A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy

Who is this study for? Patients with Resectable Hepatoma
What treatments are being studied? hiHep Bioartificial Liver Therapy
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• 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%;

Locations
Other Locations
China
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Xiujun Cai, MD
caixiujunzju@yahoo.com.cn
0086-0571-86006605
Time Frame
Start Date: 2021-09-05
Estimated Completion Date: 2030-11-30
Participants
Target number of participants: 10
Treatments
Experimental: extensive hepatectomy patient
hiHep bioartificial liver therapy
Related Therapeutic Areas
Sponsors
Leads: Sir Run Run Shaw Hospital
Collaborators: Hexaell Biotech Co., Ltd.

This content was sourced from clinicaltrials.gov