10 Participants NeededMy employer runs this trial

Stem Cells + Monoclonal Antibodies for Alzheimer's Disease

ME
Overseen ByMaria E. Puertas
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Bernard (Barry) Baumel
Must be taking: Monoclonal antibodies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining stem cells with standard monoclonal antibody treatments can slow memory and function loss in individuals with mild Alzheimer's Disease. Participants will receive a stem cell infusion alongside their regular Alzheimer's medication. The trial seeks individuals diagnosed with mild Alzheimer's symptoms who are already on approved treatments like Leqembi or Donanemab. Participants should also have a friend or family member to assist in answering questions about daily activities. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial requires that you have been on an FDA-approved monoclonal antibody treatment for at least 6 months before joining. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mesenchymal stem cells (MSCs) are generally safe for people with Alzheimer's disease. A review of 17 clinical trials found that Alzheimer's patients mostly tolerate MSC therapy well, with no major safety concerns. Another study found that MSCs are safe and may help treat brain disorders.

While MSCs appear promising, they remain under study. More research is needed to fully understand their safety and effectiveness. So far, evidence suggests they are a safe option in clinical settings.12345

Why are researchers excited about this trial's treatments for Alzheimer's?

Unlike the standard treatments for Alzheimer's, which primarily focus on managing symptoms with medications like cholinesterase inhibitors and NMDA receptor antagonists, the investigational treatment involving monoclonal antibodies and mesenchymal stem cells offers a novel approach. This treatment is unique because it combines two cutting-edge therapies: monoclonal antibodies, which may target and neutralize harmful proteins in the brain, and mesenchymal stem cells, which have the potential to repair and regenerate damaged brain tissue. Researchers are excited about the possibility that this dual approach could not only slow the progression of Alzheimer's but also potentially restore cognitive function, offering new hope for patients and their families.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

Research has shown that certain stem cells, called mesenchymal stem cells (MSCs), might help treat Alzheimer's Disease (AD). Clinical trials have found that MSC therapy is generally safe and can improve symptoms in people with AD. Animal studies suggest that MSCs can ease Alzheimer's symptoms, boost memory and thinking skills, and reduce harmful brain plaque. One study found that patients receiving MSC treatment showed better results in clinical tests compared to those who received a placebo. Additionally, MSCs might help lower brain inflammation, which plays a significant role in Alzheimer's progression. Overall, early research suggests that MSCs could be a promising way to slow down memory and thinking decline in Alzheimer's patients. Participants in this trial will receive an infusion of human mesenchymal stem cells to further evaluate these potential benefits.12456

Who Is on the Research Team?

BS

Bernard S. Baumel, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 55-90 with mild cognitive impairment or early Alzheimer's disease who have been on an FDA-approved monoclonal antibody (like Leqembi or Kisunla) for at least 6 months. Participants must be able to consent and have a study partner familiar with their daily activities.

Inclusion Criteria

I have mild Alzheimer's and have been on Leqembi or Kisunla for at least 6 months.
* MMSE score 20-26.
* Patients must be able to consent.
See 2 more

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 25 million human mesenchymal stem cells in addition to standard of care monoclonal antibodies

48 weeks
Infusion at baseline, follow-up assessments at Week 16, Week 32, and Week 48

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Human Mesenchymal Stem Cells
  • Monoclonal Antibodies

Trial Overview

The study tests whether adding one infusion of human mesenchymal stem cells to ongoing standard monoclonal antibody treatment can help slow down memory and functional decline in people with early Alzheimer's disease.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mesenchymal Stem Cell InfusionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bernard (Barry) Baumel

Lead Sponsor

Trials
2
Recruited
10+

Citations

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: ...

Mesenchymal stem cell application in Alzheimer's disease

Numerous animal experiments have demonstrated that the efficacy of MSCs in alleviating the symptoms of AD and achieving positive therapeutic outcomes in animal ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41533329/

Therapeutic Efficacy of Mesenchymal Stem Cells (MSCs) ...

The analysis of 17 clinical trials and 5 relevant clinical outcomes showed that MSCs therapy if feasible and generally safe in AD patients.

Mesenchymal stem cell application in Alzheimer's disease

(2) The clinical applications of MSCs. Numerous animal experiments have demonstrated that the efficacy of MSCs in alleviating the symptoms of AD ...

Intravenous Mesenchymal Stem Cells (MSC)

Alzheimer's disease: Intravenously (IV) injected MSCs show some efficacy in multiple mouse models of Alzheimer's disease, in both prophylactic and treatment ...

Safety and Exploratory Efficacy Study of UCMSCs in ...

The primary purpose of this study is to evaluate the safety and the efficacy of (Human Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with ...