Using stem cells to treat hepatitis B cirrhosis
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
This study is testing whether stem cells can help improve the health of adults with severe liver damage from hepatitis B cirrhosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sclnow Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT03826433 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of human umbilical mesenchymal stem cells in treating patients with decompensated hepatitis B cirrhosis. Participants aged 18-60 with a specific BMI range will receive peripheral intravenous injections of the stem cells. The study aims to observe the therapeutic effects and explore the underlying mechanisms of treatment. It is designed as a controlled trial comparing treatment and control groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with hepatitis B cirrhosis classified as Child-Pugh B or C.
Not a fit: Patients with end-stage cirrhosis complications or significant organ insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from hepatitis B cirrhosis.
How similar studies have performed: While the use of stem cells in liver diseases is an emerging field, this specific approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value; * The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points. * Have not received stem cell therapy in the recent 6 months; * Subjects will be able to sign the informed consent in accordance with the study procedures and instructions. Exclusion Criteria: * Insufficiency of vital organs, such as heart, kidney and lung; * End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc. * Concomitant peritonitis, pneumonia, or other types of infection not under control; * Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine; * Positive serum HIV antibody and syphilis antibody; * Alpha fetoprotein\>400ng/mL with primary liver cancer or without imaging evidence; * Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ; * Patients with severe mental illness and cognitive impairment;
Where this trial is running
Changsha, Hunan
- Xiangya Hospital Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Lei Guo, doctor
- Email: georgeguo@sclnow.com
- Phone: 861064368977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.