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A Clinical Research on the Safety of Hepatocytes Therapy Generated from Human Embryonic Stem Cells for Patients with Acute or Acute-on-Chronic Liver Failure

A Clinical Research on the Safety of Hepatocytes Therapy Generated from Human Embryonic Stem Cells for Patients with Acute or Acute-on-Chronic Liver Failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052988
Enrollment
Unknown
Registered
2021-11-07
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute or Acute-on-Chronic Liver Failure

Interventions

HPLC group 1:peripheral intravenous injection
HPLC group 2:intraperitoneal injection

Sponsors

Xiangya Hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, no gender restrictions, body mass index (BMI) between 18-35 kg/m^2, including boundary values; 2. According to clinical symptoms, signs and laboratory tests, meet the diagnostic criteria for acute or acute-on-chronic liver failure in the Chinese Guidelines for the Diagnosis and Treatment of Liver Failure (2018 Edition), and the MELD index is between 20-40. 3. Have not received cell preparation therapy in the last 6 months.

Exclusion criteria

Exclusion criteria: 1. End-stage liver disease with serious complications, including but not limited to grade IV hepatic encephalopathy, severe gastrointestinal bleeding, severe bleeding tendency, refractory ascites, hepatorenal syndrome reaching AKI stage 3, Hepatopulmonary syndrome, etc; 2. Combine serious infections that cannot be controlled 3. There are other important organ diseases, such as uncontrolled severe cardiovascular diseases (such as ventricular tachycardia, arrhythmia caused by second or third degree atrioventricular block, myocardial infarction, unstable angina, coronary Arterial disease, heart failure, etc.), uncontrolled hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg), severe respiratory diseases (active tuberculosis, chronic obstructive pulmonary disease, pulmonary interstitial disease, etc.) , Severe blood system diseases (such as myelodysplastic syndrome, thalassemia, aplastic anemia, etc.), cerebral hemorrhage, etc. 4. Have a history of severe allergic reaction or allergies to 2 or more than 2 kinds of food or drugs; 5. Serum HIV antibody positive; 6. Diagnosis of primary liver cancer or presence of liver nodules with unknown nature 7. Presence of other systemic malignancies 8. Patients with severe mental illness and cognitive dysfunction 9. Women who are pregnant, breast-feeding or planning to become pregnant 10. Participated in other clinical studies within the last 3 months; 11. Inability or unwillingness to provide informed consent; 12. The researchers believe that there are patients who cannot be included in this study for other reasons.

Design outcomes

Primary

MeasureTime frame
Liver function;Blood coagulation function;MELD score;Liver color Doppler ultrasound;Blood routine;Urine routine;Blood chemistry;Tumor markers;Electrocardiogram;CT of lung and liver ;

Countries

China

Contacts

Public ContactHuang Yan

Xiangya Hospital Central South University

drhyan@163.com+86 13874854142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 24, 2026