NCT01690247

Brief Summary

Liver transplantation is the only lifesaving intervention for patients with end-stage liver diseases. Despite the ability of current immunosuppressive agents to reduce the incidence of acute rejection, the rate of acute rejection reaches to 20-50% after liver transplantation. Furthermore, the long-term toxicity associated with current regimens for liver transplant recipients now is increasingly being perceived as an unmet clinical need. 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). Here, we evaluate umbilical cord derived MSC (UC-MSC) as an alternative immunosuppressive agents for liver transplanted patients, and examine if UC-MSC could improve the recovery of liver function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

September 19, 2012

Last Update Submit

May 30, 2013

Conditions

Evidence of Liver Transplantation

Keywords

mesenchymal stem cellsliver transplantationclinical trialrejection

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of acute rejection and early liver function recovery

    48 weeks

Secondary Outcomes (1)

  • Patient and graft survival, and prevalence of adverse events

    48 weeks

Study Arms (2)

Conventional plus UC-MSC

EXPERIMENTAL

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

Conventional plus placebo

PLACEBO COMPARATOR

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

Interventions

Conventional plus UC-MSCDRUG

Received conventional treatment and taken i.v., once per 4 week, at a dose of 1Ă—106 UC-MSC/kg body weight for 12 weeks.

Also known as: Immunosuppressive agents plus umbilical cord stem cells
Conventional plus UC-MSC
Conventional plus placeboDRUG

Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.

Also known as: Immunosuppressive agents plus saline
Conventional plus placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Patients must be between the ages of 18 and 70 years and meet the criteria for liver transplantation.
  • Patient is receiving the first liver transplant.
  • Patient is receiving a liver transplant only.
  • Negative pregnancy test (female patients in fertile age).
  • Willing to comply with the study visits.

You may not qualify if:

  • Previously received or is receiving an organ transplant other than a liver.
  • Vital organs failure (Cardiac, Renal or Respiratory, et al).
  • Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
  • Currently receiving any immunosuppressive agent.
  • Clinically active bacterial, fungal, viral or parasitic infection.
  • Pregnant or lactating women.
  • Other candidates who are judged to be not applicable to this study by investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing 302 Hospital

Beijing, 100039, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22436957RESULT

  • 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.

    PMID: 20930086RESULT

  • 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.

    PMID: 18468541RESULT

  • 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.

    PMID: 21352202RESULT

  • 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.

    PMID: 22320928RESULT

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Congresses as TopicImmunosuppressive AgentsSodium Chloride

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsImmunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Fu-Sheng Wang, PHD

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu-Sheng Wang, PHD

CONTACT

86-10-63879735fswang302@163.com

Ming Shi, PHD

CONTACT

86-10-63879735shiming302@sina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Center for Biotherapy

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 21, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

CN(1)