NCT05035108RecruitingEarly phase 1
The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy
Source: ClinicalTrials.gov · Last updated 26 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 31 May 2021
- Start date
- 5 Sept 2021
- Primary completion date
- 30 Nov 2030
- Lead sponsor
- Sir Run Run Shaw Hospital
- NCT number
- NCT05035108
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 5 Sept 2021 to the primary completion date, 30 Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug abuse within 1 year;
Other illness
- 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;
- Those with active bleeding;
- Uncontrolled infection;
- HIV, HDV or HCV positive;
- Those with severe systemic circulatory failure;
- Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.;
- Patients with hepatorenal syndrome;
- Patients with autoimmune liver disease;
- Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency);
- Other conditions that the clinician believes cannot tolerate the treatment.
Lab values
- The platelet count is less than 50,000/μL and cannot be corrected;
Other
- PaO2/FiO2 is less than 200 and cannot be corrected;
- Patients with diffuse intravascular coagulation;
- There is no blood vessel available for dialysis treatment;
- Combined pregnancy;
Who the study is looking for
- Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;
- Liver function Child A-B;
- There is no contraindication to surgery for cardiopulmonary function;
- The expected remaining liver volume/standard liver volume is less than 50%;
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.