Human Mesenchymal Stem Cells Induce Liver Transplant Tolerance
NCT ID: NCT01690247
Last Updated: 2013-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2012-02-29
2015-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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.
Conventional plus placebo
Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.
Interventions
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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.
Conventional plus placebo
Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must be between the ages of 18 and 70 years and meet the criteria for liver transplantation.
3. Patient is receiving the first liver transplant.
4. Patient is receiving a liver transplant only.
5. Negative pregnancy test (female patients in fertile age).
6. Willing to comply with the study visits.
Exclusion Criteria
2. Vital organs failure (Cardiac, Renal or Respiratory, et al).
3. Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
4. Currently receiving any immunosuppressive agent.
5. Clinically active bacterial, fungal, viral or parasitic infection.
6. Pregnant or lactating women.
7. Other candidates who are judged to be not applicable to this study by investigators.
18 Years
70 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Responsible Party
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Fu-Sheng Wang
Research Center for Biotherapy
Principal Investigators
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Fu-Sheng Wang, PHD
Role: PRINCIPAL_INVESTIGATOR
Beijing 302 Hospital
Locations
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Beijing 302 Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Fu-Sheng Wang, PHD
Role: primary
Ming Shi, PHD
Role: backup
References
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Tan J, Wu W, Xu X, Liao L, Zheng F, Messinger S, Sun X, Chen J, Yang S, Cai J, Gao X, Pileggi A, Ricordi C. Induction therapy with autologous mesenchymal stem cells in living-related kidney transplants: a randomized controlled trial. JAMA. 2012 Mar 21;307(11):1169-77. doi: 10.1001/jama.2012.316.
Perico N, Casiraghi F, Introna M, Gotti E, Todeschini M, Cavinato RA, Capelli C, Rambaldi A, Cassis P, Rizzo P, Cortinovis M, Marasa M, Golay J, Noris M, Remuzzi G. Autologous mesenchymal stromal cells and kidney transplantation: a pilot study of safety and clinical feasibility. Clin J Am Soc Nephrol. 2011 Feb;6(2):412-22. doi: 10.2215/CJN.04950610. Epub 2010 Oct 7.
Le Blanc K, Frassoni F, Ball L, Locatelli F, Roelofs H, Lewis I, Lanino E, Sundberg B, Bernardo ME, Remberger M, Dini G, Egeler RM, Bacigalupo A, Fibbe W, Ringden O; Developmental Committee of the European Group for Blood and Marrow Transplantation. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet. 2008 May 10;371(9624):1579-86. doi: 10.1016/S0140-6736(08)60690-X.
Shi M, Liu ZW, Wang FS. Immunomodulatory properties and therapeutic application of mesenchymal stem cells. Clin Exp Immunol. 2011 Apr;164(1):1-8. doi: 10.1111/j.1365-2249.2011.04327.x. Epub 2011 Feb 24.
Zhang Z, Lin H, Shi M, Xu R, Fu J, Lv J, Chen L, Lv S, Li Y, Yu S, Geng H, Jin L, Lau GK, Wang FS. Human umbilical cord mesenchymal stem cells improve liver function and ascites in decompensated liver cirrhosis patients. J Gastroenterol Hepatol. 2012 Mar;27 Suppl 2:112-20. doi: 10.1111/j.1440-1746.2011.07024.x.
Other Identifiers
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Beijing302-008
Identifier Type: -
Identifier Source: org_study_id