By InvitationEarly Phase 1

Safety, Tolerability, and Preliminary Efficacy of Hepatocyte-like Cell Injection for the Prevention and Treatment of Small-for-Size Syndrome

China12 participantsStarted 2025-12-17

Plain-language summary

To evaluate the safety, tolerability, and preliminary efficacy of rectus sheath injection of hepatocyte-like cells in the treatment and prevention of small-for-size syndrome, with the ultimate goal of improving patient survival.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Presence of severe, life-threatening extrahepatic systemic diseases.
. Uncontrolled active infection or hemorrhage.
. Pregnancy or lactation in female patients.
. History of severe allergic reactions or known hypersensitivity to CiPS-derived cell products or blood products.
. Inability to undergo phlebotomy due to peripheral vascular collapse.
. Inability or unwillingness to provide informed consent or comply with the study procedures.
. Unwillingness to receive CiPS-based therapy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events related to hepatocyte-like cell injection

Timeframe: within 7 days after injection

Plasma Ammonia

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Direct Bilirubin

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Total Bilirubin

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Aspartate Aminotransferase (AST)

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Alanine Aminotransferase (ALT)

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Trial details

NCT IDNCT07276568

SponsorZhi-Jun Zhu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-01

View on ClinicalTrials.gov More Small-for-size Syndrome trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Presence of severe, life-threatening extrahepatic systemic diseases.
. Uncontrolled active infection or hemorrhage.
. Pregnancy or lactation in female patients.
. History of severe allergic reactions or known hypersensitivity to CiPS-derived cell products or blood products.
. Inability to undergo phlebotomy due to peripheral vascular collapse.
. Inability or unwillingness to provide informed consent or comply with the study procedures.
. Unwillingness to receive CiPS-based therapy.

What they're measuring

Incidence of adverse events related to hepatocyte-like cell injection

Timeframe: within 7 days after injection

Plasma Ammonia

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Direct Bilirubin

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Total Bilirubin

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Aspartate Aminotransferase (AST)

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.

Serum Alanine Aminotransferase (ALT)

Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.