Acute-On-Chronic Liver FailurePhase 2/3MSCTACLFNCT06884904
Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF
A Phase 2/3 study testing Low-dose experimental group and High-dose experimental group in people with Acute-On-Chronic Liver Failure, run by National Engineering Center of Cell Products.
Trial 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, focusing on patients with acute-on-chronic liver failure (ACLF). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- Low-dose experimental group and High-dose experimental group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 14 Apr 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Umbilical Mesenchymal Stem Cells in the Treatment of Acute-on-Chronic Liver Failure：A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIb/III Seamless Adaptive Design Clinical Study
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, focusing on patients with acute-on-chronic liver failure (ACLF). Eligible patients meeting the inclusion criteria and not disqualified were randomized in a 2:2:1:1 ratio during Phase IIb to receive either a high-dose experimental group (4.0×10^6/kg of injectable mesenchymal stem cells derived from umbilical cord), a low-dose group (2.0×10^6/kg), a high-dose placebo control group (with equivalent volume of solvent calculated at 4.0×10^6/kg), or a low-dose placebo control group (with equivalent volume of solvent calculated at 2.0×10^6/kg). In Phase III, patients were randomized in a 1:1 ratio to the experimental group (injectable umbilical cord-derived mesenchymal stem cells) or the control group. All groups received standard treatment alongside either the experimental drug (experimental group) or placebo (control group) to evaluate and confirm the efficacy and safety of injectable umbilical cord-derived mesenchymal stem cells in treating acute-on-chronic liver failure.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- Low-dose experimental group, High-dose experimental group, Low-dose placebo control group, High-dose placebo control group
- Keywords
- acute-on-chronic liver failure, mesenchymal stem cells
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose experimental groupDrug
2.0*10^6/kg
High-dose experimental groupDrug
4.0*10^6/kg
Low-dose placebo control groupDrug
Equivalent volume of solvent calculated at 2.0×10^6/kg
High-dose placebo control groupDrug
Equivalent volume of solvent calculated at 4.0×10^6/kg
| Study group | Role | What they receive |
|---|---|---|
| Low-dose experimental group | Experimental | 2.0×10^6/kg Receives: Drug: Low-dose experimental group |
| High-dose experimental group | Experimental | 4.0×10^6/kg Receives: Drug: High-dose experimental group |
| Low-dose placebo control group | Placebo comparator | Equivalent volume of solvent calculated at 2.0×10^6/kg Receives: Drug: Low-dose placebo control group |
| High-dose placebo control group | Placebo comparator | Equivalent volume of solvent calculated at 4.0×10^6/kg Receives: Drug: High-dose placebo control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
90 day mortality rate (D90) of subjects randomly assigned and receiving the investigational drug
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion14 Apr 2027 (estimated)
- Study completion14 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Engineering Center of Cell Products
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884904
- Sponsor's protocol ID
- MSCTACLF-02
- Acronym
- MSCTACLF
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Mesenchymal Stem Cells in the Treatment of Acute-on-Chronic Liver Failure：A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIb/III Seamless Adaptive Design Clinical Study
- ClinicalTrials.gov ID
- NCT06884904
- Acronym / sponsor ID
- MSCTACLF / MSCTACLF-02
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- acute-on-chronic liver failure, mesenchymal stem cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- National Engineering Center of Cell ProductsUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, focusing on patients with acute-on-chronic liver failure (ACLF). Eligible patients meeting the inclusion criteria and not disqualified were randomized in a 2:2:1:1 ratio during Phase IIb to receive either a high-dose experimental group (4.0×10^6/kg of injectable mesenchymal stem cells derived from umbilical cord), a low-dose group (2.0×10^6/kg), a high-dose placebo control group (with equivalent volume of solvent calculated at 4.0×10^6/kg), or a low-dose placebo control group (with equivalent volume of solvent calculated at 2.0×10^6/kg). In Phase III, patients were randomized in a 1:1 ratio to the experimental group (injectable umbilical cord-derived mesenchymal stem cells) or the control group. All groups received standard treatment alongside either the experimental drug (experimental group) or placebo (control group) to evaluate and confirm the efficacy and safety of injectable umbilical cord-derived mesenchymal stem cells in treating acute-on-chronic liver failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose experimental group | Experimental | Drug: Low-dose experimental group2.0×10^6/kg |
| High-dose experimental group | Experimental | Drug: High-dose experimental group4.0×10^6/kg |
| Low-dose placebo control group | Placebo comparator | Drug: Low-dose placebo control groupEquivalent volume of solvent calculated at 2.0×10^6/kg |
| High-dose placebo control group | Placebo comparator | Drug: High-dose placebo control groupEquivalent volume of solvent calculated at 4.0×10^6/kg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose experimental group2.0*10^6/kg | Drug | Low-dose experimental group |
| High-dose experimental group4.0*10^6/kg | Drug | High-dose experimental group |
| Low-dose placebo control groupEquivalent volume of solvent calculated at 2.0×10^6/kg | Drug | Low-dose placebo control group |
| High-dose placebo control groupEquivalent volume of solvent calculated at 4.0×10^6/kg | Drug | High-dose placebo control group |
Primary outcome
mortality rate
Time frame: 90 day
90 day mortality rate (D90) of subjects randomly assigned and receiving the investigational drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acute-On-Chronic Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low-dose experimental group and High-dose experimental group in people with Acute-On-Chronic Liver Failure, run by National Engineering Center of Cell Products.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhibo Han (+86-02266211430, hanzhibo@amcellgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.