Evidence map›Paper›PMID 41747733›Full record

Trial reportCell stem cell2026

Randomized phase 2b dose-escalation trial of stem cell therapy with laromestrocel for aging frailty.

Jorge G Ruiz, Anthony A Oliva, Kevin N Ramdas, Julian Javier, Jeffrey Rosen, Robert Perry, Antonio Blanco, Pedro Ylisastigui, Jeremy Walston, Hidenori Arai and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Cell stem cell, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03169231 (A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Longeveron Allogenic Human Mesenchymal Stem Cells Infusion in Patients With Aging Frailty), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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.

NCT03169231 phase2completednot on this map

A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Longeveron Allogenic Human Mesenchymal Stem Cells Infusion in Patients With Aging Frailty

TypeinterventionalSponsorLongeveron Inc.Ran2017 to 2021Enrolled150ConditionsAging FrailtyArmsLongeveron Mesenchymal Stem Cells (LMSCs), Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. How human and animal frailty index studies can inform each other: a brief narrative review.The journals of gerontology. Series A, Biological sciences and medical sciences · 2026
    Review
  5. Frailty in Parkinson's disease: time to integrate it into treatment decision-making?Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
  6. Review
  7. Review
  8. Article
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

25 authors.

Jorge G RuizMemorial Healthcare System, Hollywood, FL, USA; Florida Atlantic University Schmidt College of Medicine, Boca Raton, FL, USA.
Anthony A OlivaLongeveron Inc., Miami, FL, USA.
Kevin N RamdasLongeveron Inc., Miami, FL, USA.
Julian JavierAdvanced Research for Health Improvement, LLC, Naples, FL, USA.
Jeffrey RosenClinical Research of South Florida, Coral Gables, FL, USA.
Robert PerryPanax Clinical Research, Miami Lakes, FL, USA.
Antonio BlancoVista Health Research, LLC, Miami, FL, USA.
Pedro YlisastiguiClinical Physiology Associates, Ft. Myers, FL, USA.
Jeremy WalstonJohns Hopkins University, Baltimore, MD, USA.
Hidenori AraiNational Center for Geriatrics and Gerontology, Obu, Japan.
Elena VolpiSealy Center on Aging, University of Texas Medical Branch, Galveston, TX, USA.
Anne B NewmanDepartment of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
Brittany VarnadoLongeveron Inc., Miami, FL, USA.
Lisa McClain-MossLongeveron Inc., Miami, FL, USA.
Eric NaiotiLongeveron Inc., Miami, FL, USA.
Danial MehranfardLongeveron Inc., Miami, FL, USA.
Dan GincelLongeveron Inc., Miami, FL, USA.
Chao WangPharma Data Associates LLC, Piscataway, NJ, USA.
Michael J MintzerMiami VA Healthcare System Geriatric Research, Education and Clinical Center (GRECC), Miami, FL 33125, USA.
Joel DanisiMiami VA Healthcare System Geriatric Research, Education and Clinical Center (GRECC), Miami, FL 33125, USA.
Geoff A GreenLongeveron Inc., Miami, FL, USA.
Jeffrey BotbylProvonix, Sewell, NJ 08080, USA.
Zarin ZainulLongeveron Inc., Miami, FL, USA.
Brian G RashLongeveron Inc., Miami, FL, USA.
Joshua M HareLongeveron Inc., Miami, FL, USA; Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: jhare@longeveron.com.

Funding

San Antonio OAIC - Research Education Component (REC)P30AG044271 · NIA · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Adam Salmon, Elena Volpi · 2015 to 2026
$14.1M
A Phase 2b Clinical Trial to Study the Efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) to Treat Aging FrailtyR44AG062015 · NIA · LONGEVERON, LLC · PI HARE, JOSHUA M, OLIVA, ANTHONY ANDREW · 2018 to 2020
$4.2M
A Randomized, Blinded, Placebo-Controlled Clinical Trial to Evaluate Longeveron Mesenchymal Stem Cell (LMSC) Therapy for Treating The Metabolic SyndromeR42AG054322 · NIA · LONGEVERON, LLC · PI HARE, JOSHUA M, LENG, SEAN XIAO · 2017 to 2020
$1.1M
NIA NIH HHS P30 AG044271NIA NIH HHS R42 AG054322NIA NIH HHS R44 AG062015
6 · The paper itself

Abstract

Frailty, a syndrome that decreases healthspan in older individuals, lacks effective therapies. We conducted a randomized, dose-finding clinical trial to test whether human bone marrow-derived allogeneic mesenchymal stem cells (MSCs; laromestrocel) improve physical functioning and patient self-reported outcomes in ambulatory individuals with frailty (ClinicalTrials.gov #NCT03169231; N = 148). Laromestrocel infusion results in clinically meaningful, dose- and time-dependent increases in the 6-min walk test (6MWT; primary endpoint) compared with placebo: 63.4 m (95% confidence interval [CI]: 17.1-109.6 m; p = 0.0077) at month 9 and 41.3 m (95% CI: -2.4-84.9 m; p = 0.0635) at month 6. Increased 6MWT distance correlates with PROMIS Physical Function score, and increasing doses of laromestrocel are associated with decreases in soluble (degraded) tyrosine kinase with immunoglobulin and epidermal growth factor homology domains (TIE2), the cognate receptor for the angiopoietins, identifying a potential biomarker of laromestrocel responsiveness. These findings identify a stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty.

Indexed as

AgingFrailtyMesenchymal Stem CellsMesenchymal Stem Cell TransplantationAgedFemaleHumansMaleagingaging frailtycell therapyhealthspaninflammaginglaromestrocellongevitymesenchymal stem cellTIE2

Identifiers

PMID41747733
PMCPMC13035327

What OpenQuestion holds

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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.