Study in Patients with Decompensated Liver Cirrhosis

Individuals eligible to participate in this study must meet the following criteria:

Inclusion Criteria:

1. Male or female age ≥18-75 years.

2. Patient is willing and able to provide informed consent to participate in the study.

3. Patient confirms willingness/ability to comply with all study procedures.

4. Has a diagnosis of liver cirrhosis determined by a physician based on at least oneof the following:

5. clinical and radiological features that correlate with a diagnosis ofcirrhosis;

6. transient elastography (TE) (FibroscanTM) >15kPa;

7. previous liver biopsy confirming histological features of cirrhosis.

9. For eligibility at Screen Part 2 - Aetiology of liver disease of steatoticliver disease (SLD) including pure metabolic dysfunction associated steatoticliver disease (MASLD) or metabolic and alcohol related/associated liver disease (Met-ALD), or alcohol-related liver diseases (ALD). a. Patients with ALD or Met-ALD only if they are confirmed to not be drinkingalcohol above Met-ALD limits defined in this protocol AND have phosphatidyl ethanol (PEth) test <200 ng/ml. (N.B. No more than 34% of the total patients in thisprotocol will be ALD [excludes Met-ALD]).

10. Meets one of the following criteria:

11. a. Hospitalised as an in-patient for a recent major hepatic decompensationevent (qualifying event) including ascites, HE or variceal bleed, HRS-AKI orSBP, this being the only hospitalisation for an hepatic decompensation eventwithin the last 6 months, and where recent is defined as within 6 weeks ofhospital discharge OR

12. Out-patient: Medically refractory ascites is defined by the repeated (≥ 2) needfor LVP (i.e., therapeutic, not diagnostic) at least once per 8 weeks despitebest medical attempts to control the ascites by sodium restriction and diuretictreatment, as confirmed by the Investigator, with date on of onset [defined asthe date of the second therapeutic paracentesis] occurring within the past 6months.

13. MELD 3.0 score of 12-20 taken within 2 weeks of qualifying event.

14. Has stabilised post-hepatic decompensation event, as defined by two MELD assessments (within 1 point of each) other taken within 2 weeks, or physician assessed asstable. with the ability to safely cell mobilise with GCSF, apherese and receivedRTX001 treat in the interventional Phase 1/2 study.

Exclusion Criteria:

1. Liver cirrhosis due to:

2. any viral hepatitis , or

3. autoimmune and cholestatic aetiologies including, but not limited to, primarybiliary cholangitis and primary sclerosing cholangitis.

4. Acute liver disease in the absence of underlying liver cirrhosis, including, but notlimited to, drug induced liver injury.

5. Any current organ failure requiring more than out-patient non-invasive supportivecare, and not associated with the patient's qualifying hepatic decompensation event.

6. Known splenomegaly ≥16cm.

7. Thrombocytopenia <50,000 mm3.

8. Sepsis (with positive microbial cultures) or as defined by the Investigator, unlessstable and is at least 4 weeks after having completed a full course of intravenousantibiotics.

9. Presence or suspicion of any of the following co-morbidities:

10. a. history of liver transplantation or other organ transplant;

11. ACLF;

12. known human immunodeficiency virus;

13. pulmonary embolism;

14. hepatocellular carcinoma, or active malignant disease within the last 5 years, (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficialbladder cancer, benign polyps etc.);

15. co-hepatic morbidities e.g., portal vein thrombosis;

16. hepatic hydrothorax unless it is a small hydrothorax, not clinically apparent,that is detected incidentally by radiologic evaluation that does not requireclinical intervention.

17. chronic renal impairment (on dialysis) or unresolved acute kidney injury;

18. acute or chronic heart failure (New York Heart Association Grade III/IV);

19. porto-pulmonary hypertension;

20. severe chronic lung disease e.g., chronic obstructive pulmonary disease orinterstitial lung disease where the forced expiratory volume (FEV1) is lessthan 50% and/or FEV1/forced vital capacity is less than 60%;

21. hepatopulmonary syndrome;

22. history or current treatment with chronic albumin treatment;

23. significant untreated/unstable psychiatric disease;

24. transjugular intrahepatic portosystemic shunt (TIPSS) within the previous 6months.

25. Current or planned use of immunosuppressive medication, with the exception of lowdoses up to 10 mg/day prednisone or equivalent, or inhaled steroids to manage anasthma, which are permitted.

26. Any other intercurrent illness that is either life-threatening or of clinicalsignificance such that it might limit compliance with study procedures, in theInvestigator's opinion.

27. Current alcohol misuse defined as alcohol intake greater than 3 units/day forfemales and 4 units/day for males, or binge drinking (>14 units/day) as determinedby the Investigator or PEth alcohol test >200 ng/ml. One alcohol unit is equivalentto14 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25mL) measure of spirits. Note: patients with history of exceeding these alcohol uselimits, if meeting all other inclusion/exclusion criteria, are limited to 34% ofenrolled patients.

28. Intake of non-medically supervised drugs of abuse that is judged (by theInvestigator) to be a high risk to the patient's acute health or which makes thepatient likely to be non-compliant with follow-up.

29. Are currently participating in an investigational interventional study. Note:concurrent participation in another non-interventional study is permitted.