Status:
NOT_YET_RECRUITING
Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF
Lead Sponsor:
National Engineering Center of Cell Products
Conditions:
Acute-On-Chronic Liver Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a multicenter, randomized, double-blind, placebo-controlled adaptive design Phase IIb/III clinical trial. It employs a seamless adaptive design, divided into Phase IIb and Phase III, foc...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Patients with hepatitis B virus (HBV)-associated acute-on-chronic liver failure (ACLF) meeting the following criteria: Total bilirubin (TBil) ≥12 mg/dL (equivalent to 205 μmol/L); International normalized ratio (INR) ≥1.5 or prothrombin activity (PTA) ≤40%;
- All participants and their partners agree to use effective non-pharmacological contraception during the trial and for 6 months after trial completion, with no plans for conception during this period.
- Voluntarily participate in the clinical study and sign the informed consent form.
Exclusion
- History of allergy to any component of the investigational drug or bovine-derived products.
- Acute, subacute, or chronic liver failure unrelated to HBV, or ACLF caused by: Concurrent hepatitis A, C, or E virus infection; Autoimmune liver disease; Biliary obstruction.
- Presence of any of the following complications: \<1\> Active gastrointestinal bleeding (e.g., hematemesis and/or melena) or high- risk esophageal/gastric varices (confirmed by endoscopy or imaging within 3 months prior to screening). \<2\> Imaging evidence (ultrasound or CT) of cavernous transformation of the portal vein or portal vein occlusion. \<3\> History of transjugular intrahepatic portosystemic shunt (TIPS). \<4\> Grade 3 or 4 hepatic encephalopathy. \<5\> Serum creatinine ≥2 mg/dL. \<6\> Respiratory insufficiency (e.g., dyspnea, cyanosis) with peripheral oxygen saturation ≤93% at rest.
- Severe underlying diseases, including: \<1\>Septic shock (requiring vasopressors to maintain mean arterial pressure ≥65 mmHg despite adequate fluid resuscitation, with blood lactate \>2 mmol/L). \<2\> Uncontrolled cardiac conditions: Myocardial ischemia or infarction (CTCAE v5.0 Grade ≥II), Arrhythmias requiring intervention, NYHA Class III-IV heart failure. \<3\> Active malignancy (solid or hematologic). \<4\> Diagnosed pulmonary hypertension or suspected pulmonary embolism. \<5\> IgA deficiency, Henoch-Schönlein purpura, hemophilia, or idiopathic thrombocytopenia. \<6\> Immunodeficiency disorders (e.g., HIV infection, congenital/acquired immune deficiency).
- Current systemic corticosteroid therapy for other diseases.
- Psychiatric or other conditions deemed by the investigator to interfere with study assessments.
- Planned or active registration for liver transplantation, or anticipated transplantation within 3 months.
- History of liver transplantation.
- Alcohol or substance abuse: Chronic alcohol use (\>5 years with ethanol intake ≥40 g/day for males or ≥20 g/day for females), Heavy alcohol use (\>80 g/day ethanol) within 2 weeks prior to screening, Abstinence \<6 months.
- Participation in another clinical trial within 3 months prior to screening (excluding screen failures or withdrawal before dosing).
- Pregnancy, lactation, or positive pregnancy test at screening.
- Any other condition that, in the investigator's judgment, may confound study results, pose risks, or compromise the participant's best interests.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 14 2028
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06884904
Start Date
April 15 2025
End Date
April 14 2028
Last Update
March 19 2025
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