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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

STUDY OBJECTIVES Primary: To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects with mild to moderate dementia due to Alzheimer's disease. Secondary: To assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.

Research Team

Lev Verkh, PhD

Principal Investigator

Stemedica Cell Technologies

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+