Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)

Four subjects were treated under compassionate use provisions under this study with
facilitating cell therapy (FCRx) and living donor kidney transplant.

Inclusion Criteria:

- Patient must be between the ages of 18 and 65 years and meet the institution's
criteria for renal transplantation for end-organ failure

- Patient is receiving first renal transplant

- Patient is receiving a renal transplant only

- The crossmatch is negative between donor and recipient

- Women who are of child bearing potential must have a negative pregnancy test (urine
test is acceptable) within 48 hours of initiating total body irradiation (TBI) and
agree to use reliable contraception for 1 year following transplant

- Potential donors 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)

- No evidence of donor-specific antibody presently or historically

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 a kidney transplant

- Previous radiation therapy at a dose which would preclude TBI

- Positive crossmatch between donor and recipient

- Evidence for immunologic memory against donor

- BMI >35 or <18

- Re-transplant

- Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV