Evidence map›Paper›PMID 28444181›Full record

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

Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty.

Samuel Golpanian, Darcy L DiFede, Aisha Khan, Ivonne Hernandez Schulman, Ana Marie Landin, Bryon A Tompkins, Alan W Heldman, Roberto Miki, Bradley J Goldstein, Muzammil Mushtaq and 20 more

3 registry-linked trialsAbstract readClinical 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 3 registered trials, which are not on this map. Cited by 68 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 2 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.

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
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

68 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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8 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.

Samuel GolpanianThe Interdisciplinary Stem Cell Institute.
Darcy L DiFedeLongeveron LLC, Miami, Florida.
Aisha KhanThe Interdisciplinary Stem Cell Institute.
Ivonne Hernandez SchulmanThe Interdisciplinary Stem Cell Institute.
Ana Marie LandinThe Interdisciplinary Stem Cell Institute.
Bryon A TompkinsThe Interdisciplinary Stem Cell Institute.
Alan W HeldmanThe Interdisciplinary Stem Cell Institute.
Roberto MikiDepartment 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.
Marietsy V PujolThe Interdisciplinary Stem Cell Institute.
Moisaniel Da FonsecaThe Interdisciplinary Stem Cell Institute.
Anthony A OlivaLongeveron LLC, Miami, Florida.
Geoff GreenLongeveron LLC, Miami, Florida.
Courtney PremerThe Interdisciplinary Stem Cell Institute.
Audrey MedinaLongeveron LLC, Miami, Florida.
Krystalenia ValasakiThe Interdisciplinary Stem Cell Institute.
Victoria FloreaThe Interdisciplinary Stem Cell Institute.
Erica AndersonThe Emmes Corporation, Rockville, Maryland.
Jill El-KhorazatyThe Emmes Corporation, Rockville, Maryland.
Adam MendizabalThe Emmes Corporation, Rockville, Maryland.
Pascal J Goldschmidt-ClermontDepartment of Medicine, University of Miami Miller School of Medicine, Florida.
Joshua M HareThe Interdisciplinary Stem Cell Institute.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImpaired endogenous stem cell repair capacity is hypothesized to be a biologic basis of frailty. Therapies that restore regenerative capacity may therefore be beneficial. This Phase 1 study evaluated the safety and potential efficacy of intravenous, allogeneic, human mesenchymal stem cell (allo-hMSC)-based therapy in patients with aging frailty.

methodsIn this nonrandomized, dose-escalation study, patients received a single intravenous infusion of allo-hMSCs: 20-million (n = 5), 100-million (n = 5), or 200-million cells (n = 5). The primary endpoint was incidence of any treatment-emergent serious adverse events measured at 1 month postinfusion. The secondary endpoints were functional efficacy domains and inflammatory biomarkers, measured at 3 and 6 months, respectively.

resultsThere were no treatment-emergent serious adverse events at 1-month postinfusion or significant donor-specific immune reactions during the first 6 months. There was one death at 258 days postinfusion in the 200-million group. In all treatment groups, 6-minute walk distance increased at 3 months (p = .02) and 6 months (p = .001) and TNF-α levels decreased at 6 months (p < .0001). Overall, the 100-million dose showed the best improvement in all parameters, with the exception of TNF-α, which showed an improvement in both the 100- and 200-million groups (p = .0001 and p = .0001, respectively). The 100-million cell-dose group also showed significant improvements in the physical component of the SF-36 quality of life assessment at all time points relative to baseline.

conclusionsAllo-hMSCs are safe and immunologically tolerated in aging frailty patients. Improvements in functional and immunologic status suggest that ongoing clinical development of cell-based therapy is warranted for frailty.

Indexed as

AgingFrail ElderlyAgedAged, 80 and overFemaleFollow-Up StudiesHumansInfusions, IntravenousMaleMesenchymal Stem Cell TransplantationPilot ProjectsRegenerative MedicineTransplantation, HomologousCell-based therapyInflammationPhysical functionRegenerative medicine

Identifiers

PMID28444181
PMCPMC5861970

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.