Using stem cells from umbilical cords to treat severe liver disease

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Decompensated Cirrhosis Patients(MSC-DLC-2)

This study is testing whether stem cells from umbilical cords can help people with severe liver disease feel better and avoid the need for a liver transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing 302 Hospital (Academic / other)
• Locations: 7 sites (Lanzhou, Gansu and 6 other locations)
• Trial ID: NCT05224960 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of mesenchymal stem cells (MSCs) derived from umbilical cords in treating patients with decompensated cirrhosis. The study aims to provide an alternative to liver transplantation, which is limited by donor availability and complications. Participants will receive either the MSC treatment or a placebo, and their liver function will be monitored throughout the trial. The research builds on previous findings that suggest MSC therapy can improve liver function and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 diagnosed with decompensated liver cirrhosis and a MELD score between 15 and 30.

Not a fit: Patients with active variceal bleeding, severe infections, or those with specific types of hepatitis-related cirrhosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, less invasive option for patients with decompensated cirrhosis, potentially improving their liver function and quality of life.

How similar studies have performed: Other studies using MSCs for liver diseases have shown varying degrees of success, indicating potential but also the need for further investigation.

Eligibility criteria

Inclusion Criteria:

1. Willing to provide written informed consent;
2. Aged 18 to 75 years (including 18 and 75 years), male or female;
3. Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications);
4. The Model for End-stage Liver Disease (MELD) score 15 to 30 points.

Exclusion Criteria:

1. Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit.
2. Uncontrolled severe infection within 2 weeks of screening.
3. Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months, or hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.
4. Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HCV for less than 12 months, or hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening (except HCV RNA\< detection limit without any antiviral treatment).
5. Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
6. Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
7. Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.
8. Significant renal insufficiency (serum creatinine ≥ 1.2 times upper normal limit); Severe electrolyte abnormality (serum sodium level \< 125 mmol/L); Severe leukopenia (white blood cell count \< 1 × 10E9/L).
9. Patients with biliary obstruction, or portal vein spongiosis.
10. Patients with surgical history such as splenic cut-off flow.
11. Patients with malignant tumors within 5 years, except those with basal cell carcinoma, squamous cell carcinoma and/or carcinoma in situ who had received curative treatment and curative resection.
12. Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems.
13. Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
14. Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive.
15. Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test.
16. Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients.
17. History of pulmonary embolism.
18. Patients who had previously received stem cell therapy or were intolerant to cell therapy.
19. The proposed line of liver transplants within three months.
20. Participants in other clinical trials within the last 3 months.
21. Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.

Where this trial is running

Lanzhou, Gansu and 6 other locations

• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Third Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Hainan hospital of Chinese PLA General Hospital — Sanya, Hainan, China (Recruiting)
• Jin Yin-tan Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Xinjiang Kashi Area Number 1 Hospital — Kashgar, Xinjiang, China (Not_yet_recruiting)
• Beijing 302 Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Lei Shi, MD,PhD

Conditions Decompensated Cirrhosis