Human Mesenchymal Stem Cells Induce Liver Transplant Tolerance
Recruitment status was: Recruiting
|Evidence of Liver Transplantation||Drug: Conventional plus UC-MSC Drug: Conventional plus placebo||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Human Umbilical Cord Mesenchymal Stem Cell Induce Liver Allografts Tolerance|
- Incidence rate of acute rejection and early liver function recovery [ Time Frame: 48 weeks ]
- Patient and graft survival, and prevalence of adverse events [ Time Frame: 48 weeks ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Conventional plus UC-MSC
Participants will receive conventional treatment plus a dose of UC-MSC from day 0 through the week 12 study visit. Participants will then be followed until the week 48 study visit
Drug: Conventional plus UC-MSC
Received conventional treatment and taken i.v., once per 4 week, at a dose of 1×106 UC-MSC/kg body weight for 12 weeks.
Other Name: Immunosuppressive agents plus umbilical cord stem cells
Placebo Comparator: Conventional plus placebo
Participants will receive conventional plus placebo treatment from day 0 through the week 12 study visit. Participants will then be followed until the week 48 study visit.
Drug: Conventional plus placebo
Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.
Other Name: Immunosuppressive agents plus saline
Liver transplantation is the only lifesaving intervention for patients with end-stage liver diseases. The current immunosuppressive agents reduce the incidence of acute cellular rejection; however, the rate of acute rejection reaches to 20-50% after liver transplantation. Furthermore, the long-term side effects of these regimens now has become a major challenge for liver transplant recipients and is increasingly being perceived as an unmet clinical need, for example, increases in the incidence of bacterial, viral infections, nephrotoxicity with chronic renal impairment, de novo diabetes mellitus, hyperlipidemia, arterial hypertension, cardiovascular disease, osteoporosis, neurotoxicity, hematological toxicity.
Mesenchymal stem cells (MSC) appeared to be effective in regulating the invoked immune response in setting such as tissue injury, transplantation, and autoimmunity, and have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s). Current clinical trails demonstrated that the use of autologous bone marrow MSC (BM-MSC) for renal transplanted patients resulted in lower incidence of acute rejection, decreased risk of opportunistic infection, and better estimated renal function. Compared with BM-MSC, umbilical cord derived MSC (UC-MSC) may be the better choice for clinical application. One main reason is that the collection of BM-MSC from liver transplanted patients would be harmful for the patients. Moreover, the proliferative abilities of BM-MSC from patients with liver disease are deficient, whereas, UC-MSC can be obtained from discarded umbilical cords and can be produced on a larger scale. Our and other studies reported that the infusion of human UC-MSC are feasible and can improve liver function of liver fibrosis and liver failure.
The purpose of this study is to learn whether and how UC-MSC can improve the conditions in liver transplanted patients. This study will also look at how well UC-MSC is tolerated and its safety in liver transplanted patients.
Participants in the study will be randomly assigned to one of two treatment arms:
Arm A: Participants will receive 12 weeks of standard regular immunosuppressive agents plus UC-MSC treatment. Arm B: Participants will receive 12 weeks of standard regular immunosuppressive agents plus placebo. UC-MSC will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are given via i.v. under sonography monitoring. After UC-MSC transfusion, patients are followed up at week 4, 8, 12, 24, 36 and 48, and the evaluation of liver function recovery was performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690247
|Contact: Fu-Sheng Wang, PHD||86-10-63879735 ext firstname.lastname@example.org|
|Contact: Ming Shi, PHD||86-10-63879735 ext email@example.com|
|Beijing 302 Hospital||Recruiting|
|Beijing, China, 100039|
|Contact: Fu-Sheng Wang, PHD 86-10-63879735 ext 2015.12 firstname.lastname@example.org|
|Contact: Ming Shi, PHD 86-10-63879735 ext 2015.12 email@example.com|
|Principal Investigator: Fu-Sheng Wang, PHD|
|Sub-Investigator: Zhenwen Liu, Doctor|
|Sub-Investigator: Ming Shi, PHD|
|Principal Investigator:||Fu-Sheng Wang, PHD||Beijing 302 Hospital|