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. 2023 Jun 6;6(6):CD013532.
doi: 10.1002/14651858.CD013532.pub2.

Granulocyte colony-stimulating factor with or without stem or progenitor cell or growth factors infusion for people with compensated or decompensated advanced chronic liver disease

Agostino Colli  1 , Mirella Fraquelli  2 , Daniele Prati  3 , Giovanni Casazza  4   5
Affiliations

Granulocyte colony-stimulating factor with or without stem or progenitor cell or growth factors infusion for people with compensated or decompensated advanced chronic liver disease

Agostino Colli et al. Cochrane Database Syst Rev. .

Abstract

Background: Advanced chronic liver disease is characterised by a long compensated phase followed by a rapidly progressive 'decompensated' phase, which is marked by the development of complications of portal hypertension and liver dysfunction. Advanced chronic liver disease is considered responsible for more than one million deaths annually worldwide. No treatment is available to specifically target fibrosis and cirrhosis; liver transplantation remains the only curative option. Researchers are investigating strategies to restore liver functionality to avoid or slow progression towards end-stage liver disease. Cytokine mobilisation of stem cells from the bone marrow to the liver could improve liver function. Granulocyte colony-stimulating factor (G-CSF) is a 175-amino-acid protein currently available for mobilisation of haematopoietic stem cells from the bone marrow. Multiple courses of G-CSF, with or without stem or progenitor cell or growth factors (erythropoietin or growth hormone) infusion, might be associated with accelerated hepatic regeneration, improved liver function, and survival.

Objectives: To evaluate the benefits and harms of G-CSF with or without stem or progenitor cell or growth factors (erythropoietin or growth hormone) infusion, compared with no intervention or placebo in people with compensated or decompensated advanced chronic liver disease.

Search methods: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, three other databases, and two trial registers (October 2022) together with reference-checking and web-searching to identify additional studies. We applied no restrictions on language and document type.

Selection criteria: We only included randomised clinical trials comparing G-CSF, independent of the schedule of administration, as a single treatment or combined with stem or progenitor cell infusion, or with other medical co-interventions, with no intervention or placebo, in adults with chronic compensated or decompensated advanced chronic liver disease or acute-on-chronic liver failure. We included trials irrespective of publication type, publication status, outcomes reported, or language.

Data collection and analysis: We followed standard Cochrane procedures. All-cause mortality, serious adverse events, and health-related quality of life were our primary outcomes, and liver disease-related morbidity, non-serious adverse events, and no improvement of liver function scores were our secondary outcomes. We undertook meta-analyses, based on intention-to-treat, and presented results using risk ratios (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, with 95% confidence intervals (CI) and I2 statistic values as a marker of heterogeneity. We assessed all outcomes at maximum follow-up. We determined the certainty of evidence using GRADE, evaluated the risk of small-study effects in regression analyses, and conducted subgroup and sensitivity analyses.

Main results: We included 20 trials (1419 participants; sample size ranged from 28 to 259), which lasted between 11 and 57 months. Nineteen trials included only participants with decompensated cirrhosis; in one trial, 30% had compensated cirrhosis. The included trials were conducted in Asia (15), Europe (four), and the USA (one). Not all trials provided data for our outcomes. All trials reported data allowing intention-to-treat analyses. The experimental intervention consisted of G-CSF alone or G-CSF plus any of the following: growth hormone, erythropoietin, N-acetyl cysteine, infusion of CD133-positive haemopoietic stem cells, or infusion of autologous bone marrow mononuclear cells. The control group consisted of no intervention in 15 trials and placebo (normal saline) in five trials. Standard medical therapy (antivirals, alcohol abstinence, nutrition, diuretics, β-blockers, selective intestinal decontamination, pentoxifylline, prednisolone, and other supportive measures depending on the clinical status and requirement) was administered equally to the trial groups. Very low-certainty evidence suggested a decrease in mortality with G-CSF, administered alone or in combination with any of the above, versus placebo (RR 0.53, 95% CI 0.38 to 0.72; I2 = 75%; 1419 participants; 20 trials). Very low-certainty evidence suggested no difference in serious adverse events (G-CSF alone or in combination versus placebo: RR 1.03, 95% CI 0.66 to 1.61; I2 = 66%; 315 participants; three trials). Eight trials, with 518 participants, reported no serious adverse events. Two trials, with 165 participants, used two components of the quality of life score for assessment, with ranges from 0 to 100, where higher scores indicate better quality of life, with a mean increase from baseline of the physical component summary of 20.7 (95% CI 17.4 to 24.0; very low-certainty evidence) and a mean increase from baseline of the mental component summary of 27.8 (95% CI 12.3 to 43.3; very low-certainty evidence). G-CSF, alone or in combination, suggested a beneficial effect on the proportion of participants who developed one or more liver disease-related complications (RR 0.40, 95% CI 0.17 to 0.92; I2 = 62%; 195 participants; four trials; very low-certainty evidence). When we analysed the occurrences of single complications, there was no suggestion of a difference between G-CSF, alone or in combination, versus control, in participants in need of liver transplantation (RR 0.85, 95% CI 0.39 to 1.85; 692 participants; five trials), in the development of hepatorenal syndrome (RR 0.65, 95% CI 0.33 to 1.30; 520 participants; six trials), in the occurrence of variceal bleeding (RR 0.68, 95% CI 0.37 to 1.23; 614 participants; eight trials), and in the development of encephalopathy (RR 0.56, 95% CI 0.31 to 1.01; 605 participants; seven trials) (very low-certainty evidence). The same comparison suggested that G-CSF reduces the development of infections (including sepsis) (RR 0.50, 95% CI 0.29 to 0.84; 583 participants; eight trials) and does not improve liver function scores (RR 0.67, 95% CI 0.53 to 0.86; 319 participants; two trials) (very low-certainty evidence).

