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

Trial Summary

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.

What data supports the effectiveness of the treatment hMSC for Alzheimer's disease?

Research shows that mesenchymal stem cells (a type of cell that can develop into different types of cells) have improved memory and neurological function in animal models of Alzheimer's disease. These studies suggest that this treatment might help with Alzheimer's by improving brain function and reducing inflammation. ^{1 2 3 4 5}

Is the treatment with mesenchymal stem cells generally safe for humans?

In a small study with Alzheimer's patients, the main side effect of mesenchymal stem cell treatment was a temporary fever. Other studies in animals did not show any serious safety concerns, like cancerous changes, suggesting the treatment is generally safe. ^{1 4 5 6 7}

How is the mesenchymal stem cell treatment for Alzheimer's disease different from other treatments?

This treatment uses mesenchymal stem cells, which are special cells that can develop into different types of cells and help repair damaged tissues. Unlike traditional Alzheimer's treatments that mainly focus on symptoms, this approach aims to improve brain function and memory by promoting brain repair and reducing harmful proteins. It can be administered directly into the brain or through the bloodstream, offering flexibility in treatment delivery. ^{1 3 4 5 8}

What is the purpose of this trial?

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 control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.

Research Team

Bernard Baumel, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic effect of mesenchymal multipotent stromal cells on memory in animals with Alzheimer-type neurodegeneration. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effect of systemic transplantation of bone marrow-derived mesenchymal stem cells on neuropathology markers in APP/PS1 Alzheimer mice. [2018]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

A Mesenchymal Stem Cell Line Transplantation Improves Neurological Function and Angiogenesis in Intraventricular Amyloid β-Infused Rats. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Therapeutic effect of mesenchymal stem cells in an animal model of Alzheimer's disease evaluated by β-amyloid positron emission tomography imaging. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

In vivo tracking of intravenously injected mesenchymal stem cells in an Alzheimer's animal model. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trial. [2022]

7. United Arab Emirates 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. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[The combined effects of beta-sheet breaker and hUCMSC on APP transgenic mice]. [2018]