Evidence map›Paper›PMID 35357079›Full record

Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2023

Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease.

Mark Brody, Marc Agronin, Brad J Herskowitz, Susan Y Bookheimer, Gary W Small, Benjamin Hitchinson, Kevin Ramdas, Tyler Wishard, Katalina Fernández McInerney, Bruno Vellas and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07512362 (A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells), which is not on this map. Cited by 49 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07512362 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild Alzheimer's Disease.

TypeinterventionalSponsorBernard (Barry) BaumelRan2026 to 2028Enrolled10ConditionsMild Cognitive Impairment, Early Alzheimer's Disease, AD-MCIArmshuman Mesenchymal Stem Cells
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2023
    Trial
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Boosting Neurogenesis as a Strategy in Treating Alzheimer's Disease.International journal of molecular sciences · 2025
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Mark BrodyBrain Matters Research, Delray Beach, Florida, USA.
Marc AgroninMiami Jewish Health, Miami, Florida, USA.
Brad J HerskowitzThe Neurology Group, Kendall, Florida, USA.
Susan Y BookheimerDept. of Psychiatry and Biobehavioral Sciences, and Semel Institute For Neuroscience and Human Behavior, UCLA David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Gary W SmallPsychiatry, Hackensack Meridian Health, Hackensack University Medical Center, Hackensack, New Jersey, USA.
Benjamin HitchinsonLongeveron Inc., Miami, Florida, USA.
Kevin RamdasLongeveron Inc., Miami, Florida, USA.
Tyler WishardInterdepartmental Program in Neuroscience, UCLA, and Semel Institute For Neuroscience and Human Behavior, UCLA David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Katalina Fernández McInerneyDepartment of Neurology, University of Miami Miller School of Medicine, Miami, Florida, USA.
Bruno VellasGérontopôle, Department of Geriatric Internal Medicine, University of Toulouse, Toulouse, France.
Felipe SierraNational Institute of Aging, National Institutes of Health, Bethesda, Maryland, USA.
Zhijie JiangM2Gen, Tampa, Florida, USA.
Lisa Mcclain-MossLongeveron Inc., Miami, Florida, USA.
Carmen PerezDepartment of Neurology, University of Miami Miller School of Medicine, Miami, Florida, USA.
Ana FuquayBrain Matters Research, Delray Beach, Florida, USA.
Savannah RodriguezThe Neurology Group, Kendall, Florida, USA.
Joshua M HareLongeveron Inc., Miami, Florida, USA.ORCID 0000-0002-7751-5032
Anthony A OlivaLongeveron Inc., Miami, Florida, USA.ORCID 0000-0002-3099-2421
Bernard BaumelDepartment of Neurology, University of Miami Miller School of Medicine, Miami, Florida, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

hypothesisWe hypothesized that Lomecel-B, an allogeneic medicinal signaling cell (MSC) therapeutic candidate for Alzheimer's disease (AD), is safe and potentially disease-modifying via pleiotropic mechanisms of action. KEY PREDICTIONS: We prospectively tested the predictions that Lomecel-B administration to mild AD patients is safe (primary endpoint) and would provide multiple exploratory indications of potential efficacy in clinical and biomarker domains (prespecified secondary/exploratory endpoints). STRATEGY AND KEY

resultsMild AD patient received a single infusion of low- or high-dose Lomecel-B, or placebo, in a double-blind, randomized, phase I trial. The primary safety endpoint was met. Fluid-based and imaging biomarkers indicated significant improvement in the Lomecel-B arms versus placebo. The low-dose Lomecel-B arm showed significant improvements versus placebo on neurocognitive and other assessments.

interpretationOur results support the safety of Lomecel-B for AD, suggest clinical potential, and provide mechanistic insights. This early-stage study provides important exploratory information for larger efficacy-powered clinical trials.

Indexed as

Alzheimer DiseaseBiomarkersDouble-Blind MethodHumansTreatment OutcomeBiomarkersAlzheimer diseaseanti-inflammatory agentsbiological therapybone marrow mesenchymal stem cellclinical trialcytokineshippocampushuman bone marrowinflammationinflammation mediatorsinterleukinsLomecel-Bmedicinal signaling cellmesenchymal stem cellmesenchymal stromal cellmultipotent stem cellsneuroimagingneuroinflammatory diseasesrandomized controlled trialregenerative medicinevascularvascular endothelial cell growth factor

Identifiers

PMID35357079
PMCPMC10084163

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.