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Trial record 96 of 799 for:    Interventional Studies | mesenchymal

Mesenchymal Stem Cells Transplantation for Ischemic-type Biliary Lesions

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ClinicalTrials.gov Identifier: NCT02223897
Recruitment Status : Unknown
Verified August 2014 by Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic-type Biliary Lesions Drug: huc-MSCs Drug: Placebo Phase 2 Phase 3

Detailed Description:

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.


Study Type : Interventional
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Umbilical Cord Mesenchymal Stem Cells Transplantation for Treatment of Patients With Ischemic-type Biliary Lesions After Liver Transplantation
Study Start Date : July 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conventional treatment, huc-MSCs
Received conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight.
Drug: huc-MSCs
Received conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight.
Other Name: Umbilical Cord-Derived Mesenchymal Stem Cells

Placebo Comparator: Conventional plus placebo
Received conventional treatment and 50 ml saline once per week for the first month and once per month for 6 months(9 times in total).
Drug: Placebo
Received conventional treatment and 50 ml saline solution once per week for the first month and once per month for 6 months(9 times in total).
Other Name: saline solution




Primary Outcome Measures :
  1. The incidence of ITBLs [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Changes in biliary enzymology [ Time Frame: 18 months ]
  2. Biliary blood supply [ Time Frame: 18 months ]
    Biliary blood supply indicated by contrast-enhanced ultrasound.


Other Outcome Measures:
  1. life quality [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • benign end-stage liver disease patients with liver transplantation.
  • ages of 18 and 60 years.
  • first liver transplant.
  • gamma-glutamyltransferase > 300 U/L for 2 weeks, and there was no or low enhancement of the wall of the hilar bile duct in arterial phase via contrast-enhanced ultrasonography.
  • Written informed consent.

Exclusion Criteria:

  • second or combined organ transplant recipient.
  • vital organs failure (Cardiac, Renal or Respiratory, et al).
  • clinically active bacterial, fungal, viral or parasitic infection.
  • other candidates who are judged to be not applicable to this study by investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223897


Contacts
Contact: Yang yang, MD yysysu@163.com

Locations
China, Guangdong
Third Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Yang Yang, PHD       yysysu@163.com   
Contact: Yingcai Zhang       76207884@qq.com   
Principal Investigator: Yang Yang, MD         
Sponsors and Collaborators
Yang Yang
Investigators
Study Chair: Yang Yang, MD Third Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Yang Yang, Department of Transplantation, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02223897     History of Changes
Other Study ID Numbers: 2014006
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014

Keywords provided by Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University:
Liver transplantation
Biliary complication
mesenchymal stem cells

Additional relevant MeSH terms:
Ischemia
Pathologic Processes