Treg Adoptive Therapy for Subclinical Inflammation in Kidney Transplantation (NCT02088931) | Clinical Trial Compass
CompletedPhase 1
Treg Adoptive Therapy for Subclinical Inflammation in Kidney Transplantation
United States3 participantsStarted 2014-03
Plain-language summary
The purpose of this study is to test the safety of the experimental therapy of a single infusion of Regulatory T cells (Tregs). The investigators want to find out what effects, good or bad, Tregs will have on the kidney transplant patients.
There are different types of T cells. This study uses Regulatory T cells (Tregs), which are found in the blood and are part of the immune system that stops other immune cells from working. Tregs help to turn off the immune system after other immune cells have finished tackling outside infections, and Tregs keep the immune system in check so that the body does not attack itself. The researchers are hoping that, by giving an infusion of Tregs that the attack on the kidney can be stopped and kidney function will be stabilized. It is not known if the Treg experimental therapy can stop the inflammation in the kidney.
In this study, the researchers will take some of Tregs from the patient, multiply them in the laboratory, and then infuse them back into the patient. The procedure used to multiply Tregs is an experimental process performed in the laboratory. Similar procedures done with mice have been shown to reverse inflammation but it is not known whether the results will be the same in humans. This therapy has not yet been done in humans outside of a research study.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Recipients of primary renal transplants age 18-65 years with no donor specific antibodies prior to transplantation
✓. Stable renal function (cGFR), no history of acute rejection and proteinuria less than 500 mg/24 hours.
✓. Maintenance immunosuppression consisting of tacrolimus and mycophenolate mofetil/mycophenolic acid with or without prednisone
✓. Protocol renal allograft biopsy at 6 months with findings of 5%-25% inflammation (Banff t0 or t1)without evidence of rejection (Banff t0 or t1\<5%)
✓. Blood PCR for BK less than 1000 copies/ml, and urine less than 500,000 copies/ml
✓. History of positive EBV serology
✓. Current immunizations including TdAP, hepatitis B, pneumococcal and seasonal influenza vaccines
Exclusion criteria
✕. Recipients of 6-antigen HLA matched kidney transplants from living or deceased donors