Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Location status: Recruiting
Location contact
ShaLing Li, doctor
CONTACT
Xuegong Fan, doctor
CONTACT
NCT Number: NCT03826433
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1
Changsha, Hunan, 410008, China
Location status: Recruiting
ShaLing Li, doctor
CONTACT
Xuegong Fan, doctor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6*10^7 cells
Time frame: 12 month
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
To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment
Time frame: 12 month
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
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
After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).
Time frame: 12 month
Fibro-Touch examination
Time frame: 12 month
To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment
Contact information is provided by the study sponsor or research team.
Lei Guo, doctor
CONTACT
Xuegong Fan, doctor
CONTACT
Sclnow Biotechnology Co., Ltd.
Industry
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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