drugset / Trial / NCT01446484
Treatment of Children With Kidney Transplants by Injection of CD4+CD25+FoxP3+ T Cells to Prevent Organ Rejection
Phase 1/2
Unknown
30 enrolled
Pirogov Russian National Research Medical University
Russian Academy of Medical Sciences · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-10
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD4+CD25+CD127lowFoxP3+ T regulatory cells | Cell therapy | 2e+08 cells | Subcutaneous |
| Background | Alemtuzumab | Monoclonal antibody | — | Intravenous |
| Background | Cyclosporine | Peptide | — | — |
| Background | Everolimus | Small molecule | — | Oral |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
| Background | Sirolimus | Small molecule | — | Oral |
| Background | Tacrolimus | Small molecule | — | — |