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

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pirogov Russian National Research Medical University
• Collaborator: Russian Academy of Medical Sciences
• Treatments: Alemtuzumab; Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Weight greater than 10 kg ( lbs)

• Will be receiving a living-related primary kidney allograft

• Negative B-cell and T-cell cytotoxic and flow cytometry crossmatch

• Normal echocardiogram (ECG) with an ejection fraction of greater than 50%

• Received full course of vaccination for hepatitis B virus (HBV), completed at least 6 weeks before transplantation, OR has naturally acquired immunity

• Parents willing to comply with the study visits

Exclusion Criteria:

• Previously received or is receiving an organ transplant other than a kidney

• Receiving an ABO incompatible donor kidney

• HIV infected

• 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 within the 5 years prior to study entry. Patients who have had successfully treated nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are not excluded.

• Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry

• 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