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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of aMBMC administration

Secondary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the relevant medical condition able to sign up for this trial at this time?

"The listing on clinicaltrials.gov does show that this research is looking for volunteers at the moment. This trial was first advertised on 6/1/2016 and has been edited most recently on 10/27/2022. The study requires 40 individuals from 1 location."

Answered by AI

Can minors participate in this research?

"This specific trial is only open to patients aged 55-80. Out of the 35 trials for people under 18 and 771 for those over 65, this is one of the few that offers medication specifically to this age group."

Answered by AI

Could you please summarize the risks associated with Human Mesenchymal Stem Cells and Lactated Riunger's Solution?

"This is a Phase 2 trial, so while there is some evidence that the Human Mesenchymal Stem Cells and Lactated Riunger's Solution are safe, nothing has been proven in terms of efficacy. We gave it a score of 2."

Answered by AI

How many test subjects are needed for this research?

"That is correct. The listing on clinicaltrials.gov currently says that the trial is recruiting patients. This particular study was originally posted on 6/1/2016, and has since been updated on 10/27/2022. At the moment, the goal is to enroll 40 participants from 1 location."

Answered by AI

Could I qualify to take part in this experiment?

"This study is looking for 40 individuals that suffer from Alzheimer's disease and meet the age criteria of being between 55-80 years old. Furthermore, it is essential that patients fulfil the following: be either male or female, have had a mild to moderate dementia diagnosis for at least 3 months before enrolling in this trial, use the National Institute of Neurological and Communicative Diseases (NINCD), and finally have a MMSE score between 12-24."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

2016. "Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02833792.

All > Alzheimers Disease Anaheim