Evidence map›Paper›PMID 35002228›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Autologous Infusion of Bone Marrow and Mesenchymal Stromal Cells in Patients with Chronic Obstructive Pulmonary Disease: Phase I Randomized Clinical Trial.

Selma Denis Squassoni, Eliseo Joji Sekiya, Elie Fiss, Monica Silveira Lapa, Daniela Dos Santos Cayetano, Flávia Nascimento, Adelson Alves, Nadine Cristina Machado, Bruna Escaramboni, Francislaine Aparecida Dos Reis Lívero and 6 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Regenerative and translational medicine in COPD: hype and hope.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  7. Genomic instability in long-term culture of human adipose-derived mesenchymal stromal cells.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2023
    Article
  8. Review
  9. Review
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

16 authors.

Selma Denis SquassoniABC Medical School, São Paulo, SP, Brazil.
Eliseo Joji Sekiya *São Lucas Research and Education Institute (IEP-Sao Lucas), TechLife, São Paulo, SP, Brazil.
Elie FissABC Medical School, São Paulo, SP, Brazil.
Monica Silveira LapaABC Medical School, São Paulo, SP, Brazil.
Daniela Dos Santos CayetanoSão Lucas Research and Education Institute (IEP-Sao Lucas), TechLife, São Paulo, SP, Brazil.
Flávia NascimentoSão Lucas Research and Education Institute (IEP-Sao Lucas), TechLife, São Paulo, SP, Brazil.ORCID 0000-0002-0061-0517
Adelson AlvesSão Lucas Research and Education Institute (IEP-Sao Lucas), TechLife, São Paulo, SP, Brazil.
Nadine Cristina MachadoABC Medical School, São Paulo, SP, Brazil.
Bruna EscaramboniSão Paulo State University (UNESP), Assis, SP, Brazil.ORCID 0000-0002-2285-3624
Francislaine Aparecida Dos Reis LíveroParanaense University (UNIPAR), Umuarama, PR, Brazil.ORCID 0000-0001-6533-0850
Maria José Malagutti-FerreiraSão Paulo State University (UNESP), Assis, SP, Brazil.ORCID 0000-0001-5174-5502
Murilo Racy SoaresDepartment of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (USP), Ribeirão Preto, SP, Brazil.ORCID 0000-0002-4190-495X
Francisco Winter Dos Santos FigueiredoABC Medical School, São Paulo, SP, Brazil.
Beatriz Kimberly Nath KramerSão Paulo State University (UNESP), Assis, SP, Brazil.
Priscila Megda João Job ZagoParanaense University (UNIPAR), Umuarama, PR, Brazil.
João Tadeu Ribeiro-Paes *São Paulo State University (UNESP), Assis, SP, Brazil.ORCID 0000-0002-7645-5891

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesChronic obstructive pulmonary disease (COPD) is characterized by the destruction of alveolar walls, chronic inflammation and persistent respiratory symptoms. There is no curative clinical treatment for COPD. In this context, cell-based therapy is a promising therapeutic alternative for COPD. Thus, in this open, controlled and randomized Phase I Clinical Trial, we aimed to assess the safety of the infusion of autologous bone marrow mononuclear cells (BMMC), adipose-derived mesenchymal stromal cells (ADSC) and, especially, the safety of concomitant infusion (co-infusion) of BMMC and ADSC as a new therapeutic alternative for COPD. The rationale for co-infusion of BMMC and ADSC is based on the hypothesis of an additive or synergistic therapeutic effect resulting from this association.

methodsTo achieve the proposed objectives, twenty patients with moderate-to-severe COPD were randomly divided into four groups: control group - patients receiving conventional treatment; BMMC group - patients receiving only BMMC; ADSC group - patients receiving only ADSC, and co-infusion group - patients receiving the concomitant infusion of BMMC and ADSC. Patients were assessed for pulmonary function, biochemical profile, and quality of life over a 12 months follow-up.

resultsNo adverse events were detected immediately after the infusion of BMMC, ADSC or co-infusion. In the 12-month follow-up, no causal relationship was established between adverse events and cell therapy procedures. Regarding the efficacy, the BMMC group showed an increase in forced expiratory volume (FEV1) and diffusing capacity for carbon monoxide (DLCO). Co-infusion group showed a DLCO, and gas exchange improvement and a better quality of life.

conclusionThe results obtained allow us to conclude that cell-based therapy with co-infusion of BMMC and ADSC is a safe procedure and a promising therapeutic for COPD. However, additional studies with a greater number of patients are needed before randomized and controlled Phase III clinical trials can be implemented.

Indexed as

Mesenchymal Stem CellsPulmonary Disease, Chronic ObstructiveBone MarrowForced Expiratory VolumeHumansQuality of Lifecell therapyco-infusionconcomitant infusionCOPDmesenchymal stem cellsstem cells

Identifiers

PMID35002228
PMCPMC8733220

What OpenQuestion holds

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Registered trials

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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.