A Phase 2 interventional study of HepaStem in Acute-On-Chronic Liver Failure, sponsored by Cellaion SA. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Cellaion SA · Phase 2, Interventional, and Treatment
The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.
This study's enrollment of 24 is below the median of 72 across 95 interventional studies indexed under Acute-On-Chronic Liver Failure.
Browse Acute-On-Chronic Liver Failure studies →Cellaion SA is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two dose regimens of HepaStem will be given, which differ in the amount of cells per infusion. The low dose regimen will be given to the first cohort (first 6 patients included in the study).
Biological: HepaStem
The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach)
Biological: HepaStem
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
Time frame: up to 28Day post first infusion day
Efficacy assessed by clinical parameters
Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.
Time frame: 28Day, 3 month and 1 year post first infusion day
Efficacy assessed by biological parameters
Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values
Time frame: 28Day, 3 month and 1 year post first infusion day
Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest
Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal
Time frame: 3 month and 1 year post first infusion day
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Acute-On-Chronic Liver Failure →
Cellaion SA