This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.
Patients will undergo a standard of care deceased donor kidney transplant and thereafter the recipient will receive TLI (Total Lymphoid Irradiation)/single low dose Total Body Irradiation, ATG (Anti-Thymocyte Globulin) conditioning, followed by an infusion of whole bone marrow cells harvested from the same donor vertebral bodies. Patients will be receive standard of care doses of steroids, MMF and tacrolimus as part of their transplant immunosuppression. Subjects will be withdrawn from the immunosuppression if they have met the withdrawal criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
This combined kidney and hematopoietic cell transplants with a conditioning regimen with irradiation and ATG creates an environment of immune-tolerance. This promotes hematopoietic cell engraftment.
Stanford University
Palo Alto, California, United States
RECRUITINGMSOB
Stanford, California, United States
RECRUITINGNumber of patients out of the total patients enrolled who received both the kidney and the bone marrow from the same donor.
Time frame: 6 months
Determine the dose of TBI that will support donor CD3 Tcell chimerism between 30-75% at 45 days post infusion
TBI dose in cGy associated with donor Tcell chimerism of \>30 % immunosuppressive drug monotherapy.
Time frame: day 45
Number of patients who develop GVHD, all grades and types, within 60 months of kidney transplant
Time frame: 60 months
Number of patients with either bacterial, viral or fungal infection within 12 months post transplant .
Time frame: 12 months
Serum Creatinine
Time frame: up to 60 months
Panel-Reactive Antibody (PRA)
Report % of PRA on all participants
Time frame: Baseline, month 9, and month 12
Donor-Specific Antibody (DSA)
Report percentage of patients that develop DSA
Time frame: Baseline, month 9, and month 12
Percentage of subjects on immunosuppressive medications after an eighteen month post transplant till month 60.
Time frame: 60 months
Persistence of donor chimerism >1%
Percentage of patients with donor chimerism (any lineage)
Time frame: 3,6,9,12,15,18,24,48,60 months
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