Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cell injection aims to repair damaged livers in early trial

NCT ID NCT07488546

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Decompensated cirrhosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospita

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.