help with symptoms without causing harm. ^{1 2 3 4 5}

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

Unlike standard treatments for Alzheimer's disease, which typically include medications like cholinesterase inhibitors and memantine that focus on managing symptoms, the investigational treatment hMSC uses mesenchymal stem cells. These stem cells are thought to have the potential to repair and regenerate damaged brain tissue, offering a novel approach that goes beyond symptom management. Researchers are excited about this treatment because it targets the underlying disease process, which could lead to more significant and lasting improvements in cognitive function.

What evidence suggests that this treatment might be an effective treatment for Alzheimer's?

Research suggests that certain stem cells, called mesenchymal stem cells (MSCs), might help with Alzheimer's disease by reducing inflammation and supporting the immune system. One study showed that MSCs can lower inflammation, benefiting brain health. Another study found that MSCs improved conditions more effectively than a placebo. In this trial, participants will receive one infusion of hMSC to evaluate its potential benefits. These cells might also help manage the immune system, potentially leading to better symptom control in Alzheimer's patients. While the results are promising, more research is needed to fully confirm their effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Bernard Baumel, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 55-90 with moderate to severe Alzheimer's, experiencing behavioral issues. They must be on antipsychotic meds for at least 4 weeks and have a caregiver involved. Excluded are those with uncontrolled conditions like hypertension, recent heart attacks, other dementias, substance abuse history, certain infections or cancers within 3 years.

Inclusion Criteria

I am between 55 and 90 years old.

Have a family member or friend (study partner) with frequent and sufficient contact with the patient

Previous brain imaging consistent with AD diagnosis

Exclusion Criteria

I do not have uncontrolled health issues like high blood pressure or recent heart problems.

I have not gone through menopause.

Dementia other than AD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one infusion of hMSC in addition to their current antipsychotic medication

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• hMSC

Trial Overview The study tests if one infusion of human mesenchymal stem cells (hMSC) can improve behavior when added to current antipsychotic treatment in Alzheimer's patients. It aims to see if hMSCs are beneficial alongside standard care.

How Is the Trial Designed?

Group I: hMSC group Experimental Treatment 1 Intervention

Participants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks.

Who Is Running the Clinical Trial?

Bernard (Barry) Baumel

Lead Sponsor

Trials

2

Recruited

10+

Published Research Related to This Trial

A meta-analysis of 152 randomized clinical trials involving 9228 individuals treated with mesenchymal stromal cells (MSCs) found that fever is the only adverse event closely associated with MSC therapy, with a significant odds ratio of 1.61.

The analysis also indicated that MSC therapy may lower the incidence of tachycardia and fatigue, although these findings were not statistically significant, suggesting a generally favorable safety profile for MSC treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient Fever: the Sole Treatment-Related Adverse Event associated with Mesenchymal Stromal Cells and Solid Clues from the Real World. Wang, Y., Mou, Q., Yi, H., et al.[2023]

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. nature.com nature.com/articles/s41392-025-02313-9

Mesenchymal stem cells in treating human diseases The efficacy of adipose MSC treatment was significantly superior to that of the placebo. Long-term efficacy data for the use of Cx601 in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02833792

Allogeneic Human Mesenchymal Stem Cells for ... Study Overview. Primary: To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica ...

5. dvcstem.com dvcstem.com/post/stem-cell-therapy-for-alzheimers

Stem Cell Therapy for Alzheimer's: Findings and Treatment ... Mesenchymal stem cells (MSCs), in particular, have been found to both support the immune system and reduce inflammation. According to a 2020 study, MSCs may ...

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

Mesenchymal Stem Cell Therapy for Alzheimer's Disease - PMC ... cells/60 μL). Results showed that a single injection of human UCB-MSCs was safe and well tolerated and did not cause serious adverse effects ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06781333

Human Mesenchymal Stem Cells (hMSC) in Behavioral ... The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help ...

8. nature.com nature.com/articles/s41591-025-03559-0

Allogeneic mesenchymal stem cell therapy with ... Laromestrocel improved clinical assessments at 39 weeks compared to placebo, as measured by a composite AD score (secondary end point was met: ...

9. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1440334/full

Stem cell therapy in Alzheimer's disease: current status ... These results demonstrated that stereotactic injection of hUCB-MSCs into the hippocampus and precuneus is safe, feasible, and well tolerated (Kim et al., 2015).