Evidence map›Paper›PMID 23855653›Full record

ArticleJournal of translational medicine2013

A prospective, non-randomized, no placebo-controlled, phase Ib clinical trial to study the safety of the adipose derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis.

Argyris Tzouvelekis, Vassilis Paspaliaris, George Koliakos, Paschalis Ntolios, Evangelos Bouros, Anastasia Oikonomou, Athanassios Zissimopoulos, Nikolaos Boussios, Brian Dardzinski, Dimitrios Gritzalis and 4 more

3 registry-linked trialsAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of translational medicine, 2013. 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 143 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
143citing papers in PubMed, 10 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.

NCT02625246 phase1completednot on this mapstarted 2016, after this paper: background citation

A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell (hMSC) Infusion in Patients With Non-Cystic Fibrosis Bronchiectasis

TypeinterventionalSponsorMarilyn GlassbergRan2016 to 2019Enrolled6ConditionsBronchiectasisArmshMSCs
NCT03137199 phase1terminatednot on this mapstarted 2017, after this paper: background citation

A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Mild Asthma

TypeinterventionalSponsorMarilyn GlassbergRan2017 to 2020Enrolled3ConditionsAsthmaArmshMSCs
NCT05468502 phase1completednot on this mapstarted 2022, after this paper: background citation

An Open Clinical Study to Explore the Safety, Tolerance and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

TypeinterventionalSponsorShanghai Life Science & TechnologyRan2022 to 2025Enrolled17ConditionsIdiopathic Pulmonary FibrosisArmsHuman umbilical cord mesenchymal stem cell injection
3 · Its place in the literature

Who cites it

143 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
  2. Old and emerging therapies for childhood interstitial lung disease (chILD): a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2026
    Pooled it
  3. Pooled it
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  5. Health-related quality of life of patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2020
    Pooled it
  6. Prognosis of idiopathic pulmonary fibrosis without anti-fibrotic therapy: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2020
    Pooled it
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  11. Trial
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  20. From Epithelium to Therapy: Transitional Cells in Lung Fibrosis.American journal of respiratory cell and molecular biology · 2025
    Review

83 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

14 authors.

Argyris TzouvelekisDepartment of Pneumonology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.
Vassilis Paspaliaris
George Koliakos
Paschalis Ntolios
Evangelos Bouros
Anastasia Oikonomou
Athanassios Zissimopoulos
Nikolaos Boussios
Brian Dardzinski
Dimitrios Gritzalis
Antonis Antoniadis
Marios Froudarakis
George Kolios
Demosthenes Bouros

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRegenerative medicine and particular adult stem cells represent an alternative option with several fruitful therapeutic applications in patients suffering from chronic lung diseases including idiopathic pulmonary fibrosis (IPF). Nevertheless, lack of knowledge regarding the origin and the potential of mesenchymal stem cells (MSCs) to differentiate into fibroblasts has limited their use for the treatment of this dismal disease. PATIENTS AND

methodsTo this end, we conducted a phase Ib, non-randomized, clinical trial to study the safety of three endobronchial infusions of autologous adipose derived stromal cells (ADSCs)-stromal vascular fraction (SVF) (0.5 million cells per kgr of body weight per infusion) in patients with IPF (n=14) of mild to moderate disease severity (forced vital capacity -FVC>50% predicted value and diffusion lung capacity for carbon monoxide-DLCO>35% of predicted value). Our primary end-point was incidence of treatment emergent adverse events within 12 months. Alterations of functional, exercise capacity and quality of life parameters at serial time points (baseline, 6 and 12 months after first infusion) were exploratory secondary end-points.

resultsNo cases of serious or clinically meaningful adverse events including short-term infusional toxicities as well as long-term ectopic tissue formation were recorded in all patients. Detailed safety monitoring through several time-points indicated that cell-treated patients did not deteriorate in both functional parameters and indicators of quality of life.

conclusionsThe clinical trial met its primary objective demonstrating an acceptable safety profile of endobronchially administered autologous ADSCs-SVF. Our findings accelerate the rapidly expanded scientific knowledge and indicate a way towards future efficacy trials.

Indexed as

Adipose TissueAgedFemaleFlow CytometryHumansIdiopathic Pulmonary FibrosisInflammationLungMaleMesenchymal Stem CellsMiddle AgedProspective StudiesRadionuclide ImagingRespiratory Function TestsStromal Cells

Identifiers

PMID23855653
PMCPMC3722100

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.