Liver CirrhosisPhase 1NCT04806581
Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis
A Phase 1 study testing Allogeneic Hepatocyte in people with Liver Cirrhosis, run by RenJi Hospital at 1 site in China.
Trial summary
The Primary Objective: To observe and determine the safety and tolerance of allogeneic hepatocyte transplantation in patients with liver cirrhosis and to establish the maximum-tolerated dose (MTD) and evaluate the dose-limiting toxicities (DLTs). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Allogeneic Hepatocyte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age at the time of signing the informed consent from 18 to 70 years old (including the boundary value), both male and female;
- Clinical diagnosis of liver cirrhosis;
- Be able to understand and sign informed consent.
Who cannot join
- Combined with liver cancer or other malignant tumors;
- Patients who can't cooperate;
- Prothrombin time (PT) exceeded the upper limit of normal control for 3-5 seconds or more;
- International normalized ratio (INR) >1.5;
- PLT<60×109/L；
- Recently use of anticoagulant or antiplatelet drugs (last 7 days);
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- Recently (last 4 weeks) had upper gastrointestinal bleeding or spontaneous celiac inflammation;
- Moderate or large amount of ascites;
- The investigator assesses that the patient is unable or unwilling to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
About this study
Official title: Clinical Study of Congener Allogeneic Hepatocyte Transplantation Treatment in Patients With Liver Cirrhosis
The Primary Objective: To observe and determine the safety and tolerance of allogeneic hepatocyte transplantation in patients with liver cirrhosis and to establish the maximum-tolerated dose (MTD) and evaluate the dose-limiting toxicities (DLTs).
The Secondary Objective: To observe the therapeutic efficacy of allogeneic hepatocyte transplantation for liver cirrhosis.
Read the detailed description
- A traditional 3 + 3 dose escalation design will be implemented.
- Successive cohorts of participants (3 or 3+3 participants /cohort) will start on a fixed cell numbers of allogeneic hepatocyte in three cohorts separately: L dose (low cell numbers); M dose (medium cell numbers); H dose (high cell numbers).
- The 1st cohort will be given dose of L.
- The 2nd cohort will be given dose of M.
- The 3rd cohort will be given dose of H.
- Dose escalation will continue until the maximum-tolerated dose (MTD). If no DLTs are observed for 28days after administration of the last dose, a new cohort will be enrolled at the next planned dose level. If DLTs are observed in 2 of the three participants, the MTD will be determined to be the dose administered to the previous cohort. If DLTs are observed in one participant in the cohort, another three participants will be treated with the same dose level. If the new three participants aren't observed DLTs, another cohort will be enrolled at the upper dose. If at least one of the new three ones are observed DLTs, the below dose will be the MTD.
- MTD will stopped by testing increasing up to the H dose.
- Toxicities will be graded using the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0).
- Conditions
- Liver Cirrhosis
- Being tested
- Allogeneic Hepatocyte
- Keywords
- Liver cirrhosis; allogeneic hepatocyte; transplantation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic HepatocyteDrug
Allogeneic hepatocyte with cell numbers L,M,H respectively.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Hepatocyte Cohort 1 | Experimental | Participants will each be administered L dose for one time. With 28days follow-up after the cells infusion.
Allogeneic hepatocyte cell numbers: L Receives: Drug: Allogeneic Hepatocyte |
| Allogeneic Hepatocyte Cohort 2 | Experimental | Participants will each be administered M dose for one time. With 28days follow-up after the cells infusion.
Allogeneic hepatocyte cell numbers: M Receives: Drug: Allogeneic Hepatocyte |
| Allogeneic Hepatocyte Cohort 3 | Experimental | Participants will each be administered H dose for one time. With 28days follow-up after the cells infusion.
Allogeneic hepatocyte cell numbers: H Receives: Drug: Allogeneic Hepatocyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Observe the safety and tolerance after single infusion of hepatocyte.
