Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study (NCT03726307)

🧪 Interventions in This Study

• DCreg: 0.5 million cells/kg+SOC (BIOLOGICAL)
• DCreg: 1.2 million cells/kg+SOC (BIOLOGICAL)
• DCreg:2.5 to 5.0 million cells/kg+SOC (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Donor Eligibility Criteria:
2. Able to understand and provide informed consent;
3. Male or female \>/= 18 years of age
4. Meets all standard institutional criteria for kidney donation and Health Agency criteria for kidney donation;
5. For females of childbearing potential, a negative urine or serum pregnancy test;
6. Negative for Human Immunodeficiency Virus type 1 (HIV) -1 (antigen and Nucleic Acid Testing (NAT)), HIV-2, Human T-cell leukemia virus type 1 (HTLV-1), and HTLV-2;
7. Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and core antibody), and Treponema pallidum infection;
8. Negative for West Nile Virus;
9. Negative health history for Creutzfeldt-Jakob disease;
10. No live vaccines within 8 weeks prior to leukapheresis;
11. No medical condition(s) that the investigator deems incompatible with participation in the trial; and
12. No use of investigational drugs within 12 weeks of participation. Recipient Inclusion Criteria:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Pittsburgh, Starzl Transplantation Institute — Pittsburgh, Pennsylvania

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.