Decompensated CirrhosisPhase 1/2HCL001NCT07488546

HCL001 Cell Injection for Decompensated Cirrhosis: A Phase I/II Trial

A Phase 1/2 study testing Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg) and Cohort 3 (4.0 × 10⁶ cells/kg) in people with Decompensated Cirrhosis, run by Shanghai Huicun Medical Technology Co., Ltd. at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Decompensated Cirrhosis
What is being tested?: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg) and Cohort 3 (4.0 × 10⁶ cells/kg)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteChina
Study dates: 23 Sep 2025to 30 Dec 2028
Phase: Phase 1/2

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years at the time of informed consent; sex unrestricted.
Diagnosis of decompensated cirrhosis established according to the Chinese Guidelines for the Diagnosis and Treatment of Liver Cirrhosis (2019 Edition) and attributable to: hepatitis B, hepatitis C, alcohol, autoimmune disease, metabolic-associated fatty liver disease, or other less common aetiologies when deemed appropriate by the investigator.
Karnofsky Performance Status (KPS) ≥ 60 (see Appendix 6).
Presence of a vascular access route judged safe for selective catheterisation of the proper hepatic artery.
For subjects with hepatitis B or C cirrhosis: HBV-DNA ≤ 50 IU/mL and HCV-RNA below the limit of quantification at screening; for alcohol-related cirrhosis: documented abstinence for ≥ 6 months.
Ability to understand the study procedures and willingness to comply; written informed consent obtained from the subject or legally authorised representative.

Who cannot join

Known hypersensitivity to HCL001 Cell Injection or any of its excipients.
Child-Pugh score ≥ 13 (see Appendix 1 for scoring and classification).
Cavernous transformation of the portal vein.
Serum total bilirubin > 10 × the upper limit of normal (ULN).
Hepatocellular carcinoma or any other concurrent malignancy.
Inability to cooperate or unwillingness to comply with protocol requirements.

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Bleeding diathesis (e.g., haemophilia) or platelet count < 40 × 10⁹/L despite platelet-raising therapy.
Use of anticoagulant or antiplatelet agents within 7 days prior to dosing.
Grade ≥ 3 hepatic encephalopathy within 3 months before dosing (grading criteria in Appendix 2).
Previous transjugular intrahepatic portosystemic shunt (TIPS) or requirement/planned TIPS during the study.
History of venous thrombosis, including portal vein thrombosis (PVT) Grade ≥ 2 (grading criteria in Appendix 9), deemed unsuitable by the investigator.
Severe dysfunction of vital organs (heart, lung, brain, kidney):
Pulmonary: severe emphysema, pulmonary embolism, or any pulmonary disorder significantly impairing pulmonary function.
Cardiac history meeting any of the following:
Decompensated heart failure (NYHA Class III-IV);
Unstable angina within 6 months before dosing. Chronic kidney disease (CKD) Stage 4-5.
Inadequately controlled diabetes despite treatment: HbA1c ≥ 8 % or fasting plasma glucose ≥ 10 mmol/L.
Pregnancy or lactation women; or inability/unwillingness to use Investigator-approved contraceptive methods during the study and for 6 months after study completion.
Participation in another interventional clinical trial within 3 months before screening, or prior receipt of any stem-cell therapy.
Positive human immunodeficiency virus (HIV) antibody.
Active infection (defined as an infection, other than intra-abdominal, requiring intravenous antibiotics) within 2 weeks before screening, deemed unsuitable by the investigator.
Ascites with concurrent intra-abdominal infection [defined as: 1. Positive ascitic fluid culture; or 2. Ascitic polymorphonuclear neutrophil (PMN) count ≥ 250 × 10⁶/L], deemed by the Investigator as unsuitable for trial participation.
History of drug abuse or psychiatric disorders.
Any other condition or circumstance-including concomitant disease, therapy, procedure, surgery, or clinically significant laboratory abnormality-that, in the opinion of the investigator, could interfere with study conduct, impose additional risk to the subject, or preclude safe participation or completion of the study.

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

Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospita
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection in Patients With Decompensated Cirrhosis

Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited.

Upon completion of the Week 12 assessment in the last subject enrolled in Phase I, one or two dose levels will be selected for Phase II expansion based on the safety and preliminary efficacy data obtained during Phase I.

