Evidence map›Paper›PMID 34169246›Full record

ArticleJHEP reports : innovation in hepatology2021

A phase II study of human allogeneic liver-derived progenitor cell therapy for acute-on-chronic liver failure and acute decompensation.

Frederik Nevens, Thierry Gustot, Pierre-François Laterre, Luc L Lasser, Lyudmil E Haralampiev, Victor Vargas, Desislava Lyubomirova, Agustin Albillos, Mustapha Najimi, Sébastien Michel and 6 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in JHEP reports : innovation in hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.8field-weighted citation impact, top 5% 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.

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

21 citing papers in PubMed, 39 citations in OpenAlex.

  1. Review
  2. Article
  3. Potential therapies for acute-on-chronic liver failure.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Review
  4. Article
  5. [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
    Article
  6. Article
  7. Review
  8. Stem cell therapy for hepatocellular carcinoma and end-stage liver disease.Journal of the Egyptian National Cancer Institute · 2023
    Review
  9. Review
  10. Review
  11. Acute-on-chronic liver failure: far to go-a review.Critical care (London, England) · 2023
    Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Liver cirrhosis and immune dysfunction.International immunology · 2022
    Review
  17. Review
  18. Review
  19. Organoid transplant approaches for the liver.Transplant international : official journal of the European Society for Organ Transplantation · 2021
    Review
  20. Acute-on-Chronic Liver Failure in Cirrhosis.Journal of clinical medicine · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 3 countries.

Frederik NevensDepartment of Gastroenterology and Hepatology, University Hospitals, KU Leuven, Belgium.
Thierry GustotDepartment of Gastroenterology and Hepato-Pancreatology, C.U.B. Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Pierre-François LaterreIntensive Care Unit, Cliniques Universitaires Saint-Luc, UCLouvain, Brussels, Belgium.
Luc L LasserGastroenterology Clinic, CHU Brugmann, Brussels, Belgium.
Lyudmil E HaralampievDepartment of Internal Diseases, Multiprofile Hospital for Active Treatment (MEDICA), Ruse, Bulgaria.
Victor VargasLiver Unit, Hospital Vall d'Hebron, Universitat Autònoma Barcelona, CIBERehd, Barcelona, Spain.
Desislava LyubomirovaDepartment of Clinical Gastroenterology with Hepatology, Gastroenterology Clinic, University Multiprofile Hospital for Active Treatment "Georgi Stranski", Pleven, Bulgaria.
Agustin AlbillosGastroenterology and Hepatology, University Hospital Ramón y Cajal, Madrid, Spain.
Mustapha NajimiUCLouvain, Institute of Experimental and Clinical Research (IREC), Laboratory of Pediatric Hepatology and Cell Therapy (PEDI), Brussels, Belgium.
Sébastien MichelPromethera Biosciences, Mont-Saint-Guibert, Belgium.
Ivaylo StoykovPromethera Biosciences, Mont-Saint-Guibert, Belgium.
Noelia GordilloPromethera Biosciences, Mont-Saint-Guibert, Belgium.
Yelena VainilovichPromethera Biosciences, Mont-Saint-Guibert, Belgium.
Virginie BarthelPromethera Biosciences, Mont-Saint-Guibert, Belgium.
Nathalie Clerget-ChossatPromethera Biosciences, Mont-Saint-Guibert, Belgium.
Etienne M SokalUCLouvain, Institute of Experimental and Clinical Research (IREC), Laboratory of Pediatric Hepatology and Cell Therapy (PEDI), Brussels, Belgium.
Promethera Biosciences (Belgium) · BECliniques Universitaires Saint-Luc · BECentre Hospitalier Universitaire Brugmann · BEHospital Universitario Ramón y Cajal · ESKU Leuven · BENational Institute of Emergency Medicine "Pirogov" · BGUniversitat Autònoma de Barcelona · ESUniversité Libre de Bruxelles · BEUniversity Hospital Dr. Georgi Stranski · BG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsHuman allogeneic liver-derived progenitor cells (HALPC, HepaStem®; Promethera Biosciences, Mont-Saint-Guibert, Belgium) are an advanced therapy medicinal product that could potentially alleviate systemic inflammation and ameliorate liver function in patients with acute-on-chronic liver failure (ACLF) or acute decompensation of cirrhosis (AD).

methodsThis open-label phase II study was conducted in 9 centres in Belgium, Spain, and Bulgaria between 2016 and 2019. The primary objective was to assess the safety of HALPC therapy up to Day 28 and the secondary objectives were to assess its safety and preliminary efficacy up to Month 3.

resultsThe 24 treated patients (mean age: 51 years) were mostly male with an alcoholic cirrhosis. On pre-infusion Day 1, 15 patients had ACLF and 9 patients had AD. Two of the 3 initial patients treated with high HALPC doses (∼5×10

conclusionsThe treatment of patients with ACLF or AD with up to 2 doses of 1.2×10 CLINICAL TRIALS REGISTRATION: EudraCT 2016-001177-32. LAY SUMMARY: Patients with liver cirrhosis may suffer from the rapid onset of organ failure or multiple organ failure associated with a high risk of death in the short term. This clinical study of 24 patients suggests that an advanced therapy based on the intravenous infusion of low doses of human allogeneic liver-derived progenitor cells is safe and supports the next phase of clinical development of this type of therapy.

Indexed as

ACLF, acute-on-chronic liver failureAD, acute decompensation of liver cirrhosisAE, adverse eventAESI, AE of special interestAlcoholic liver diseaseATMP, advanced therapy medicinal productBW, body weightCRP, C-reactive proteinEASL-CLIF, European Association for the Study of Chronic Liver FailureHALPC, human allogeneic liver-derived progenitor cellsINR, international normalised ratioi.v., intravenousLiver regenerative medicineMELD, model for end-stage liver diseaseMSC, mesenchymal stem cellsSAE, serious AESAS, safety analysis setStem cellSUSAR, suspected unexpected serious adverse reactionTEG, thromboelastographyTGT, thrombin generation test

Identifiers

PMID34169246
PMCPMC8207211
OpenAlexW3153609333

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.