A Phase 1/2 interventional study of standard medical treatment and Placebo in Acute-On-Chronic Liver Failure, sponsored by Beijing 302 Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Beijing 302 Hospital · Phase 1/2, Interventional, and Treatment
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Among 48 studies in Acute-On-Chronic Liver Failure with a site in China — 18 open to participants now, 22 under way, none of them phase 3. Acute-On-Chronic Liver Failure · China.
Among the 48 studies in Acute-On-Chronic Liver Failure with a site in China, this one is the 6th largest by planned enrollment of the 25 interventional ones that give a count, is one of 12 that started in 2023, is one of 4 in phase 1/2, reaches primary completion later than 16 of the 21 other live ones, and was the 33rd registered.
167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.
Browse Acute-On-Chronic Liver Failure studies →18 of the 48 studies in Acute-On-Chronic Liver Failure with a site in China are open now. Recruiting first, the newest first:
Shenzhen Third People's Hospital · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18+
Third Affiliated Hospital, Sun Yat-Sen University · Sites in China
Ages 18–70
RenJi Hospital · Sites in China
Ages 18–65
Nanfang Hospital, Southern Medical University · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 32 Acute-On-Chronic Liver Failure studies recruiting now, 11 (34%) set no upper age limit and 15 (47%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 8 · Phase 4 1
First in 2007; this study’s year is marked. 12 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 73 across 96 interventional studies indexed under Acute-On-Chronic Liver Failure.
Median enrollment 80 across the 25 interventional studies, 411 across the 23 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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3 of 48 have an industry lead sponsor. The 10 most frequent:
Beijing 302 Hospital is the lead sponsor of 88 studies on the registry; 31 are open to participants now.
Beijing 302 Hospital has 2 studies filed under Acute-On-Chronic Liver Failure — fewer than ten, so there is no comparison to draw.
5 of the studies in Acute-On-Chronic Liver Failure with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05985863Beijing 302 HospitalHuman Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure | 2026-12-30 |
| NCT06996392Third Affiliated Hospital, Sun Yat-Sen UniversityPhase I Trial of QH-1A Hybrid Bio-Artificial Liver With Ex Vivo Blood-Purifying MSCs in Acute-on-Chronic Liver Failure | 2026-12-31 |
| NCT07409259Third Affiliated Hospital, Sun Yat-Sen UniversityPT-MSCs Exosome Injection in the Treatment of Chronic-to-acute Liver Failure | 2027-08-31 |
| NCT06562803Third Affiliated Hospital, Sun Yat-Sen UniversityEfficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis | 2027-10-31 |
| NCT06916585Shenzhen Third People's HospitalChinese Phase II Trail of AS1501 in Acute-on-chronic Liver Failure (ACLF) Patients | 2027-11-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 48 studies in Acute-On-Chronic Liver Failure with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.
Acute-on-chronic liver failure (ACLF) has been proposed to define a distinct syndrome which is characterized by an intense systemic inflammatory response, single- or multiple organ system failures, and high 28-day mortality. Current treatments for liver failure are still limited, and liver transplantation remains the only available approach to improve survival but is restricted by a shortage of organ resources, rejection after transplantation, and heavy financial costs. In the past decade, a series of new applications based on mesenchymal stem cell (MSC) therapy have been studied as an alternative interventional method for chronic liver diseases. This randomized double-blind placebo-controlled multicenter clinical trial is aimed at determining the safety and clinical efficacy of UC-MSC transfusions in ACLF patients.
A total of 150 ACLF patients would be enrolled,100patients would be assigned to the MSC intervention group and the other 50 patients would be assigned to the placebo control group. This trial is two-stage randomized designed. At the first stage, the patients would be randomized into two groups, the placebo short control group would receive standard medical treatment plus 3 times placebo (at week0, week1 and week2), while the MSC short treatment group would receive standard medical treatment plus 3 times hUC-MSC (1.5×10\^8, Peripheral IV, at week0, week1 and week2). The two groups would be followed up for 2 weeks, and unblinding would be conducted at week4. At the second stage, the survived patients of the MSC short treatment group would be further randomized and blinded into another two groups. The MSC Prolonged treatment group would receive another 2 times hUC-MSC (1.5×10\^8, Peripheral IV, at week4 and week5), while the MSC Prolonged control group would receive 2 times placebo (at week4 and week5).
