Liver Diseases Clinical Trial
— ABMSCIFTLDOfficial title:
Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases.
This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi) therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while control group will only receive drugs therapy.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 2020 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Definite liver diseases (such as viral hepatitis, autoimmune liver diseases, fatty liver diseases, ect); 2. Active bone marrow hyperplasia showed by bone marrow biopsy before ABMSCi; 3. Age between 18 and 60 years; 4. Abnormal liver function. Exclusion Criteria: 1. Enlisted for liver transplantation 2. Diagnosis of hepatocellular carcinoma or other cancers 3. Other severe medical disease, and acute infection 4. pregnant or nursing females,co-infections with HIV ,serious bacterial infection 5. other vital organ or system dysfunction 6. with severe complications of liver cirrhosis 7. hematological disorder |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Wenzhou Medical University |
China,
Chen Y, Chen S, Liu LY, Zou ZL, Cai YJ, Wang JG, Chen B, Xu LM, Lin Z, Wang XD, Chen YP. Mesenchymal stem cells ameliorate experimental autoimmune hepatitis by activation of the programmed death 1 pathway. Immunol Lett. 2014 Dec;162(2 Pt B):222-8. doi: 10 — View Citation
Deng Q, Cai T, Zhang S, Hu A, Zhang X, Wang Y, Huang J. Autologous Peripheral Blood Stem Cell Transplantation Improves Portal Hemodynamics in Patients with Hepatitis B Virus-related Decompensated Cirrhosis. Hepat Mon. 2015 Dec 20;15(12):e32498. doi: 10.58 — View Citation
Ma XR, Tang YL, Xuan M, Chang Z, Wang XY, Liang XH. Transplantation of autologous mesenchymal stem cells for end-stage liver cirrhosis: a meta-analysis based on seven controlled trials. Gastroenterol Res Pract. 2015;2015:908275. doi: 10.1155/2015/908275. Epub 2015 Mar 15. Review. — View Citation
Mohamadnejad M, Vosough M, Moossavi S, Nikfam S, Mardpour S, Akhlaghpoor S, Ashrafi M, Azimian V, Jarughi N, Hosseini SE, Moeininia F, Bagheri M, Sharafkhah M, Aghdami N, Malekzadeh R, Baharvand H. Intraportal Infusion of Bone Marrow Mononuclear or CD133+ — View Citation
Peng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.10 — View Citation
Xu L, Gong Y, Wang B, Shi K, Hou Y, Wang L, Lin Z, Han Y, Lu L, Chen D, Lin X, Zeng Q, Feng W, Chen Y. Randomized trial of autologous bone marrow mesenchymal stem cells transplantation for hepatitis B virus cirrhosis: regulation of Treg/Th17 cells. J Gast — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline alanine aminotransferase at 6 months | alanine aminotransferase (ALT) | baseline and 6 months after treatment | No |
Primary | Change from baseline aspartate aminotransferase at 6 months | aspartate aminotransferase (AST) | baseline and 6 months after treatment | No |
Primary | Change from baseline total bilirubin at 6 months | total bilirubin (TBil) | baseline and 6 months after treatment | No |
Primary | Change from baseline direct bilirubin at 6 months | direct bilirubin (DBil) | baseline and 6 months after treatment | No |
Primary | Change from baseline total bile acid at 6 months | total bile acid (TBA) | baseline and 6 months after treatment | No |
Primary | Change from baseline albumin at 6 months | albumin (ALB) | baseline and 6 months after treatment | No |
Primary | Change from baseline prothrombin time at 6 months | prothrombin time (PT), | baseline and 6 months after treatment | No |
Primary | Change from baseline international normalized ratio at 6 months | international normalized ratio (INR) | baseline and 6 months after treatment | No |
Primary | Change from baseline white blood cell at 6 months | white blood cell (WBC) | baseline and 6 months after treatment | No |
Primary | Change from baseline platelet at 6 months | platelet (PLT) | baseline and 6 months after treatment | No |
Secondary | Change from baseline liver density at 6 months | Low density, medium density, high density tested by abdominal B ultrasound/CT/MRI | baseline and 6 months after treatment | No |
Secondary | Change from baseline liver size at 6 months | Enlarged size, normal size, shrunken size tested by abdominal B ultrasound/CT/MRI | baseline and 6 months after treatment | No |
Secondary | Change from baseline spleen thickness at 6 months | tested by abdominal B ultrasound/CT/MRI | baseline and 6 months after treatment | No |
Secondary | Incidence of adverse events that are related to treatment | Postoperative pyrexia, infection, liver cirrhosis, ascites, upper gastrointestinal hemorrhage, malignant tumors of liver and other organs | baseline and 6 months after treatment | Yes |
Secondary | Number of participants that survive without developing disease | 12 months after treatment | Yes | |
Secondary | Number of participants that survive with developing disease | 12 months after treatment | Yes | |
Secondary | Number of participants that die after treatment | 12 months after treatment | Yes |
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