Treatment of Children With Kidney Transplants by Injection of CD4+CD25+FoxP3+ T Cells to Prevent Organ Rejection

Summary

T regulatory cells (T regs) are responsible for immune tolerance in solid organ transplant patients. This study will evaluate the treatment of children with kidney transplants either with Campath and other immune system suppressing medications alone or in combination with injection of autologous CD4+CD25+CD127lowFoxP3+ T regulatory cells expanded ex vivo. The aim of this study is to develop a new strategy that will be more effective in preventing organ rejection and maintaining patient health.

Conditions

• End-Stage Renal Disease
• Kidney Failure

Interventions

BIOLOGICAL

CD4+CD25+CD127lowFoxP3+ T regulatory cells injection

Blood samples from patients in the experimental group will be collected twice with weekly interval in the amount of 70 ml/1,73 m2. T cells CD4+ will be separated from blood samples and frozen in liquid nitrogen. At day 30 after transplantation patients will undergo subcutaneous injection of approximately 2x 10\^8 autologous T regs, expanded from previously frozen CD4+ T cells. Levels of T reg cells in patient's blood will be estimated by flow cytometry in a week after injection. That cell injection procedure will be repeated at 6 months after transplantation

DRUG

Alemtuzumab

Immunosuppressant; 2 doses of drug by intravenous infusion on Days 14 - 21 before Tx and on Day 0 after Tx

DRUG

Mycophenolate mofetil

Immunosuppressant; oral daily dose starting Day 2-3 until withdrawal or end of the study

DRUG

Sirolimus

Immunosuppressant; oral daily dose starting no earlier then after Month 1 post-transplant until withdrawal or end of the study

DRUG

Tacrolimus

Immunosuppressant; daily dose starting Day 0 until withdrawal or end of the study

DRUG

Cyclosporine

Immunosuppressant; daily dose starting Day 0 until withdrawal or end of the study

DRUG

Everolimus

Immunosuppressant; oral daily dose starting no earlier then after Month 1 post-transplant until withdrawal or end of the study

PROCEDURE

Kidney transplantation

Living related kidney transplantation

Sponsors & Collaborators

• Russian Academy of Medical Sciences

  collaborator OTHER

• Pirogov Russian National Research Medical University

  lead OTHER

Principal Investigators

• Svetlana N. Bykovskaia, M.D. Ph.D. · Russian State Medical University

• Michael M. Kaabak, M.D. Ph.D. · Boris Petrovsky's Scientific Center of Surgery Russian Academy of Medical Sciencies

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2014-11-30

Completion

2014-11-30

Countries

• Russia

Study Locations