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New treatment option for Decompensated Hepatitis B Cirrhosis
Official title Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis
ClinicalTrials.gov ID: NCT07413549
What this study is testing
What is Human Umbilical Cord Mesenchymal Stem Cells Injection?
Human Umbilical Cord Mesenchymal Stem Cells Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for decompensated hepatitis b 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
- Phase I (Single Administration, Randomized, Double-blind, Dose Escalation)Primary Objective: To evaluate the safety and tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, and to determine the safe clinical dose.Secondary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, providing a basis for the design of subsequent clinical trial protocols.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Phase II (Multiple Administrations, Randomized, Double-blind, Dose Expansion)Primary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Secondary Objective: To evaluate the safety of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Aged between 18 and 75 years (inclusive) at screening, regardless of gender.
- Diagnosed with decompensated hepatitis B cirrhosis with a history of portal hypertension-related complications according to the Guidelines for the...
- After at least 3 months of strict conservative medical treatment (including antiviral therapy with nucleos(t)ide analogues, hepatoprotective...
- HBV DNA level \< 2 × 10³ IU/mL at screening.
- Not suitable for liver transplantation, or lacking a liver donor source.
You likely can't join if
- Cirrhosis due to other causes, such as alcoholic hepatitis, hepatitis C virus infection, autoimmune hepatitis, and metabolic dysfunction-associated...
- Child-Pugh score \> 12 points.
- History of malignancy in the liver or other organs, or a family history of liver malignancy in first-degree relatives.
- The investigator judges that the subject currently has severe internal medical diseases that would affect the safety and how well it works evaluation...
- Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically...
- Occurrence of hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening.
See the full eligibility criteria
- Aged between 18 and 75 years (inclusive) at screening, regardless of gender.
- Diagnosed with decompensated hepatitis B cirrhosis with a history of portal hypertension-related complications according to the Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 Edition).
- After at least 3 months of strict conservative medical treatment (including antiviral therapy with nucleos(t)ide analogues, hepatoprotective, symptomatic, and nutritional support therapy), there has been no significant...
- HBV DNA level \< 2 × 10³ IU/mL at screening.
- Not suitable for liver transplantation, or lacking a liver donor source.
- Both the subject and their partner have no plans for pregnancy from screening until 6 months after the end of the trial and agree to use effective non-pharmacological contraception during the trial period.
- Fully understand the informed consent form, voluntarily participate in the trial, and sign the informed consent form.
- Cirrhosis due to other causes, such as alcoholic hepatitis, hepatitis C virus infection, autoimmune hepatitis, and metabolic dysfunction-associated steatotic liver disease (MASLD).
- Child-Pugh score \> 12 points.
- History of malignancy in the liver or other organs, or a family history of liver malignancy in first-degree relatives.
- The investigator judges that the subject currently has severe internal medical diseases that would affect the safety and how well it works evaluation of the treatment, such as: cardiovascular diseases including cardiac...
- Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically significant major upper gastrointestinal bleeding event within 4 weeks...
- Occurrence of hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening.
- Presence of spontaneous bacterial peritonitis or severe active infection within 2 weeks prior to screening.
- Positive results in infectious disease serology (positive for serum anti-HIV antibody, anti-HCV antibody, or syphilis antibody) or patients with active tuberculosis.
- Use of human albumin within 3 weeks prior to the first infusion of the investigational product.
- History of venous thrombosis or pulmonary embolism, deemed unsuitable for the trial by the investigator.
- Drug addiction or alcohol abuse.
- Pregnant or lactating women.
- Allergy to any component of the umbilical cord mesenchymal stem cells or excipients, or history of severe drug allergy or allergic constitution.
- History of severe psychiatric disorders within 24 months prior to screening, including uncontrolled severe depression or controlled/uncontrolled psychosis.
- Participation in other treatment clinical trials within 3 months prior to screening or currently, or previous receipt of stem cell therapy.
- Planned liver transplantation within 3 months after screening.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, 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 Wuhan, China. 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.