Delayed Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

This study involves the use of a combination of an enriched hematopoetic stem cell infusion
(stem cells, produced by the bone marrow, generate the cells that form the blood elements,
help fight infection and assist in clotting) and kidney transplantation from the same donor
to try to avoid the need for long-term anti-rejection drug therapy. The desired result of
this study is to allow your body to develop "tolerance" to the transplanted kidney.
Tolerance means that your body would see the transplanted kidney as part of you and not try
to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents
must be taken on a daily basis. The purpose of this study is to determine if this procedure
is safe and to try to substantially reduce or even eliminate the need for anti-rejection
medications.

Inclusion Criteria:

- Patient has received a renal transplant only

- The original donor for the patient must be willing to participate in the study and
meet all of the donor eligibility criteria

- Patient must be between the ages of 18 and 65 years

- The crossmatch is negative between donor and recipient within 30 days of the FCRx
infusion

- Potential recipients who are women of child bearing potential must have a negative
pregnancy test (urine test is acceptable) within 48 hours prior to receiving
Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception
for 1 year following FCRx infusion

- No evidence of donor-specific antibody presently or historically

- Panel Reactive Antibody (PRA) less than or equal to 20% within 30 days of the FCRx
infusion

Note: The subjects do not need to be local residents in order to be eligible for this
trial, but must be willing to reside in the area, or within a four hour drive, for the
first month of the protocol so that we can monitor them closely in the early post stem
cell transplant period. As long as there is insurance or funding that will cover the cost
of the stem cell transplant and any research related complications, it is not necessary
for the subjects to be US citizens to participate in this trial.

Exclusion Criteria:

- Clinically active bacterial, fungal, viral or parasitic infection

- Pregnancy

- Clinical or serologic evidence of viral infection which would preclude the recipient
from receiving an FCRx infusion

- Previous radiation therapy at a dose which would preclude Total Body Irradiation
(TBI)

- Positive crossmatch between donor and recipient

- Evidence for immunologic memory against donor

- Body Mass Index (BMI) greater than 35 or less than 18

- Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human
Immunodeficiency Virus (HIV)

- Uncontrolled concomitant infection or any other unstable medical condition that could
interfere with the study objectives.

- Patients with impaired organ function, such as left ventricular ejection fraction
(LVEF) less than 35% or forced expiratory volume at one second (FEV1), forced
expiratory volume (FEV), or diffusing capacity of the lung for carbon monoxide (DLCO)
less than 50%, or transaminases greater than 4 times the upper limit of normal will
be excluded from participation. Biopsy proven rejection episode.

- Insufficient funds for bone marrow processing costs