Stem Cell Therapy for Alzheimer's Disease

Overseen By Tim Brown

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stemedica Cell Technologies, Inc.

Disqualifiers: Cancer, Seizure disorder, CADASIL, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using stem cells for individuals with mild to moderate Alzheimer's disease. The goal is to determine the safety of these stem cells and their effectiveness in alleviating symptoms like memory loss and daily functioning. Participants will receive either the stem cells or a placebo (a treatment with no active ingredients) to compare outcomes. This trial suits those who have had Alzheimer's for at least three months and have a positive amyloid PET scan, which detects signs of Alzheimer's in the brain. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

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

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

Research has shown that human mesenchymal stem cells (hMSCs) are generally safe for people. In earlier studies, participants who received a single injection of these cells tolerated it well and did not experience serious side effects. This suggests that hMSCs could be a safe option for those with Alzheimer's disease.

While every treatment carries some risks, current evidence indicates that hMSCs are unlikely to cause major issues. This information may reassure those considering participation in a clinical trial for this treatment. ^{1 2 3 4 5}

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

Researchers are excited about stem cell therapy for Alzheimer's because it offers a fresh approach compared to current treatments like cholinesterase inhibitors and memantine, which mainly manage symptoms. Unlike these medications, stem cells have the potential to actually repair damaged brain tissues by differentiating into neuron-like cells. This therapy aims to tackle the root cause by promoting regeneration and reducing inflammation, providing hope for a more effective treatment strategy.

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

Research has shown that certain stem cells, known as human mesenchymal stem cells (hMSCs), might improve brain health in individuals with Alzheimer's disease. Studies have found that hMSCs can reduce brain inflammation and repair damaged nerve cells, potentially enhancing thinking and memory. Previous research demonstrated that hMSCs support cognitive improvement and enhance the quality of life for those with mild Alzheimer's. Early results are promising, but further research is needed to confirm these effects. Participants in this trial will receive either hMSCs or a placebo to investigate these potential benefits further. ^{1 2 3 6 7}

Who Is on the Research Team?

Lev Verkh, PhD

Principal Investigator

Stemedica Cell Technologies

Are You a Good Fit for This Trial?

This trial is for individuals aged 55-80 with mild to moderate Alzheimer's dementia, confirmed by specific criteria and a positive amyloid PET scan. Candidates must have been diagnosed at least 3 months prior. Those with recent cancer (except certain skin cancers), brain tumors, stem cell treatments, seizures, recent heart attacks, CADASIL syndrome or significant brain hemorrhage history cannot participate.

Inclusion Criteria

I have been diagnosed with Alzheimer's disease for at least 3 months.

Amyloid-positive florbetapir PET scan

My mental state score is between 12 and 24.

Exclusion Criteria

I have had bleeding in my brain.

My brain scan shows more than four tiny bleeds or signs of past significant bleeding.

I have been diagnosed with CADASIL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous dose of hMSCs or placebo on Study Day 1, with a crossover at six months

6 months

Crossover Treatment

Participants receive the alternate treatment (hMSCs or placebo) at the six-month time point

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Human Mesenchymal Stem Cells
• Placebo

Trial Overview The study is testing the safety and potential effectiveness of allogeneic human mesenchymal stem cells (hMSCs) compared to placebo in improving neurological function in Alzheimer's patients. Participants will receive either hMSCs or placebo intravenously and be monitored for changes in their cognitive and psychiatric health.

How Is the Trial Designed?

Group I: Stem Cells Experimental Treatment 1 Intervention

Stem cells

Group II: Placebo Placebo Group 1 Intervention

Lactated Ringer's Solution

Who Is Running the Clinical Trial?

Stemedica Cell Technologies, Inc.

Lead Sponsor

Trials

6

Recruited

170+

Stemedica International SA

Collaborator

Trials

1

Recruited

40+

Citations

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

Mesenchymal Stem Cell Therapy for Alzheimer's Disease - PMC In a study using Tg2576 mice, Cui et al. discovered that human UCB-MSC transplantation significantly mitigated cognitive deterioration of AD ...

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/s41591-025-03559-0

Allogeneic mesenchymal stem cell therapy with ... The study findings support the potential for laromestrocel to improve both cognitive function and QoL in mild AD. Furthermore, detailed brain- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06775964

Stem Cell Therapy for Early Alzheimer's Disease Furthermore, our preclinical and clinical studies with adMSCs have shown that they are safe and effective at reducing inflammation and improving cognitive ...

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

Stem Cell Therapy for Alzheimer's: Findings and Treatment ... Research suggests stem cell therapy may improve brain health by reducing swelling, repairing damaged nerve cells, and improving cognitive function in people ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02513706

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 ...

7. intjem.biomedcentral.com intjem.biomedcentral.com/articles/10.1186/s12245-025-00876-6

Stem cell therapy use in patients with dementia: a systematic ... Studies utilizing SCT demonstrated notable improvements in spatial memory, reduced neuroinflammation, and protection against amyloid-beta (Aβ) toxicity.