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New treatment option for Decompensated Cirrhosis
Official title Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
ClinicalTrials.gov ID: NCT05224960
What this study is testing
What is UC-MSCs?
UC-MSCs is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for decompensated cirrhosis.
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
- Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions.
- 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 75
You may be able to join if
- Willing to provide written informed consent;
- Aged 18 to 75 years (including 18 and 75 years), male or female;
- Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative...
- The Model for End-stage Liver Disease (MELD) score 15 to 30 points.
You likely can't join if
- Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to...
- Uncontrolled severe infection within 2 weeks of screening.
- Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral...
- Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral...
- Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
- Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
See the full eligibility criteria
- Willing to provide written informed consent;
- Aged 18 to 75 years (including 18 and 75 years), male or female;
- 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...
- The Model for End-stage Liver Disease (MELD) score 15 to 30 points.
- Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit.
- Uncontrolled severe infection within 2 weeks of screening.
- 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)...
- 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)...
- Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
- Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
- Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.
- 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).
- Patients with biliary obstruction, or portal vein spongiosis.
- Patients with surgical history such as splenic cut-off flow.
- 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.
- Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems.
- Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
- Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive.
- Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test.
- Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients.
- History of pulmonary embolism.
- Patients who had previously received stem cell therapy or were intolerant to cell therapy.
- The proposed line of liver transplants within three months.
- Participants in other clinical trials within the last 3 months.
- Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Sanya, Hainan, China
- Wuhan, Hubei, China
- Shanghai, Shanghai Municipality, China
- Kashgar, Xinjiang, China
- Beijing, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Sanya, Hainan, China; Wuhan, Hubei, China; Shanghai, Shanghai Municipality, China; Kashgar, Xinjiang, China and 1 more location(s). 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.