Evidence map›Paper›PMID 24708472›Full record

Trial reportRespiratory research2014

Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study.

Guoping Zheng, Lanfang Huang, Haijiang Tong, Qiang Shu, Yaoqin Hu, Menghua Ge, Keqin Deng, Liuya Zhang, Bin Zou, Baoli Cheng and 1 more

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 265 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
265citing papers in PubMed, 14 pooled it
18.3field-weighted citation impact, top 1% 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.

NCT01902082 phase1unknown statusnot on this map

Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

TypeinterventionalSponsorShaoxing Second HospitalRan2012 to 2014Enrolled20ConditionsARDSArmsMesenchymal stem cells, Placebo
NCT06163833 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury

TypeinterventionalSponsorFondazione IRCCS San Gerardo dei TintoriRan2023 to 2026Enrolled78ConditionsTraumatic Brain Injury With Loss of ConsciousnessArmsMesenchymal stromal cell low dosage-80*10^6 cells, Mesenchymal stromal cell low dosage-160*10^6 cells, Placebo-storage solution
3 · Its place in the literature

Who cites it

265 citing papers in PubMed, 14 syntheses or guidelines pooled it, 459 citations in OpenAlex.

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  10. Between-trial heterogeneity in ARDS research.Intensive care medicine · 2021
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205 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

11 authors at 3 institutions in 1 country.

Guoping Zheng
Lanfang Huang
Haijiang Tong
Qiang Shu
Yaoqin Hu
Menghua Ge
Keqin Deng
Liuya Zhang
Bin Zou
Baoli Cheng
Jianguo XuShaoxing Second Hospital, 123 Yan An Road, Shaoxing, Zhejiang 312000, China. jxu5@yahoo.com.
Shaoxing Second Hospital · CNChildren's Hospital of Zhejiang University · CNFirst Affiliated Hospital Zhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent studies have demonstrated that mesenchymal stem cells (MSCs) modulate the immune response and reduce lung injury in animal models. Currently, no clinical studies of the effects of MSCs in acute respiratory distress syndrome (ARDS) exist. The objectives of this study were first to examine the possible adverse events after systemic administration of allogeneic adipose-derived MSCs in ARDS patients and second to determine potential efficacy of MSCs on ARDS.

methodsTwelve adult patients meeting the Berlin definition of acute respiratory distress syndrome with a PaO2/FiO2 ratio of < 200 were randomized to receive allogeneic adipose-derived MSCs or placebo in a 1:1 fashion. Patients received one intravenous dose of 1 × 106 cells/kg of body weight or saline. Possible side effects were monitored after treatment. Acute lung injury biomarkers, including IL-6, IL-8 and surfactant protein D (SP-D), were examined to determine the effects of MSCs on lung injury and inflammation.

resultsThere were no infusion toxicities or serious adverse events related to MSCs administration and there were no significant differences in the overall number of adverse events between the two groups. Length of hospital stay, ventilator-free days and ICU-free days at day 28 after treatment were similar. There were no changes in biomarkers examined in the placebo group. In the MSCs group, serum SP-D levels at day 5 were significantly lower than those at day 0 (p = 0.027) while the changes in IL-8 levels were not significant. The IL-6 levels at day 5 showed a trend towards lower levels as compared with day 0, but this trend was not statistically significant (p = 0.06).

conclusionsAdministration of allogeneic adipose-derived MSCs appears to be safe and feasible in the treatment of ARDS. However, the clinical effect with the doses of MSCs used is weak, and further optimization of this strategy will probably be required to reach the goal of reduced alveolar epithelial injury in ARDS.

trial registrationClinical trials.gov, NCT01902082.

Indexed as

Adipose TissueAgedAged, 80 and overAnimalsCells, CulturedDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiceMice, Inbred C57BLMiddle AgedPilot Projects

Identifiers

PMID24708472
PMCPMC3994204
OpenAlexW2138201661

What OpenQuestion holds

Textmetadata
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.