Ischemic-type Biliary Lesions Clinical Trial
Official title:
Umbilical Cord Mesenchymal Stem Cells Transplantation for Treatment of Patients With Ischemic-type Biliary Lesions After Liver Transplantation
Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions after liver transplantation.
Advances in organ preservation techniques, immunosuppressive regimens, and surgical
techniques have resulted in reduced rates of infection, acute rejection and vascular
complications after orthotopic liver transplantation (OLT). However, ischemic-type biliary
lesions (ITBLs) are still one of the most serious complications after OLT, with a usual
reported incidence of 5-15%, and an incidence of up to 26% in some studies. 46% patients
with ITBLs require re-transplantation after 2 years of OLT.
Mesenchymal stem cells (MSCs),a kind of pluripotent stem cells,can differentiate into
vascular endothelial cells, which participate in angiogenesis in ischemic tissue. MSCs can
also stimulate the proliferation and migration of mature endothelial cells via
paracrine.Furthermore, MSCs secret a variety of cytokines and growth factors, such as
vascular endothelial growth factor, human basic fibroblast growth factor, hepatocyte growth
factor, interleukin-1 and interleukin-8, etc., which also induce angiogenesis.
Participants in the study will be randomly assigned to one of two treatment arms:
- Arm A: Participants will receive 6 months of standard regular treatment for ITBLs plus
huc-MSCs treatment.
- Arm B: Participants will receive 6 months of standard regular treatment for ITBLs plus
placebo.
huc-MSCs will be prepared according to standard procedures and is collected in plastic bags
containing anti coagulant. MSCs are given via i.v. After huc-MSCs transfusion, patients are
followed up once per week(in the first months,<1M),once per 2 week(1-3M)and once per
month(3-6M), and the evaluation of liver function and biliary blood supply was performed.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention