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UPMC Transplant Services The Aging Institute UPMC Hillman Cancer Center

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

This is a single center, open-label, dose escalation, Phase 1 study to test the safety and feasibility of a single infusion of donor-derived DCreg in de novo living donor renal transplant recipients who will receive mycophenolic acid (MPA), tacrolimus (Tac), and steroid maintenance immunosuppressive therapy without antibody induction. Subjects will not be withdrawn from known effective therapy for the purpose of participating in this research.

DCreg will be prepared from monocytes obtained by leukapheresis from prospective (non-mobilized) living kidney donors and infused into the respective recipients 7 days before renal transplantation. Half dose MPA will be administered concomitant with the DCreg infusion. Study duration will be 5 years (3 years accrual + 2 years follow-up).

Three doses of DCreg will be tested in 3 groups of recipients as follows:

  • Dose 1: 0.5 (+/- .1) million cells /kg recipient body wt (3 patients)
  • Dose 2: 1.2 (+/- .2) million cells/kg recipient body wt (3 patients)
  • Dose 3: 2.5-5.0 million cells/kg recipient body wt (8 patients)

Trial Eligibility

This study is open to adults between the ages of 18 and 65. For additional requirements and criteria please visit ClinicalTrials.gov.

Start Date: May 2019
End Date: July 2023

Learn more about this trial on its clinicaltrials.gov page or call Mindi Styn, PhD at 412-383-8884.

Lab Team

Principal Investigators:

Amit Tevar, MD
Angus Thomson, PhD, DSc

Contact Information

For more information, call the UPMC Immune Transplant and Therapy Center at 1-888-4UPMC-ITTC (1-888-487-6248).

UPMC
200 Lothrop St.
Pittsburgh, PA 15213-2582

Additional Resources

For patients:
UPMC Transplant Services
Immunotherapy at UPMC Hillman Cancer Center
The Aging Institute

For researchers:
Thomas E. Starzl Transplantation Institute
Cancer Immunotherapy Research at UPMC Hillman Cancer Center
University of Pittsburgh Department of Immunology

© 2023 UPMC – The UPMC Immune Transplant and Therapy Center is a partnership between UPMC and the University of Pittsburgh.

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