NCT03826433 hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
| NCT ID | NCT03826433 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sclnow Biotechnology Co., Ltd. |
| Condition | Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2018-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2018-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. 2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. 3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
Eligibility 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;
Contact & Investigator
Xuegong Fan, doctor
STUDY DIRECTOR
Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT03826433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03826433 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03826433 currently recruiting?
Yes, NCT03826433 is actively recruiting participants. Contact the research team at georgeguo@sclnow.com for enrollment information.
Where is the NCT03826433 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT03826433 clinical trial?
NCT03826433 is sponsored by Sclnow Biotechnology Co., Ltd.. The principal investigator is Xuegong Fan, doctor at Xiangya Hospital of Central South University. The trial plans to enroll 20 participants.