common.study.topics.clinical

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

common.study.values.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.

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participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

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common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

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

participant.views.study.view.additional

participant.views.study.view.scientific-title

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

common.study.values.clinical-trial-id

NCT03726307

participant.views.study.view.id

dR6LRd