Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Granulocyte Colony Stimulating Factor in Decompensated Cirrhosis: an Open Label Study
Brief Summary: Globally, cirrhosis is the fifth commonest cause of mortality. Its natural history is typified by an initial, largely asymptomatic, "compensated" phase followed by "decompensation" due to complications of raised portal pressures and hepatocellular dysfunction.

Currently the only definitive treatment option for cirrhosis is liver transplantation which is limited in its applicability due to donor shortage, exorbitant costs and lack of widespread availability. The need for long term immunosuppression and its attendant complications are a further drawback. The ability of stem cells to differentiate into multiple cellular lineages makes one speculate that they can be used for tissue repair and regeneration when tissue-resident stem cells become overwhelmed. Bone marrow derived stem cells have amazing plasticity. They can "home" to the liver in response to injury and help in liver regeneration by trans-differentiation, cell fusion and augmentation of tissue- resident stem cell mediated repair. Two methods are available for the mobilisation of stem cells from the bone marrow to the liver. One involves the administration of cytokines like granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells from the marrow followed by their injection into the hepatic artery or portal vein after purification. The latter is probably more cumbersome and may be potentially risky due to the underlying coagulation abnormalities in cirrhotic patients .

G-CSF has been shown to mobilise bone marrow stem cells and even increase survival in patients of severe alcoholic steatohepatitis and ACLF. There is conflicting evidence on the role of G-CSF in decompensated cirrhosis with some studies showing improved survival while others have shown a lack of clinical or biochemical benefit. Many of these studies have used a single course of G-CSF. Verma et al, in a recent study published in 2018, elegantly demonstrated the beneficial effect of multiple courses of G-CSF in improving mortality and transplant free survival in decompensated cirrhotics.

The investigators too speculate that multiple cycles of G-CSF could result in better outcomes in decompensated cirrhosis by causing more prolonged and sustained stem cell homing to the liver. Thus, this study is being undertaken to further evaluate the safety and efficacy of multiple cycles of G-CSF in decompensated cirrhotics.


Options:
A: Arm Label: Standard Medical therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: standard medical therapy | Arm Label: G-CSF; Type: EXPERIMENTAL; Interventions: Drug: standard medical therapy, Drug: G-CSF | Arm Label: G-CSF and NAC; Type: EXPERIMENTAL; Interventions: Drug: standard medical therapy, Drug: G-CSF, Drug: n-Acetylcysteine | Intervention Type: DRUG; Name: standard medical therapy; Assigned to Arm(s): G-CSF, G-CSF and NAC, Standard Medical therapy | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): G-CSF, G-CSF and NAC | Intervention Type: DRUG; Name: n-Acetylcysteine; Assigned to Arm(s): G-CSF and NAC
B: Arm Label: G-CSF + Standard therapy; Type: EXPERIMENTAL; Interventions: Drug: G-CSF, Other: Standard therapy | Arm Label: Standard therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard therapy | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): G-CSF + Standard therapy | Intervention Type: OTHER; Name: Standard therapy; Assigned to Arm(s): G-CSF + Standard therapy, Standard therapy
C: Arm Label: Standard Medical Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard Medical Therapy | Arm Label: G-CSF + Standard Medical Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: G-CSF, Drug: Standard Medical Therapy | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): G-CSF + Standard Medical Therapy | Intervention Type: DRUG; Name: Standard Medical Therapy; Assigned to Arm(s): G-CSF + Standard Medical Therapy, Standard Medical Therapy
D: Arm Label: G-CSF+EPO; Type: ACTIVE_COMPARATOR; Interventions: Drug: G-CSF+EPO | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: G-CSF+EPO; Assigned to Arm(s): G-CSF+EPO | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C