Evidence map›Paper›PMID 28977399›Full record

Trial reportThe journals of gerontology. Series A, Biological sciences and medical sciences2017

Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Bryon A Tompkins, Darcy L DiFede, Aisha Khan, Ana Marie Landin, Ivonne Hernandez Schulman, Marietsy V Pujol, Alan W Heldman, Roberto Miki, Pascal J Goldschmidt-Clermont, Bradley J Goldstein and 20 more

5 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The journals of gerontology. Series A, Biological sciences and medical sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 105 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
105citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 2% of its field
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.

NCT02065245 phase1 / phase2completednot on this map

A Phase I/II, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Aging Frailty

TypeinterventionalSponsorLongeveron Inc.Ran2014 to 2020Enrolled65ConditionsFrailtyArmsAllogeneic Human Mesenchymal Stem Cells (allo-hMSCs), Placebo, Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)
NCT03514537 nasuspendednot on this mapstarted 2018, after this paper: background citation

Use of Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Cases Of Frailty and Aging Processes Using Autologous Stem-Stromal Cell Infusion in Patients With Aging Frailty And Wellness

TypeinterventionalSponsorHealeon Medical IncRan2018 to 2028Enrolled200ConditionsFrail Elderly Syndrome, Aging, Degenerative DiseaseArmsMicrocannula harvest adipose stromal tissues, Centricyte 1000, Sterile Normal Saline IV Deployment of cSVF, Liberase, Saline Solution
NCT04770350 early_phase1unknown statusnot on this mapstarted 2023, after this paper: background citation

Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty

TypeinterventionalSponsorNeurological Associates of West Los AngelesRan2023 to 2024Enrolled50ConditionsFrailty, AgingArmsFocused Ultrasound
NCT04919135 phase1 / phase2completednot on this mapstarted 2021, after this paper: background citation

Clinical Study of Mesenchymal Stem/Stromal Cell Therapy in Frailty: a Proposed Experimental Design for Therapeutic and Mechanism Investigation

TypeinterventionalSponsorVinmec Research Institute of Stem Cell and Gene TechnologyRan2021 to 2024Enrolled158ConditionsFrailtyArmsUmbilical Cord Mesenchymal Stem Cells transplantation, standard frailty treatment and supplementary medication
NCT05018767 phase1recruitingnot on this mapstarted 2022, after this paper: background citation

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Aging Frailty

TypeinterventionalSponsorThe Foundation for Orthopaedics and Regenerative MedicineRan2022 to 2027Enrolled86ConditionsFrailtyArmsAlloRx
3 · Its place in the literature

Who cites it

105 citing papers in PubMed, 2 syntheses or guidelines pooled it, 154 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  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. Trial
  9. Article
  10. Review
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  12. Article
  13. Mesenchymal stem cells for recurrent miscarriage.Journal of translational medicine · 2026
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article

45 more citing papers are in PubMed but not listed here.

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

30 authors at 3 institutions in 2 countries.

Bryon A TompkinsThe Interdisciplinary Stem Cell Institute.
Darcy L DiFedeThe Interdisciplinary Stem Cell Institute.
Aisha KhanThe Interdisciplinary Stem Cell Institute.
Ana Marie LandinThe Interdisciplinary Stem Cell Institute.
Ivonne Hernandez SchulmanThe Interdisciplinary Stem Cell Institute.
Marietsy V PujolThe Interdisciplinary Stem Cell Institute.
Alan W HeldmanThe Interdisciplinary Stem Cell Institute.
Roberto MikiDepartment of Medicine, University of Miami Miller School of Medicine, Florida.
Pascal J Goldschmidt-ClermontDepartment of Medicine, University of Miami Miller School of Medicine, Florida.
Bradley J GoldsteinThe Interdisciplinary Stem Cell Institute.
Muzammil MushtaqDepartment of Medicine, University of Miami Miller School of Medicine, Florida.
Silvina Levis-DusseauDepartment of Medicine, University of Miami Miller School of Medicine, Florida.
John J ByrnesDepartment of Medicine, University of Miami Miller School of Medicine, Florida.
Maureen LoweryDepartment of Medicine, University of Miami Miller School of Medicine, Florida.
Makoto NatsumedaThe Interdisciplinary Stem Cell Institute.
Cindy DelgadoThe Interdisciplinary Stem Cell Institute.
Russell SaltzmanThe Interdisciplinary Stem Cell Institute.
Mayra Vidro-CasianoThe Interdisciplinary Stem Cell Institute.
Moisaniel Da FonsecaThe Interdisciplinary Stem Cell Institute.
Samuel GolpanianDepartment of Surgery.
Courtney PremerThe Interdisciplinary Stem Cell Institute.
Audrey MedinaThe Interdisciplinary Stem Cell Institute.
Krystalenia ValasakiThe Interdisciplinary Stem Cell Institute.
Victoria FloreaThe Interdisciplinary Stem Cell Institute.
Erica AndersonEMMES Corporation, Rockville, Maryland.
Jill El-KhorazatyEMMES Corporation, Rockville, Maryland.
Adam MendizabalEMMES Corporation, Rockville, Maryland.
Geoff GreenLongeveron LLC, Miami, Florida.
Anthony A OlivaLongeveron LLC, Miami, Florida.
Joshua M HareThe Interdisciplinary Stem Cell Institute.
Stem Cell Institute · PAUniversity of Miami · USEmmes (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAging frailty, characterized by decreased physical and immunological functioning, is associated with stem cell depletion. Human allogeneic mesenchymal stem cells (allo-hMSCs) exert immunomodulatory effects and promote tissue repair.

methodsThis is a randomized, double-blinded, dose-finding study of intravenous allo-hMSCs (100 or 200-million [M]) vs placebo delivered to patients (n = 30, mean age 75.5 ± 7.3) with frailty. The primary endpoint was incidence of treatment-emergent serious adverse events (TE-SAEs) at 1-month postinfusion. Secondary endpoints included physical performance, patient-reported outcomes, and immune markers of frailty measured at 6 months postinfusion.

resultsNo therapy-related TE-SAEs occurred at 1 month. Physical performance improved preferentially in the 100M-group; immunologic improvement occurred in both the 100M- and 200M-groups. The 6-minute walk test, short physical performance exam, and forced expiratory volume in 1 second improved in the 100M-group (p = .01), not in the 200M- or placebo groups. The female sexual quality of life questionnaire improved in the 100M-group (p = .03). Serum TNF-α levels decreased in the 100M-group (p = .03). B cell intracellular TNF-α improved in both the 100M- (p < .0001) and 200M-groups (p = .002) as well as between groups compared to placebo (p = .003 and p = .039, respectively). Early and late activated T-cells were also reduced by MSC therapy.

conclusionIntravenous allo-hMSCs were safe in individuals with aging frailty. Treated groups had remarkable improvements in physical performance measures and inflammatory biomarkers, both of which characterize the frailty syndrome. Given the excellent safety and efficacy profiles demonstrated in this study, larger clinical trials are warranted to establish the efficacy of hMSCs in this multisystem disorder. CLINICAL

trial registrationwww.clinicaltrials.gov: CRATUS (#NCT02065245).

Indexed as

Frail ElderlyImmunity, InnateAgedAged, 80 and overAgingDouble-Blind MethodFemaleFollow-Up StudiesHumansInfusions, IntravenousMaleMesenchymal Stem Cell TransplantationMiddle AgedRegenerative MedicineTransplantation, HomologousTreatment OutcomeImmunomodulationRegenerative medicineTumor necrosis factor-α

Identifiers

PMID28977399
PMCPMC5861900
OpenAlexW2734481251

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.