Hepatoma ResectableEarly Phase 1NCT05035108
The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
A Early Phase 1 study testing hiHep bioartificial liver therapy in people with Hepatoma Resectable, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hepatoma Resectable
- What is being tested?
- hiHep bioartificial liver therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2021to 30 Nov 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
Who cannot join
- 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;
- Uncontrolled infection;
- The platelet count is less than 50,000/μL and cannot be corrected;
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- There is no blood vessel available for dialysis treatment;
- HIV, HDV or HCV positive;
- Drug abuse within 1 year;
- 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.;
- Combined pregnancy;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Xiujun Cai, MD, 0086-0571-86006605, caixiujunzju@yahoo.com.cn
Hanning Ying, MS, 0086-0571-86006276, henry_yinghn@163.com
About this study
Official title: A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy
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.
Read the detailed description
Include large-scale hepatectomy patients who meet the Inclusion criteria into the experimental group. Patient will be sent to ICU monitoring after surgery , the investigators will evaluate the blood routine, liver and kidney function, blood coagulation function, and immune inflammation indicators on the first day after surgery, and large veins will be temporarily indwelled within 48-72 hours Hemodialysis tube, then take artificial liver treatment which lasts 4-6h, follow-up test results on the 1st day, 3rd day, 7th day, 1 month and 3 months about blood routine, liver and kidney function, coagulation function, blood ammonia, Immune inflammation indicators, imaging examinations (CT or MR) at 7 days, 1 month and 3 months after treatment, to evaluate the recovery of liver function and liver regeneration after artificial liver treatment.
- Conditions
- Hepatoma Resectable
- Being tested
- hiHep bioartificial liver therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hiHep bioartificial liver therapyBiological
HiHep cell bioartificial liver treatment was performed 48-72 hours after extensive hepatectomy. Temporary hemodialysis tube for large vein (jugular vein or femoral vein) is indwelled before treatment. Before treatment, prepare hiHeps-BAL in a biological safety cabinet that meets clinical standards, connect the corresponding tubing to the Jianfan DX-10 blood purification machine, and prefill with heparin saline. Half an hour before treatment, the patient was pre-heparinized (heparin about 600iu) and dexamethasone to prevent allergic reactions. The patient enters the ICU, the monitor is connected to the corresponding pipeline, the arterial pump 120-160ml/min, the slurry pump 30-40ml/min, the circulating pump 75-100ml/min, the duration is 4-6h.
| Study group | Role | What they receive |
|---|---|---|
| extensive hepatectomy patient | Experimental | hiHep bioartificial liver therapy Receives: Biological: hiHep bioartificial liver therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (safety and tolerability).
Record adverse events (AE), serious adverse events (SAE), and AEs (TEAE) that occurred during treatment.
Measured: 3 months after therapy
Secondary outcomes (7)
Patient's recovery of liver function
Through child-pugh liver function grading standard and changes in ALT, AST, AKP, r-GGT, TBil, DBil, ALB to evaluate liver function.
Measured: 1day,3day,7day,1month,3 months after therapy
Rate of liver proliferation
Remaining liver growth rate (calculation of residual liver volume based on CT three-dimensional reconstruction).
Measured: 7day,1month,3 months after therapy
Incidence of liver failure
Use Guidelines for The Diagnosis and Treatment of Liver Failure (exclude liver failure caused by surgical hemodynamic problems).
Measured: 1day,3day,7day,1month,3 months after therapy
Complication rate
Such as pleural effusion, hydrops abdominis, hemorrhage, bile leakage.
Measured: 1day,3day,7day,1month,3 months after therapy
Immunoinflammatory index
Changes in PCT, hCRP, immune globulin (IgA, IgM, IgG), complement (C3, C4) after the treatment.
Measured: 1day,3day,7day,1month,3 months after therapy
Renal function
Record the changes in creatinine and urea nitrogen, calculate GFR through MDRD or CKD-EPI formula to evaluate renal function by classification standards for renal insufficiency.
Measured: 1day,3day,7day,1month,3 months after therapy
Electrolyte level
Changes in the concentration of Na+, K+, Cl+, Ca+ in blood before and after treatment.
Measured: 1day,3day,7day,1month,3 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Sep 2021
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatoma ResectableStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hexaell Biotech Co., Ltd.
- Responsible party
- Principal investigator, Xiujun Cai, Sir Run Run Shaw Hospital
- Investigators
- Yifan Wang, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035108
- Sponsor's protocol ID
- SRRSH20201110-8
- Status last verified
- Jun 2025
- First submitted
- 31 May 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy
- ClinicalTrials.gov ID
- NCT05035108
- Acronym / sponsor ID
- SRRSH20201110-8
- Conditions
- Hepatoma Resectable
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Hexaell Biotech Co., Ltd.
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Include large-scale hepatectomy patients who meet the Inclusion criteria into the experimental group. Patient will be sent to ICU monitoring after surgery , the investigators will evaluate the blood routine, liver and kidney function, blood coagulation function, and immune inflammation indicators on the first day after surgery, and large veins will be temporarily indwelled within 48-72 hours Hemodialysis tube, then take artificial liver treatment which lasts 4-6h, follow-up test results on the 1st day, 3rd day, 7th day, 1 month and 3 months about blood routine, liver and kidney function, coagulation function, blood ammonia, Immune inflammation indicators, imaging examinations (CT or MR) at 7 days, 1 month and 3 months after treatment, to evaluate the recovery of liver function and liver regeneration after artificial liver treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extensive hepatectomy patient | Experimental | Biological: hiHep bioartificial liver therapyhiHep bioartificial liver therapy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%;
Key exclusion criteria (16 listed)
- 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;
- Uncontrolled infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hiHep bioartificial liver therapyHiHep cell bioartificial liver treatment was performed 48-72 hours after extensive hepatectomy. Temporary hemodialysis tube for large vein (jugular vein or femoral vein) is indwelled before treatment. Before treatment, prepare hiHeps-BAL in a biological safety cabinet that meets clinical standards, connect the corresponding tubing to the Jianfan DX-10 blood purification machine, and prefill with heparin saline. Half an hour before treatment, the patient was pre-heparinized (heparin about 600iu) and dexamethasone to prevent allergic reactions. The patient enters the ICU, the monitor is connected to the corresponding pipeline, the arterial pump 120-160ml/min, the slurry pump 30-40ml/min, the circulating pump 75-100ml/min, the duration is 4-6h. | Biological | extensive hepatectomy patient |
Primary outcome
The incidence of adverse events (safety and tolerability).
Time frame: 3 months after therapy
Record adverse events (AE), serious adverse events (SAE), and AEs (TEAE) that occurred during treatment.
7 secondary outcomes
Patient's recovery of liver function
Time frame: 1day,3day,7day,1month,3 months after therapy
Rate of liver proliferation
Time frame: 7day,1month,3 months after therapy
Incidence of liver failure
Time frame: 1day,3day,7day,1month,3 months after therapy
Complication rate
Time frame: 1day,3day,7day,1month,3 months after therapy
Immunoinflammatory index
Time frame: 1day,3day,7day,1month,3 months after therapy
Renal function
Time frame: 1day,3day,7day,1month,3 months after therapy
Electrolyte level
Time frame: 1day,3day,7day,1month,3 months after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yifan Wang, MD principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hiHep bioartificial liver therapy in people with Hepatoma Resectable, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiujun Cai, MD (0086-0571-86006605, caixiujunzju@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (safety and tolerability). (time frame: 3 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.