Evidence map›Paper›PMID 34395335›Full record

Trial reportCanadian journal of gastroenterology & hepatology2021

Bone Marrow Mesenchymal Stem Cells in Acute-on-Chronic Liver Failure Grades 2 and 3: A Phase I-II Randomized Clinical Trial.

Fernando Comunello Schacher, Annelise Martins Pezzi da Silva, Lucia Mariano da Rocha Silla, Mario Reis Álvares-da-Silva

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

Trial report in Canadian journal of gastroenterology & hepatology, 2021. 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 37 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 4 pooled it
4.9field-weighted citation impact, top 3% 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.

NCT05985863 phase1 / phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Clinical Research of Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure

TypeinterventionalSponsorBeijing 302 HospitalRan2023 to 2028Enrolled150ConditionsAcute-On-Chronic Liver FailureArmsstandard medical treatment, Placebo, hUC-MSC, hUC-MSC_Prolonged
NCT06740149 phase1 / phase2completednot on this mapstarted 2023, after this paper: background citation

Efficacy and Safety of Allogeneic Human Bone Marrow Mesenchymal Stem Cells for the Treatment of Patients With Acute-on-chronic Liver Failure

TypeinterventionalSponsorSun Yat-sen UniversityRan2023 to 2026Enrolled90ConditionsAcute-On-Chronic Liver FailureArmsBone marrow mesenchymal stem cells (low dose), Solvent of CG-BM1, Bone marrow mesenchymal stem cells (medium dose), Bone marrow mesenchymal stem cells (high dose)
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 4 syntheses or guidelines pooled it, 57 citations in OpenAlex.

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  18. [Interventional studies on acute-on-chronic liver failure: challenges and opportunities].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
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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

4 authors at 2 institutions in 1 country.

Fernando Comunello SchacherGraduate Program Sciences in Gastroenterology and Hepatology, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.ORCID 0000-0002-6991-1174
Annelise Martins Pezzi da SilvaHematology Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Lucia Mariano da Rocha SillaHematology Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Mario Reis Álvares-da-SilvaGraduate Program Sciences in Gastroenterology and Hepatology, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Hospital de Clínicas de Porto Alegre · BRUniversidade Federal do Rio Grande do Sul · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Acute-on-chronic liver failure (ACLF) is an acute liver decompensation in cirrhotic patients, which leads to organ failures and high short-term mortality. The treatment is based on the management of complications and, in severe cases, liver transplantation. Since specific treatment is unavailable, we aimed to evaluate the safety and initial efficacy of bone marrow mesenchymal stem cells (BM-MSC) in patients with ACLF Grades 2 and 3, a population excluded from previous clinical trials. Methods: This is a randomized placebo-controlled phase I-II single center study, which enrolled 9 cirrhotic patients from 2018 to 2020, regardless of the etiology. The control group ( Results: Nine patients with a mean Child-Pugh (CP) of 12.3, MELD of 38.4, and CLIF-C score of 50.7 were recruited. Hepatitis C and alcohol were the main etiologies. The average infusion per patient was 2.9 and only 3 patients (2 in control and 1 in the BM-MSC group) received all the protocol infusions. There were no infusion-related side effects, although one patient in the intervention group presented hypernatremia and a gastric ulcer, after the third and fifth infusions, respectively. The survival rate after 90 days was 20% (1/5) for placebo versus 25% (1/4) for the BM-MSC. The patient who completed the entire MSC protocol showed a significant improvement in CP (C-14 to B-9), MELD (32 to 22), and ACLF (grade 3 to 0). Conclusion: BM-MSC infusion is safe and feasible in patients with ACLF Grades 2 and 3.

Indexed as

Acute-On-Chronic Liver FailureMesenchymal Stem CellsHumansPrognosisStatistics, NonparametricSurvival AnalysisSurvival Rate

Identifiers

PMID34395335
PMCPMC8357501
OpenAlexW3187996904

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.