Safety Study of Using Regulatory T Cells Induce Liver Transplantation Tolerance

NCT01624077 | Unknown Phase 1 DMC

• 1 other identifier: NJLT001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The first trial will involve the generation of donor alloantigen-specific CD4+CD25+ Tregs from peripheral blood of pre-transplant patients, the administration of the CD4+CD25+ Tregs (1 x 106 cells/kg) at several intervals (for graft specific tolerance induction).

Conditions

Chronic Rejection of Liver Transplant

Keywords

Regulatory T cells; Liver Transplantation; Rejection; Tolerance; Cell tolerance; Survival

Outcome Measures

Primary Outcomes (1)

• Patient and graft survival

  one year posttransplantation

Secondary Outcomes (3)

• Patient and graft survival

  3 years post transplantation

• Incidence rate of biopsy-proven acute or chronic organ rejection

  3 years post transplantation

• Incidence of adverse events associated with liver transplantation and immunosuppression

  3 years posttransplantation

Study Arms (1)

Regulatory T cells

EXPERIMENTAL

Naïve CD4+ T cells isolated from peripheral blood mononuclear cells were stimulated with GMP anti-CD3/CD28 coated beads in the presence of IL-2 ,TGF-β.

Biological: Regulatory T cells

Interventions

Regulatory T cells BIOLOGICAL

Tregs will inject after liver transplantation

Also known as: Treg

Regulatory T cells

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Weight greater than 50kg
• Will be receiving a living-related primary liver allograft
• Negative B-cell and T-cell cytotoxic and flow cytometry crossmatch
• Normal echocardiogram (ECG) with an ejection fraction of greater than 50%
• Parents willing to comply with the study visits

You may not qualify if:

• Current active infection
• Pregnant or breastfeeding
• Evidence of HIV infection or known HIV positive serology
• Antibody positive for hepatitis C virus
• Surface antigen positive for HBV
• Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB (positive Mantoux test)
• Current cancer or a history of cancer
• Uncontrolled concomitant infections, severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption, active peptic ulcer, or any other unstable medical condition that could interfere with this study
• Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant
• Currently receiving any immunosuppressive agent
• Anticipated contraindication to taking medications orally or via nasogastric tube by the morning of Day 2 following completion of the transplant procedure
• Require certain medications
• Known hypersensitivity to any of the study medications,
• Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
• Anticipated contraindication to study medications administration for longer than 5 days post-transplant

Sponsors & Collaborators

• Nanjing Medical University: lead
• University of Minnesota: collaborator

Study Sites (1)

Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Hong Wang, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Liver transplantation Center

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: June 20, 2012
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 24, 2015

Record last verified: 2014-12

Locations

CN (1)