Transplanting stem cells from umbilical cords to treat liver failure

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

This study is testing if transplanting stem cells from umbilical cords can help people with severe liver failure feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing 302 Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05985863 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 who meet the criteria for acute-on-chronic liver failure.

Not a fit: Patients with acute kidney injury, severe hepatic encephalopathy, or those with liver cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve clinical outcomes and survival rates for patients suffering from acute-on-chronic liver failure.

How similar studies have performed: Other studies have explored mesenchymal stem cell therapies for liver diseases, showing promising results, but this specific approach is still being evaluated.

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.

Where this trial is running

Beijing, Beijing Municipality

• 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

Conditions Acute-On-Chronic Liver Failure; Mesenchymal Stem Cells; Therapeutics