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New treatment option for Acute-On-Chronic Liver Failure
Official title Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure
ClinicalTrials.gov ID: NCT05985863
What this study is testing
What is standard medical treatment?
standard medical treatment is an investigational medicine, given as an infusion into a vein, 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 study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 70
You may be able to join if
- 18 years old ≤ age ≤ 70 years old, gender is not limited.
- Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis...
- Willing to sign the informed consent form.
You likely can't join if
- Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at...
- Before the onset of liver failure, the previous indicators of the patient included PLT\ 9;
- Combined with liver cancer or other malignant tumors;
- Patients with previous liver transplantation or planned liver transplantation within 3 months;
- Severe organic disease of primary extrahepatic organs;
- Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;
See the full eligibility criteria
- 18 years old ≤ age ≤ 70 years old, gender is not limited.
- Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg/dl or more) and...
- Willing to sign the informed consent form.
- Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;
- Before the onset of liver failure, the previous indicators of the patient included PLT\ 9;
- Combined with liver cancer or other malignant tumors;
- Patients with previous liver transplantation or planned liver transplantation within 3 months;
- Severe organic disease of primary extrahepatic organs;
- Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;
- Pregnant, breastfeeding women or those who plan to have a baby in the near future;
- Those who are highly allergic or have a history of severe allergies;
- Those who have received immunosuppressant and immune enhancer treatment within 1 month;
- Drug abuse in the past 5 years;
- Alcohol withdrawal symptoms;
- A history of severe mental disorders within 24 months before screening, including uncontrolled major depression or controlled or uncontrolled psychosis;
- Those who have participated or are participating in other clinical trials within three months before screening, or have previously received stem cell therapy;
- Other conditions that the investigator thinks that the patient is not suitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.