Evidence map›Paper›PMID 33964910›Full record

Trial reportRespiratory research2021

Effect of mesenchymal stromal cell infusions on lung function in COPD patients with high CRP levels.

Daniel J Weiss, Karen Segal, Richard Casaburi, Jack Hayes, Donald Tashkin

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00683722 (A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL™), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
3.7field-weighted citation impact, top 6% 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.

NCT00683722 phase2completednot on this map

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL™ (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorMesoblast, Inc.Ran2008 to 2010Enrolled62ConditionsPulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Chronic BronchitisArmsProchymal™, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 33 citations in OpenAlex.

  1. Review
  2. Progenitor Resilience and the Early Onset of Chronic Lung Diseases: NHLBI workshop report.American journal of respiratory cell and molecular biology · 2026
    Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Stem cells, cell therapies, and bioengineering in lung biology and diseases 2023.American journal of physiology. Lung cellular and molecular physiology · 2024
    Review
  12. Viral airway injury promotes cell engraftment in an in vitro model of cystic fibrosis cell therapy.American journal of physiology. Lung cellular and molecular physiology · 2024
    Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. Liver-directedMolecular therapy. Methods & clinical development · 2022
    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

5 authors at 4 institutions in 1 country.

Daniel J WeissUniversity of Vermont College of Medicine, 226 Health Science Research Facility, Burlington, VT, 05405, USA. dweiss@uvm.edu.ORCID http://orcid.org/0000-0002-5515-8062
Karen SegalSSI Strategy New York, New York, NY, USA.
Richard CasaburiLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.
Jack HayesMesoblast, Inc., New York, NY, USA.
Donald TashkinUCLA David Geffen School of Medicine, Los Angeles, CA, USA.
Mesoblast (United States) · USUCLA Medical Center · USUniversity of California, Los Angeles · USUniversity of Vermont · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe previously reported a Phase 1/2 randomized placebo-controlled trial of systemic administration of bone marrow-derived allogeneic MSCs (remestemcel-L) in COPD. While safety profile was good, no functional efficacy was observed. However, in view of growing recognition of effects of inflammatory environments on MSC actions we conducted a post-hoc analysis with stratification by baseline levels of a circulating inflammatory marker, C-reactive protein (CRP) to determine the effects of MSC administration in COPD patients with varying circulating CRP levels.

methodsTime course of lung function, exercise performance, patient reported responses, and exacerbation frequency following four monthly infusions of remestemcel-L vs. placebo were re-assessed in subgroups based on baseline circulating CRP levels.

resultsIn COPD patients with baseline CRP ≥ 4 mg/L, compared to COPD patients receiving placebo (N = 17), those treated with remestemcel-L (N = 12), demonstrated significant improvements from baseline in forced expiratory volume in one second, forced vital capacity, and six minute walk distance at 120 days with treatment differences evident as early as 10 days after the first infusion. Significant although smaller benefits were also detected in those with CRP levels ≥ 2 or ≥ 3 mg/L. These improvements persisted variably over the 2-year observational period. No significant benefits were observed in patient reported responses or number of COPD exacerbations between treatment groups.

conclusionIn an inflammatory environment, defined by elevated circulating CRP, remestemcel-L administration yielded at least transient meaningful pulmonary and functional improvements. These findings warrant further investigation of potential MSC-based therapies in COPD and other inflammatory pulmonary diseases.

trial registrationClinicaltrials.gov NCT00683722.

Indexed as

Mesenchymal Stem Cell TransplantationAgedBiological ProductsBiomarkersC-Reactive ProteinExercise ToleranceFemaleForced Expiratory VolumeHumansLungMaleMesenchymal Stem CellsMiddle AgedPulmonary Disease, Chronic ObstructiveRecovery of FunctionTime FactorsBiological ProductsBiomarkersC-Reactive Proteinremestemcel-lChronic obstructive pulmonary diseaseC-reactive proteinInflammationMesenchymal stromal cellsPulmonary function

Identifiers

PMID33964910
PMCPMC8106850
OpenAlexW3161552852

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.