Cell injection aims to repair damaged livers in early trial
NCT ID NCT07488546
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a single injection of HCL001 cells in 39 people with decompensated cirrhosis, a severe form of liver disease. The study aims to check safety and see if the treatment can improve liver function. Participants receive one of three dose levels, and researchers will monitor them for up to 48 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HCL001 cell injection (a type of cell therapy)
- What this could lead to
- If successful, this could point toward a new treatment that improves liver function and reduces complications in people with advanced liver disease.
- What could go wrong
- This is a very early (Phase 1/2) trial with only 39 participants, so safety and effectiveness are not yet proven. Cell therapies can have unknown risks, and the results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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: 1. Decompensated heart failure (NYHA Class III-IV); 2. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospita
Shanghai, Shanghai Municipality, China
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Other studies related to the condition(s) this trial covers.
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