Authors' conclusions: G-CSF, alone or in combination, seems to decrease mortality in people with decompensated advanced chronic liver disease of whatever aetiology and with or without acute-on-chronic liver failure, but the certainty of evidence is very low because of high risk of bias, inconsistency, and imprecision. The results of trials conducted in Asia and Europe were discrepant; this could not be explained by differences in participant selection, intervention, and outcome measurement. Data on serious adverse events and health-related quality of life were few and inconsistently reported. The evidence is also very uncertain regarding the occurrence of one or more liver disease-related complications. We lack high-quality, global randomised clinical trials assessing the effect of G-CSF on clinically relevant outcomes.

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Conflict of interest statement

AC: has declared that they have no conflict of interest. MF: has declared that they have no conflict of interest. DP: has declared that they have no conflict of interest. GC: has declared that they have no conflict of interest.

Figures

1
1
Study flow diagram. Date of search: 4 October 2022
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Funnel plot of G‐CSF compared with no intervention or placebo; outcome: 1.1 All‐cause mortality. Visual inspection seemed to suggest presence of publication bias arising from data missing from the bottom left of the distribution. When performing a formal analysis with the Rücker test (Rücker 2008), we found no statistically significant asymmetry (P = 0.0964)
5
5
All‐cause mortality. Twenty trials (1419 participants) provided data. The diversity‐adjusted required information size (DARIS) was calculated based on all‐cause mortality of 44.3% in the control group; relative risk reduction (RRR) in the G‐CSF group of 15%; type I error of 2.5%; type II error of 10% (90% power). Trial diversity was 75.79%. The required information size was 11,216 participants. The blue line represents the cumulative Z‐score of the cumulative meta‐analysis. The green dotted lines show the conventional boundaries of the nominal alpha level of 5%. The two pieces of red inward‐sloping lines represent the trial sequential monitoring boundaries.
1.1
1.1. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 1: Mortality
1.2
1.2. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 2: Mortality (subgroup analysis): risk of bias
1.3
1.3. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 3: Mortality (subgroup analysis) based on G‐CSF alone or with other treatments
1.4
1.4. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 4: Mortality (subgroup analysis): ALD and other liver diseases
1.5
1.5. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 5: Mortality (subgroup analysis): ACLF and no ACLF
1.6
1.6. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 6: Mortality (subgroup analysis): short and long course
1.7
1.7. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 7: Mortality (subgroup analysis): long and short follow‐up
1.8
1.8. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 8: Mortality (subgroup analysis): based on continents
1.9
1.9. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 9: Mortality (sensitivity analysis): only full‐text publications
1.10
1.10. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 10: Mortality (sensitivity analysis): best/worst case scenario
1.11
1.11. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 11: Mortality (sensitivity analysis): worst/best case scenario
1.12
1.12. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 12: Serious adverse events
1.13
1.13. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 13: Quality of life: PCS or MCS ‐ change from baseline
1.14
1.14. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 14: Proportion of participants who developed one or more liver disease‐related complications
1.15
1.15. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 15: Othotopic liver transplantation
1.16
1.16. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 16: Hepatorenal syndrome
1.17
1.17. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 17: Variceal bleeding
1.18
1.18. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 18: Encephalopathy
1.19
1.19. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 19: Infection (including sepsis)
1.20
1.20. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 20: Proportion of participants with adverse events considered to be non‐serious
1.21
1.21. Analysis
Comparison 1: Granulocyte colony‐stimulating factor (G‐CSF) with or without stem or progenitor cell infusion versus placebo or no intervention for people with compensated or decompensated advanced chronic liver disease, Outcome 21: Proportion of participants without improvement in liver function scores
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References

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References to other published versions of this review

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