Actively Recruiting
The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
Led by Sir Run Run Shaw Hospital · Updated on 2025-06-26
10
Participants Needed
1
Research Sites
481 weeks
Total Duration
On this page
Sponsors
S
Sir Run Run Shaw Hospital
Lead Sponsor
H
Hexaell Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with liver cancer, hepatolithiasis, or benign liver tumor with clear need for liver surgery
- Liver function classified as Child A or Child B
- No contraindications for surgery based on heart and lung function
- Expected remaining liver volume is less than 50% of standard liver volume
You will not qualify if you...
- Late-stage disease with symptoms like cerebral edema or intracranial hemorrhage
- PaO2/FiO2 less than 200 and not correctable
- Diffuse intravascular coagulation
- Active bleeding
- Uncontrolled infection
- Platelet count below 50,000/µL and not correctable
- No blood vessel available for dialysis
- Positive for HIV, HDV, or HCV
- Drug abuse within the past year
- Severe systemic circulatory failure
- High allergy to treatment drugs such as plasma, heparin, or protamine
- Pregnancy
- Hepatorenal syndrome
- Autoimmune liver disease
- Non-alcoholic fatty liver disease or hereditary liver diseases like Wilson syndrome or alpha-antitrypsin deficiency
- Other conditions making treatment intolerable as judged by clinician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiujun Cai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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