Transplanting stem cells from umbilical cords to treat liver failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation in patients with acute-on-chronic liver failure (ACLF). It is a randomized double-blind placebo-controlled multicenter trial involving 150 participants, where 100 will receive UC-MSC therapy and 50 will receive a placebo. The study aims to provide scientific evidence for UC-MSC as a potential treatment option for ACLF, which currently has limited treatment alternatives. Participants will be monitored for clinical outcomes over a period of four weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years old ≤ age ≤ 70 years old, gender is not limited.
2. 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 coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%） complicated within 4 weeks by clinical ascites, encephalopathy, or both.
3. Willing to sign the informed consent form.

Exclusion Criteria:

1. Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;
2. Before the onset of liver failure, the previous indicators of the patient included PLT\<50×10\^9/L or Child-Pugh score\>9;
3. Combined with liver cancer or other malignant tumors;
4. Patients with previous liver transplantation or planned liver transplantation within 3 months;
5. Severe organic disease of primary extrahepatic organs;
6. Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;
7. Pregnant, breastfeeding women or those who plan to have a baby in the near future;
8. Those who are highly allergic or have a history of severe allergies;
9. Those who have received immunosuppressant and immune enhancer treatment within 1 month;
10. Drug abuse in the past 5 years;
11. Alcohol withdrawal symptoms;
12. A history of severe mental disorders within 24 months before screening, including uncontrolled major depression or controlled or uncontrolled psychosis;
13. Those who have participated or are participating in other clinical trials within three months before screening, or have previously received stem cell therapy;
14. Other conditions that the investigator thinks that the patient is not suitable to participate in this study.

Where it's running

• the Fifth Medical Center, Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Ming Shi, PhD — the Fifth Medical Center, Chinese PLA General Hospital
• Study coordinator: Tao Yang, MD
• Email: y_t_0321@163.com
• Phone: 86-010-66933333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors that affect how well mesenchymal stromal cell (MSC) therapy works for hepatitis B–related acute-on-chronic liver failure.

  This project will look back at people with hepatitis B–related ACLF who received MSC infusions to see which factors affect whether the treatment helps.

  Recruiting Sun Yat-sen University · Guangzhou, Guangdong · NCT07198854

• AS1501 in ACLF: a two-stage dose study in adults with acute-on-chronic liver failure

  This Phase II study tests AS1501 given by injection in adults with early ACLF to see if it’s safe and tolerable and to guide dosing.

  Recruiting Phase 2 Shenzhen Third People's Hospital · Shenzhen, Guangdong · NCT06916585

• TAK-242 and G-CSF in ACLF: a new treatment approach for adults with acute-on-chronic liver failure

  This trial tests whether adding TAK-242, with or without G-CSF, to standard ACLF care helps patients with severe alcoholic hepatitis and ACLF.

  Recruiting Phase 2 Yaqrit Ltd · London, Greater London · NCT06890039

• Using different ROTEM cut-offs to guide blood transfusions before procedures in cirrhosis and ACLF

  This will test whether using relaxed ROTEM cut-offs to decide on blood transfusions reduces the number of transfusions without raising bleeding risk for people with cirrhosis or ACLF and severe coagulopathy who need invasive procedures.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi, National Capital Territory of Delhi · NCT06831565

• Ceftazidime-avibactam vs high-dose meropenem for ACLF patients with hospital-acquired infections

  This trial tests whether ceftazidime-avibactam can better treat infections in ACLF patients than high-dose meropenem given in extended infusions, aiming to spare carbapenems if possible.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi, National Capital Territory of Delhi · NCT06818565

• Evaluating a new treatment for liver failure and sepsis

  This study is testing a new treatment for people with liver failure and sepsis to see if it can help them survive and improve their organ function.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT06562803

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.