| Protocol Number: |
Version 2.1 6/27/2002 |
| Trial Phase: |
Phase I |
| Maximum # of Subjects: |
15 |
| IRB Number: |
WIRB IRB# 1051658 |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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| To determine whether the administration of donor bone marrow, enriched for hematopoietic stem cells (HSC) and graft facilitating cells (FC) and depleted of GVHD-producing cells, will induce tolerance to a donor-specific renal allograft and substantially reduce or eliminate the requirement for chronic nonspecific immunosuppressive agents within 12 months following transplantation. |
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Eligibility |
Inclusion Criteria: 1. Patients must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure. 2. Patient is receiving first renal transplant. 3. Patient is receiving a renal transplant only. 4. Patient has a cadaveric organ donor. 5. The patient's panel reactive antibody (PRA) is < 10% and the crossmatch is negative between donor and recipient. 6. Women who are of child bearing potential must have a negative pregnancy test before TBI and agree to use reliable contraception for 1 year following transplant. |
Exclusion Criteria: 1. Clinically active bacterial, fungal, viral or parasitic infection. 2. Pregnancy. 3. Clinical or serologic evidence of Hepatitis B (HBV), Hepatitis C (HCV) or Human Immunodeficiency (HIV) Virus infection. 4. Malignancy. 5. Previous radiation therapy at a dose which would preclude Total Body Irradiation. 6. Positive crossmatch between donor and recipient. |
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