- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02223897
Mesenchymal Stem Cells Transplantation for Ischemic-type Biliary Lesions
Umbilical Cord Mesenchymal Stem Cells Transplantation for Treatment of Patients With Ischemic-type Biliary Lesions After Liver Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Yang yang, MD
- Email: yysysu@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510630
- Recruiting
- Third Affiliated Hospital, Sun Yat-Sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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).
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of ITBLs
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in biliary enzymology
Time Frame: 18 months
|
18 months
|
|
Biliary blood supply
Time Frame: 18 months
|
Biliary blood supply indicated by contrast-enhanced ultrasound.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
life quality
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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