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Clinical Trial NCT07409259 for Acute-on-Chronic Liver Failure (ACLF) is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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PT-MSCs Exosome Injection in the Treatment of Chronic-to-acute Liver Failure Early Phase 1 20 Randomized
Clinical Trial NCT07409259 is designed to study Treatment for Acute-on-Chronic Liver Failure (ACLF). It is a Early Phase 1 interventional study that is active, not recruiting, having started on 1 January 2026, with plans to enroll 20 participants. Led by Third Affiliated Hospital, Sun Yat-Sen University, it is expected to complete by 31 August 2027. The latest data from ClinicalTrials.gov was last updated on 13 February 2026.
Brief Summary
The goal of this single-center, prospective, randomized controlled study is to evaluate the safety and efficacy of PT-MSCs Exosome Injection (code: PT-MSCs-EVS-2023-1) in treating patients with acute-on-chronic liver failure (ACLF). As an exploratory study with a small sample size, the primary focus is to observe safety outcomes and preliminary efficacy. The study will enroll patients aged 18 to 65 years who meet the...Show More
Official Title
Single-center, Prospective, Randomized Controlled Study of PT-MSCs Exosome Injection (Code: PT-MSCs-EVS-2023-1) in the Treatment of Chronic-to-acute Liver Failure
Conditions
Acute-on-Chronic Liver Failure (ACLF)Other Study IDs
- PL21
NCT ID Number
Start Date (Actual)
2026-01-01
Last Update Posted
2026-02-13
Completion Date (Estimated)
2027-08-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Early Phase 1
Status
Active, not recruiting
Keywords
Acute -On-Chronic Liver Failure
Bio-artificial liver
Exosome
Mesenchymal stem cells
Bio-artificial liver
Exosome
Mesenchymal stem cells
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorControl Group Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. Artificial liver support or liver transplantation may be performed based on the investigator's clinical judgment. | standard comprehensive internal medical treatment, Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. |
ExperimentalStudy Group In addition to the standard treatment received by the control group, participants will receive PT-MSCs Exosomes (2×10\^11 particles per dose). | exosome injection For the Study Group, the exosome injection is diluted in 100 mL of normal saline and administered via intravenous infusion over a period of not less than 2 hours. Treatment is administered once every 3 days (on Day 1, Day 4, Day 7, and Day 10) for a total of 4 doses. standard comprehensive internal medical treatment, Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
12-Week Survival Rate | The percentage of participants who are alive at 12 weeks after enrollment. | 12 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes from the baseline in COSSH-ACLF II score | The Chinese Severe Hepatitis B Study Group (COSSH), based on a multicenter, open-label large cohort study, has established a novel prognostic scoring system for hepatitis B virus (HBV)-ACLF: COSSH-ACLF II s. The COSSH-ACLF II score is calculated as: 1.649×ln(INR) + 0.457×HE grade + 0.425×ln(neutrophils) + 0.396×ln(TBil) + 0.576×ln(urea) + 0.033×age. Theoretically, the score ranges from \~1.0 to \~15.0, though clinically observed values typically fall between 4.5 and 10.0. A score of less than 7.4 indicates a low-risk group, a score between 7.4 and 8.4 indicates a moderate-risk group, and a score greater than 8.4 indicates a high risk of 28- and 90-day mortality.Higher scores indicate greater severity of liver failure and a worse outcome. | 12 weeks |
Changes from the baseline in Child-Pugh score | The Child-Pugh Score assesses the prognosis of chronic liver disease based on five indicators: hepatic encephalopathy, ascites, total bilirubin, albumin, and PT/INR. The total score ranges from 5 to 15. Higher scores indicate worse liver function. (Classification: Grade A = 5-6 points; Grade B = 7-9 points; Grade C = 10-15 points.) | 12-weeks |
Change from Baseline in Clinical Symptom Score | Assessment of clinical symptoms including fatigue, anorexia, nausea, jaundice, and level of consciousness. Each symptom is graded on a scale from 0 (absent) to 3(severe). The individual scores are summed to calculate a total symptom score ranging from 0 to 15. Higher scores indicate more severe symptoms. | 12 weeks |
4-Week Survival Rate | The percentage of participants who are alive at 4 weeks after enrollment | 4 weeks |
The rate of participants with adverse outcomes at Week 4 and Week 12 | The rate of adverse outcomes, defined as death, treatment abandonment, or liver transplantation. | 4-week , 12-week |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Aged 18 to 65 years, regardless of gender.
- Diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to the diagnostic criteria in the "Guidelines for Diagnosis and Treatment of Liver Failure (2024 Edition)."
- COSSH-ACLF II score < 7.4.
- Participants must be fully informed about the study and voluntarily sign a written informed consent form prior to participation.
- Patients with chronic liver failure.
- Patients with active bleeding or Disseminated Intravascular Coagulation (DIC) that has not been effectively controlled.
- Known allergy to blood products or any medications/drugs used in the treatment protocol.
- Patients with circulatory failure.
- History of myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months.
- History of malignancy within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Pregnant or lactating women.
- Any other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in the trial.
Third Affiliated Hospital, Sun Yat-Sen UniversityStudy Responsible Party
Liang Peng, Principal Investigator, Professor, Third Affiliated Hospital, Sun Yat-Sen University
No contact data.
1 Study Locations in 1 Countries
Guangdong
Third Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China 510630, Guangzhou, Guangdong, 510630, China