Measured: 28days
Dose-Limiting Toxicities
Observe the safety and tolerance after single infusion of hepatocyte.
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start20 Apr 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Xia, Doctor, Principal investigator, Department of Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806581
- Sponsor's protocol ID
- HI-IM-001
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 19 Mar 2021
- 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 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Congener Allogeneic Hepatocyte Transplantation Treatment in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04806581
- Acronym / sponsor ID
- HI-IM-001
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis; allogeneic hepatocyte; transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 19 Mar 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.
The Primary Objective: To observe and determine the safety and tolerance of allogeneic hepatocyte transplantation in patients with liver cirrhosis and to establish the maximum-tolerated dose (MTD) and evaluate the dose-limiting toxicities (DLTs).
The Secondary Objective: To observe the therapeutic efficacy of allogeneic hepatocyte transplantation for liver cirrhosis.
Detailed description
- A traditional 3 + 3 dose escalation design will be implemented.
- Successive cohorts of participants (3 or 3+3 participants /cohort) will start on a fixed cell numbers of allogeneic hepatocyte in three cohorts separately: L dose (low cell numbers); M dose (medium cell numbers); H dose (high cell numbers).
- The 1st cohort will be given dose of L.
- The 2nd cohort will be given dose of M.
- The 3rd cohort will be given dose of H.
- Dose escalation will continue until the maximum-tolerated dose (MTD). If no DLTs are observed for 28days after administration of the last dose, a new cohort will be enrolled at the next planned dose level. If DLTs are observed in 2 of the three participants, the MTD will be determined to be the dose administered to the previous cohort. If DLTs are observed in one participant in the cohort, another three participants will be treated with the same dose level. If the new three participants aren't observed DLTs, another cohort will be enrolled at the upper dose. If at least one of the new three ones are observed DLTs, the below dose will be the MTD.
- MTD will stopped by testing increasing up to the H dose.
- Toxicities will be graded using the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Hepatocyte Cohort 1 | Experimental | Drug: Allogeneic HepatocyteParticipants will each be administered L dose for one time. With 28days follow-up after the cells infusion. Allogeneic hepatocyte cell numbers: L |
| Allogeneic Hepatocyte Cohort 2 | Experimental | Drug: Allogeneic HepatocyteParticipants will each be administered M dose for one time. With 28days follow-up after the cells infusion. Allogeneic hepatocyte cell numbers: M |
| Allogeneic Hepatocyte Cohort 3 | Experimental | Drug: Allogeneic HepatocyteParticipants will each be administered H dose for one time. With 28days follow-up after the cells infusion. Allogeneic hepatocyte cell numbers: H |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The age at the time of signing the informed consent from 18 to 70 years old (including the boundary value), both male and female;
- Clinical diagnosis of liver cirrhosis;
- Be able to understand and sign informed consent.
Key exclusion criteria (9 listed)
- Combined with liver cancer or other malignant tumors;
- Patients who can't cooperate;
- Prothrombin time (PT) exceeded the upper limit of normal control for 3-5 seconds or more;
- International normalized ratio (INR) >1.5;
- PLT<60×109/L；
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 |
|---|---|---|
| Allogeneic HepatocyteAllogeneic hepatocyte with cell numbers L,M,H respectively. | Drug | Allogeneic Hepatocyte Cohort 1, Allogeneic Hepatocyte Cohort 2, Allogeneic Hepatocyte Cohort 3 |
Primary outcome
Maximum Tolerated Dose
Time frame: 28days
Observe the safety and tolerance after single infusion of hepatocyte.
Dose-Limiting Toxicities
Time frame: 28days
Observe the safety and tolerance after single infusion of hepatocyte.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- 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. This study is not recruiting at the moment.
Qiang Xia, Doctor principal investigator
Department of Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic Hepatocyte in people with Liver Cirrhosis, run by RenJi 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Xia, Doctor (0086-02168383134, xiaqiang@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 28days). The study lists 2 primary outcomes in all. 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 19 Mar 2021.