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New treatment option for Acute-On-Chronic Liver Failure
Official title Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults
ClinicalTrials.gov ID: NCT05727722
What this study is testing
What is a single course of micro-encapsulated hepatocytes intraperitoneal transplantation therapy?
a single course of micro-encapsulated hepatocytes intraperitoneal transplantation therapy is an investigational medicine, being studied as a potential treatment for acute-on-chronic liver failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective single-center dose escalation study of the administration of the microencapsulated hepatocyte therapy in adult liver failure. The purpose of the study is to determine the maximum tolerated dose of microencapsulated hepatocytes in liver failure patients and its effectiveness in treating the disease.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- A. Chronic liver failure (CLF) group: The progressive liver function decline or decompensation after liver cirrhosis:
- Body weight\>40kg;
- Aged between 18 to 65 years old;
- Serum Total bilirubin was higher than the normal range and lower than 10 times the upper limit of normal value (ULN);
- With or without significantly decreased serum albumin value, lower than 35;
You likely can't join if
- With obvious brain edema, cerebral hernia, or indicated intracranial hemorrhage;
- Diagnosed or suspected as primary or metastatic liver cancer;
- With uncorrectable oxygenation index (PaO2/FiO2)\<200;
- With disseminated intravascular coagulation;
- Active hemorrhage;
- Uncontrollable infection, including ascites infection such as spontaneous bacterial peritonitis;
See the full eligibility criteria
- A. Chronic liver failure (CLF) group: The progressive liver function decline or decompensation after liver cirrhosis:
- Body weight\>40kg;
- Aged between 18 to 65 years old;
- Serum Total bilirubin was higher than the normal range and lower than 10 times the upper limit of normal value (ULN);
- With or without significantly decreased serum albumin value, lower than 35;
- With or without significantly decreased platelet (PLT) value, prothrombin activity (PTA)≤40% (or international normalized ratio (INR)≥1.5), other reasons excluded;
- With or without refractory ascites or portal hypertension;
- With or without a stage I or II hepatic encephalopathy;
- No obvious improvement after more than 3 days' regular clinical treatments. OR B. Acute-on-chronic liver failure (ACLF) group: With known or unknown basic liver diseases, people undergoing acute liver failure syndrome...
- Body weight\>40kg;
- Aged between 18 to 65 years old;
- With obvious fatigue, accompanied by other gastrointestinal symptoms such as anorexia, vomiting, and abdominal distension;
- Complicated with ascites and/or hepatic encephalopathy within 4 weeks after being diagnosed;
- Progressive aggravation of jaundice, total serum bilirubin≥85umol/L；
- Coagulation disorders, INR\>1.5 or PTA\<40%;
- No obvious improvement after more than 3 days' regular clinical treatments.
- With obvious brain edema, cerebral hernia, or indicated intracranial hemorrhage;
- Diagnosed or suspected as primary or metastatic liver cancer;
- With uncorrectable oxygenation index (PaO2/FiO2)\<200;
- With disseminated intravascular coagulation;
- Active hemorrhage;
- Uncontrollable infection, including ascites infection such as spontaneous bacterial peritonitis;
- Uncorrectable decrease in PLT (\<20×109/L);
- HIV and/or SARS-CoV-Ⅱ positive;
- Drug abuse within 1 year;
- Systemic hemodynamic instability;
- Combined with pregnancy or lactation;
- Other situations excluded by clinician;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.