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Stem Cell Therapy

Stem Cell Therapy for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by Stemedica Cell Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment based on NINDS-ADRDA Alzheimer's criteria
MMSE between 12-24 at time of enrollment
Must not have
History of intracranial, subdural, or subarachnoid hemorrhage
Subjects with baseline brain MRI showing more than four cerebral microhemorrhages or one or more areas of superficial siderosis or evidence of a prior macrohemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months

Summary

This trial will test the safety and tolerability of hMSCs in people with Alzheimer's-related dementia. It will also assess the preliminary efficacy of hMSCs in people with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the main goal is to assess safety, possible side effects may include reactions at the infusion site, allergic responses, fever or chills. Since this treatment involves stem cells administered intravenously, there might also be risks related to immune system reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alzheimer's disease for at least 3 months.
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My mental state score is between 12 and 24.
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I am between 55 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had bleeding in my brain.
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My brain scan shows more than four tiny bleeds or signs of past significant bleeding.
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I have been diagnosed with CADASIL.
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I have had a brain tumor.
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I have previously undergone stem cell treatment.
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I have a history of seizures.
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I haven't had cancer in the last 5 years, except for skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of aMBMC administration
Secondary study objectives
Efficacy of aMBMC administration

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stem CellsExperimental Treatment1 Intervention
Stem cells
Group II: PlaceboPlacebo Group1 Intervention
Lactated Ringer's Solution

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Who is running the clinical trial?

Stemedica Cell Technologies, Inc.Lead Sponsor
5 Previous Clinical Trials
130 Total Patients Enrolled
Stemedica International SAUNKNOWN
Lev Verkh, PhDStudy ChairStemedica Cell Technologies
2 Previous Clinical Trials
67 Total Patients Enrolled

Media Library

Human Mesenchymal Stem Cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02833792 — Phase 2
Human Mesenchymal Stem Cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02833792 — Phase 2
Alzheimer's Dementia Research Study Groups: Stem Cells, Placebo
Alzheimer's Dementia Clinical Trial 2023: Human Mesenchymal Stem Cells Highlights & Side Effects. Trial Name: NCT02833792 — Phase 2
~4 spots leftby Nov 2025
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