a study on Liver Transplant
The purpose of this study is look at the safety of: - Taking a specific combination of immunosuppressant drugs after liver transplantation - Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells (darTregs) while taking this specific combination of drugs
Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Liver Transplantation (RTB-002)
After liver transplantation, immunosuppressants must be taken every day to prevent the body from injuring the transplanted liver by a process called rejection. People who take these drugs may experience side effects.
Studies show that some of body's cells, called T regulatory cells (Tregs), may play a part in accepting the transplanted liver. The investigators are learning about whether scientists can take Tregs from the blood of a liver transplant recipient and teach them to protect the transplanted liver from rejection. In the laboratory, the recipient Tregs are exposed to cells from the liver donor. Research data suggests that giving these "donor reactive" Tregs back to the transplant recipient might allow a liver transplant recipient to take lower doses of immunosuppressants, or perhaps to stop them altogether, without rejecting the liver.
Liver Transplantation Donor-Alloantigen-Reactive Regulatory T Cell Therapy Tregs Cell- and Tissue-Based Therapy Immunotherapy, Adoptive Liver Extracts Prednisolone acetate Methylprednisolone acetate Prednisone Methylprednisolone Hemisuccinate Methylprednisolone Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Everolimus Mycophenolic Acid Tacrolimus Antilymphocyte Serum Mycophenolate mofetil Ganciclovir triphosphate Valganciclovir Anti-Infective Agents Ganciclovir Diphenhydramine Promethazine Acetaminophen
Open to people ages 21–70
Detectable circulating HCV RNA.
Everolimus Conversion Criteria C2 (assessed prior to conversion to EVR based IS regimen;EVR cannot be initiated prior to 30 days after liver transplantation). Subjects with any of the following will remain on TAC-based IS regimen.
Platelets <50,000/μL within 7 days prior to conversion
*Below are exclusion criteria to be assessed prior to darTreg infusion for subjects in Cohorts 2, 3, and 4 only. Subjects in Cohort 2, 3, or 4 who meet any of these criteria should not receive a darTreg-infusion:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02188719.
© The Regents of the University of California