Transplantation free survival rate and incidence of treatment-emergent adverse events would be the primary outcomes, and other outcomes such as international normalized ratio (INR), total bilirubin (TBIL, mg/dL), serum albumin (ALB, g/L), blood urea nitrogen (BUN, mmol/l), the model for end-stage liver disease(MELD) score and child-turcotte-pugh(CTP) score would also be measured.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard medical treatment+Placebo(5% human serum albumin in 0.9% saline, at week0, week1 and week2)
Drug: standard medical treatment · Drug: Placebo
Patients received standard medical treatment and infusions of hUC-MSC(1.5×10\^8) via peripheral veins once a week for 3 timess(at week0, week1, and week2).
Drug: standard medical treatment · Drug: hUC-MSC
Patients in Group MSC-1 received standard medical treatment and infusions of hUC-MSC(1.5×10\^8) via peripheral veins once a week for another 2 timess(at week4 and week5).
Drug: standard medical treatment · Drug: hUC-MSC · Drug: hUC-MSC_Prolonged
standard medical treatment for ACLF
5% human serum albumin in 0.9% saline (at week0, week1 and week2)
hUC-MSC (1.5×10\^8 cells/time, Peripheral IV, at week0, week1 and week2)
hUC-MSC (1.5×10\^8 cells/time, Peripheral IV, at week4 and week5)
Transplantation free survival rate
Transplantation free survival rate of ACLF patients.
Time frame: week1, week2, week3, week4, week5, week8, week12, week24, week53
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability of UC-MSCs transplantation.
Time frame: day0, day3, week1, week2, week3, week4, week5, week8, week12, week24, week53
International Normalized Ratio (INR)
INR was introduced as a standardized reporting mechanism allowing comparisons across laboratories and patients. Consensus guidelines recommend that INR ≥ 1.5 can be used as a threshold, and current recommendations for targeting an INR of \< 1.5 were based on studies across all surgical disciplines.
Time frame: week-1, week0, day3, week1, week2, week3, week4, week5, week12, week24, week53
Concentration of Total Bilirubin (TBIL, mg/dL)
Total bilirubin refers to the concentration of bilirubin in a patient's blood sample, which is automatically measured by the laboratories in accordance with standard operating procedures. APASL defines ACLF as "an acute hepatic insult manifesting as jaundice (Serum Bilirubin ≥ 5 mg/dL) and coagulopathy (international normalized ratio \[INR\] ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, that is associated with a high 28-day mortality."
Time frame: week-1, week0, day3, week1, week2, week3, week4, week5, week12, week24, week53
Concentration of Serum Albumin (ALB, g/L)
Serum albumin refers to the concentration of albumin in a patient's serum, which is automatically measured by the laboratory in accordance with standard operating procedures. Serum albumin is an independent protective factor for 30-day prognosis in ACLF patients.
Time frame: week-1, week0, day3, week1, week2, week3, week4, week5, week12, week24, week53
Concentration of Blood Urea Nitrogen (BUN, mmol/L)
Blood urea nitrogen refers to the concentration of urea nitrogen in a patient's blood sample. Blood urea nitrogen is a commonly used indicator of renal function in clinic.
Time frame: week-1, week0, day3, week1, week2, week3, week4, week5, week12, week24, week53
The Model for End-Stage Liver Disease(MELD) score
R = 3.8×ln \[TBiL (mg/dl)\] +11.2×ln (INR) +9.6×ln \[Cr (mg/dl)\] +6.4× (Cause: biliary or alcoholic is 0, other is 1), the result is taken as an integer. Studies have shown that the optimal critical value of MELD score to judge the short-term prognosis of ACLF patients is 30, and when MELD score is greater than 30, the case fatality rate of patients within 3 months is significantly increased.
Time frame: week-1, week1, week2, week4, week5, week12, week24, week53
Child-Turcotte-Pugh(CTP) score
CTP score is currently the most commonly used model to evaluate liver reserve function and prognosis in patients with cirrhosis. This model evaluates liver function based on HE grade, degree of abdominal fluid accumulation, bilirubin (TBiL), albumin (Alb) and prothrombin time (PT). The score ranges from 0 to 15, with the higher the score, the worse the prognosis.
Time frame: week-1, week1, week2, week4, week5, week12, week24, week53
Plan to share: No
Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 months after the start.
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Studies of the drug tested here: Solizmestrocel
Acute-On-Chronic Liver Failure →
Beijing 302 Hospital