Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure

Launched by BEIJING 302 HOSPITAL · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with acute-on-chronic liver failure (ACLF), which is a serious condition where the liver suddenly worsens in someone who already has liver problems. The researchers want to see if using stem cells from human umbilical cords can help improve health outcomes for these patients. This study is carefully designed, meaning that neither the participants nor the researchers will know who is receiving the actual treatment and who is receiving a placebo (a harmless treatment that looks the same). This helps to ensure the results are reliable.

To participate in this trial, you need to be between 18 and 70 years old and have been diagnosed with ACLF. Some common signs of ACLF include jaundice (yellowing of the skin and eyes) and problems with blood clotting. Participants who join the study will receive the treatment or placebo and will be monitored closely by medical staff. It’s important to note that not everyone can participate; for example, individuals with severe kidney problems, active infections, or certain types of cancer are excluded. If you or someone you know is dealing with ACLF and is interested in this study, it could be a chance to help test a potential new treatment while receiving expert medical care.

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Eligibility criteria

• 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.