Read the detailed description

A single SRC will be convened during the Phase I dose-escalation stage to conduct dynamic safety oversight. The SRC will comprise investigators, the Sponsor, and/or medically qualified personnel designated by the Sponsor's delegate (contract research organization [CRO]). Detailed SRC procedures are provided in a separate SRC charter.

Begin with three subjects in the lowest cohort.
If zero of three subjects experience a DLT during the observation period, escalate to the next cohort.
If one of three subjects experiences a DLT, enroll an additional three subjects at the same dose level.
If ≤ 1/6 total subjects in the expanded cohort experience a DLT, escalate to the next cohort.
If > 1/6 experience a DLT, dose escalation is terminated.
If ≥ 2 of the initial three subjects experience a DLT, escalation is stopped; the preceding dose level is declared the maximum tolerated dose (MTD).
If > 1 subject experiences a DLT at any dose level, no further escalation will occur per protocol, and the preceding cohort will be designated the MTD.
If no DLT is observed at the highest predefined dose (4 × 10⁶ cells/kg), the investigator and the Sponsor will jointly determine whether exploration of higher doses is warranted.

Eligible subjects will be randomized to an investigational arm or a control arm.

If only one investigational dose is selected, the randomization ratio will be investigational arm : control arm = 2 : 1.
If two investigational doses are selected, the randomization ratio will be low-dose group : high-dose group : control group = 2 : 2 : 1.

Each investigational cohort will enroll 20-30 subjects, and the control cohort will enroll 10-15 subjects; the control group will receive standard-of-care treatment only. The total anticipated enrollment for Phase II is 30-75 subjects.

Conditions: Decompensated Cirrhosis
Being tested: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), Cohort 3 (4.0 × 10⁶ cells/kg)
Keywords: Patients with decompensated cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cohort 1 (1.0 × 10⁶ cells/kg)Drug
Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited.
Cohort 2 (2.0 × 10⁶ cells/kg)Drug
Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited.
Cohort 3 (4.0 × 10⁶ cells/kg)Drug
Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited.

Study groups in NCT07488546
Study group	Role	What they receive
Phase I：Cohort 1 (1.0 × 10⁶ cells/kg)	Experimental	Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited. Receives: Drug: Cohort 1 (1.0 × 10⁶ cells/kg)
Phase I：Cohort 2 (2.0 × 10⁶ cells/kg)	Experimental	Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited. Receives: Drug: Cohort 2 (2.0 × 10⁶ cells/kg)
Phase I：Cohort 3 (4.0 × 10⁶ cells/kg)	Experimental	Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited. Receives: Drug: Cohort 3 (4.0 × 10⁶ cells/kg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting toxicity (DLT).
Grade ≥ 3 non-hematologic toxicity
Measured: Within 29 days after administration
Types and incidence of treatment-related adverse events during the DLT observation period.
Types and incidence of treatment-related adverse events during the DLT observation period.
Measured: Within 29 days after administration

Secondary outcomes (6)

Secondary Endpoint
Changes in Child-Pugh score (see Appendix 1) from baseline at Week 12, 24, and 48 post-treatment;
Measured: From enrollment to the end of treatment at 48 weeks
Secondary Endpoint
Changes in MELD score (see Appendix 4) from baseline at Week 12, 24, and 48 post-treatment;
Measured: From enrollment to the end of treatment at 48 weeks
Secondary Endpoint
Change in Liver Function Indicators from Baseline: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), Alkaline Phosphatase (ALP), Albumin (ALB)
Measured: baseline , Week 4, Week 12,Week 24, Week 48 after administration
Secondary Endpoint
Change in Liver hematologic parameters from Baseline:White Blood Cell(WBC), Red Blood Cell(RBC), Hemoglobin(Hb), Blood platelet (PLT)
Measured: baseline , Week 4, Week 12,Week 24, Week 48 after administration
Secondary Endpoint
Prothrombin Time from Baseline
Measured: baseline , Week 4, Week 12,Week 24, Week 48 after administration
Secondary Endpoint
Changes in portal hypertension-related functional parameter-HVPG from baseline at Week 24 and 48 post-treatment;
Measured: From enrollment to the end of treatment at 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202530 Dec 2028

First posted23 Mar 2026
Study start23 Sep 2025
Primary completion30 Apr 2027 (estimated)
Study completion30 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 39 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07488546
Sponsor's protocol ID: HI-HCL001CT-01
Other IDs: CTR20253647
Acronym: HCL001
Status last verified: Mar 2026
First submitted: 24 Nov 2025
Last updated: 23 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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