Clinical Trial

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

Study Description

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - DCreg: 0.5 million cells/kg+SOC

DCreg 0.5 (±0.1) million cells/kilogram body weight infused as a single dose. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in r ...read more on ClinicalTrials.org

Biological - DCreg: 1.2 million cells/kg+SOC

DCreg 1.2 (±02) million cells/kilogram body weight infused as a single dose. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in re ...read more on ClinicalTrials.org

Biological - DCreg:2.5 to 5.0 million cells/kg+SOC

DCreg 2.5 to 5.0 million cells/kilogram body weight infused as a single dose. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in re ...read more on ClinicalTrials.org

Additional Information

Official Study Title

Allogeneic Regulatory Dendritic Cell (DCreg) Therapy in Live-Donor Renal Transplant Recipients

Clinical Trial ID

NCT03726307

ParticipAid ID

dR6LRd