RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
Spain30 participantsStarted 2024-10-15
Plain-language summary
The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and anti-fibrotic effect, will be given to humans.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female age ≥18-75 years.
✓. Patient confirms willingness/ability to comply with all study procedures.
✓. Diagnosis of liver cirrhosis based on at least one of:
✓. Clinical and radiological features that correlate with a diagnosis of cirrhosis.
✓. Transient elastography (Fibroscan) \>15 kPa.
✓. Previous liver biopsy confirming histological features of cirrhosis.
✓. Aetiology of liver disease of steatotic liver disease including MASLD or Met-ALD or ALD
✓. Hospitalised as an inpatient for a recent major hepatic decompensation event including ascites, hepatic encephalopathy, variceal bleed, HRS-AKI or SBP, this being the only hospitalisation for an hepatic decompensation event hospitalisation within the last 6 months, and where recent is defined as within 6 weeks of hospital discharge.
Exclusion criteria
✕. Liver cirrhosis due to:
✕. any viral hepatitidies, or
✕. autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.
✕. Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.
What they're measuring
1
Safety and Tolerability
Timeframe: 2.5 years
2
Safety and Tolerability
Timeframe: At each infusion; day of infusion up to two weeks post-infusion
✕. Any current organ failure requiring more than outpatient supportive care, and not associated with the participant's qualifying hepatic decompensation event.
✕. Known splenomegaly ≥16 cm.
✕. Thrombocytopenia \<50×109/L.
✕. Presence or suspicion of any of the following co-morbidities: