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Allogeneic Mesenchymal Stem Cell Therapy

Allogeneic MSC for Alzheimer's Disease (CLEARMIND Trial)

Phase 2
Waitlist Available
Research Sponsored by Longeveron Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 41 weeks
Awards & highlights

CLEARMIND Trial Summary

This trial is testing a new treatment for Alzheimer's disease, which if effective, could improve cognitive function and reduce inflammation.

Eligible Conditions
  • Mild Alzheimer's Disease

CLEARMIND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~41 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 41 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint 1: Safety - SAEs and AEs
Primary Endpoint 2: Safety - Imaging
Secondary outcome measures
Secondary Endpoint 2: Efficacy- Change in the ADAS-cog-13
Secondary Endpoint 3: Efficacy- Change in the MMSE

CLEARMIND Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Lomecel-B Dose 3Experimental Treatment1 Intervention
Group 4 will receive four infusions of Lomecel-B at a dose of 100 x 10^6 cells (100M) on Day 0, Week 4, Week 8, and Week 12.
Group II: Lomecel-B Dose 2Experimental Treatment1 Intervention
Group 3 will receive four infusions of 25M Lomecel-B on Day 0, Week 4, Week 8, and Week 12.
Group III: Lomecel-B Dose 1Experimental Treatment1 Intervention
Group 2 will receive an infusion of Lomecel-B at a dose of 25 x 10^6 cells (25M) on Day 0, followed by Placebo infusions at Week 4, Week 8, and Week 12.
Group IV: PlaceboPlacebo Group1 Intervention
Group 1 will receive four infusions of Placebo on Day 0, Week 4, Week 8, and Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic MSC
2021
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Longeveron Inc.Lead Sponsor
9 Previous Clinical Trials
433 Total Patients Enrolled
bioRASI, LLCIndustry Sponsor
13 Previous Clinical Trials
3,606 Total Patients Enrolled

Media Library

Lomecel-B (Allogeneic Mesenchymal Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05233774 — Phase 2
Alzheimer's Disease Research Study Groups: Placebo, Lomecel-B Dose 1, Lomecel-B Dose 2, Lomecel-B Dose 3
Alzheimer's Disease Clinical Trial 2023: Lomecel-B Highlights & Side Effects. Trial Name: NCT05233774 — Phase 2
Lomecel-B (Allogeneic Mesenchymal Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233774 — Phase 2

Frequently Asked Questions

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

Are there any remaining opportunities for individuals to join this research trial?

"According to clinicaltrials.gov, this research endeavour is actively searching for participants. It was initially uploaded on December 28th 2021 and updated most recently on August 15th 2022."

Answered by AI

What is the upper limit of individuals involved in this research project?

"Correct. Clinicaltrials.gov data indicates that this clinical study is still recruiting subjects, with the first posting having been on December 28th 2021 and most recent update occurring August 15th 2022. This medical trial requires 48 participants to be admitted at 13 separate sites."

Answered by AI

Could I be a potential candidate for this experiment?

"This clinical trial is seeking a cohort of 48 individuals, aged between 60 and 85 with clinically diagnosed mild Alzheimer's disease. Participants must also meet various other stipulations such as having an MMSE score in the range of 19-23, bodyweight within 40-150 kgs, and have access to an adult caretaker who consents to accompany them during all study visits."

Answered by AI

Has the FDA authorized Allogeneic MSC to be used in medical treatments?

"Our team of analysts at Power rated the safety of Allogeneic MSC as a 2. This is because, although there is data validating its security, no evidence supports its efficacy yet since it only reached Phase 2 in trials."

Answered by AI

Does this particular research permit individuals of advanced age to participate?

"This trial has specified that participants must be between 60 and 85 years old. There are 23 studies for patients under the legal age of consent, while 536 are available to those over 65 years old."

Answered by AI

What is the geographic distribution of this trial's implementation?

"Presently, the locations for this clinical trial span 13 different sites across America. In particular, there are available spots in Miami, Delray Beach and Doral as well as 10 other urban centres. To minimize travel commitments, it is recommended that potential participants select a nearby location if able to do so."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Lomecel-B Effects on Alzheimer's Disease
2021. "Lomecel-B Effects on Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233774.
~15 spots leftby Apr 2025
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