NCT05035108 The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
| NCT ID | NCT05035108 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Sir Run Run Shaw Hospital |
| Condition | Hepatoma Resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2021-09-05 |
| Primary Completion | 2030-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2021-09-05 with a primary completion date of 2030-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is a prospective, non-randomized, single-arm cohort study. A total of 10 patients will be included in this study. Based on standardized treatment, the treatment of bioartificial liver device will be applied 48-72 hours after extensive hepatectomy. The bioartificial liver device consists of clinical-grade human-induced hepatocytes (hiHep) generated from human fibroblasts via transdifferentiation. In order to evaluate the security and effectiveness of the device, liver function, liver volume, the incidence of liver failure and other results will be analyzed.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection; 2. Liver function Child A-B; 3. There is no contraindication to surgery for cardiopulmonary function; 4. The expected remaining liver volume/standard liver volume is less than 50%; Exclusion Criteria: 1. In the late stage of the disease, patients with frequent symptoms such as cerebral edema accompanied by cerebral herniation and clinical evidence indicating intracranial hemorrhage; 2. PaO2/FiO2 is less than 200 and cannot be corrected; 3. Patients with diffuse intravascular coagulation; 4. Those with active bleeding; 5. Uncontrolled infection; 6. The platelet count is less than 50,000/μL and cannot be corrected; 7. There is no blood vessel available for dialysis treatment; 8. HIV, HDV or HCV positive; 9. Drug abuse within 1 year; 10. Those with severe systemic circulatory failure; 11. Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.; 12. Combined pregnancy; 13. Patients with hepatorenal syndrome; 14. Patients with autoimmune liver disease; 15. Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency); 16. Other conditions that the clinician believes cannot tolerate the treatment.
Contact & Investigator
Yifan Wang, MD
PRINCIPAL INVESTIGATOR
Sir Run Run Shaw Hospital
Frequently Asked Questions
Who can join the NCT05035108 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Hepatoma Resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05035108 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05035108 currently recruiting?
Yes, NCT05035108 is actively recruiting participants. Contact the research team at caixiujunzju@yahoo.com.cn for enrollment information.
Where is the NCT05035108 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05035108 clinical trial?
NCT05035108 is sponsored by Sir Run Run Shaw Hospital. The principal investigator is Yifan Wang, MD at Sir Run Run Shaw Hospital. The trial plans to enroll 10 participants.