The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
ConditionHepatoma Resectable
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age30-80
SponsorSir Run Run Shaw Hospital
About this trial
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
Qualifiers
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%;
Disqualifiers
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;
PaO2/FiO2 is less than 200 and cannot be corrected;
Patients with diffuse intravascular coagulation;
Those with active bleeding;
Trial design
Treatments tested in this trial
- hiHep bioartificial liver therapy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Sir Run Run Shaw Hospital
Lead sponsor
Hexaell Biotech Co., Ltd.
Collaborator
Source ClinicalTrials.gov