Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study
Running, not enrolling · Phase 1
Conditions studied: Kidney Transplant, Renal Transplant Recipients
In brief
This study will evaluate the safety and feasibility of treatment involving a single infusion of donor-derived regulatory dendritic cells (DCreg) in first time, living donor renal transplant recipients. 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. This study will enroll 28 subjects (14 recipients, 14 donors). The duration of follow-up will be: * 1 week following the leukapheresis procedure for donors and * 2 years following their DCreg infusion for kidney recipients.
Key facts
- Study ID
- NCT03726307
- Run by
- Angus W. Thomson PhD DSc
- People needed
- 28
- Starts
- 2019-04-10
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Donor Eligibility Criteria:
- Able to understand and provide informed consent;
- Male or female >/= 18 years of age
- Meets all standard institutional criteria for kidney donation and Health Agency criteria for kidney donation;
- For females of childbearing potential, a negative urine or serum pregnancy test;
- 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;
- Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and core antibody), and Treponema pallidum infection;
- Negative for West Nile Virus;
- Negative health history for Creutzfeldt-Jakob disease;
- No live vaccines within 8 weeks prior to leukapheresis;
- No medical condition(s) that the investigator deems incompatible with participation in the trial; and
- No use of investigational drugs within 12 weeks of participation.
- Recipient Inclusion Criteria:
- Must be able to understand and provide informed consent;
- Is >/= 18 years old at the time of informed consent;
- Is undergoing a living donor renal transplant;
- For females of childbearing potential, a negative urine or serum pregnancy test upon study entry
- The candidate agrees to use contraception with a method that is more than 80% effective (see FDA Office of Women's Health (http://www.fda.gov/birthcontrol). Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) to be used from one month before study treatment begins until one month after study completion;
- Cytomegalovirus (CMV) seropositive or, if CMV seronegative must be receiving a kidney from a CMV seronegative donor;
- Has a negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON®-Gold TB or T-SPOT-TB assay OR has completed treatment for latent tuberculosis and has a negative chest x-ray. PPD or IGRA testing must occur within 52 weeks before transplant. These requirements apply as well to prior recipients of Bacille Calmette-Guérin (BCG) vaccination;
- Meets all standard institutional and Health Agency criteria for kidney transplant.
- Vaccines up to date as per DAIT guidance for patients in transplant trials (Refer to Manual of Operations).
- Study Exclusion Criteria:
- Panel Reactive Antibody (PRA >20%);
- Positive T or B Cell Flow Crossmatch prior to transplant;
Where it is running
- University of Pittsburgh, Starzl Transplantation Institute — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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