A Phase 1 interventional study of Peripheral iv in Hepatitis B, sponsored by Sclnow Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Sclnow Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment
This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy,
This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 20 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Sclnow Biotechnology Co., Ltd. is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6\*10\^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 \* 10 \^ 7 (30 ml)
Biological: Peripheral iv
Control Group: Using basic contrast .
6\*10\^7 cells
Validity evaluation by detection of the Model for end-stage Liver Disease score of participants
After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. 40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality \<9 - 1.9% observed mortality
Time frame: 12 month
Safety evaluation by detecting Blood routine
To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment
Time frame: 12 month
Validity evaluation by detection of the child-pugh of participants
After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%
Time frame: 12 month
Validity evaluation by detection of the coagulation function of participants
After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures. The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.
Time frame: 12 month
Imaging examination
After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).
Time frame: 12 month
Imaging examination
Fibro-Touch examination
Time frame: 12 month
Safety evaluation by detecting adverse events and serious adverse events
To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment
Time frame: 12 month
Plan to share: No
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Sclnow Biotechnology Co., Ltd.