| Protocol Number: |
Version 1.0 9/15/02 |
| Trial Phase: |
Phase I |
| Maximum # of Subjects: |
15 |
| IRB Number: |
WIRB IRB# 1051762 |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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| To determine whether the administration of mobilized peripheral blood or bone marrow, enriched for HSC and graft 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. Subjects must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure.
2. Subject is receiving first renal transplant.
3. Subject is receiving a renal transplant only.
4. Subject has a living organ donor.
5. The subject's panel reactive antibody (PRA) is < or equal to 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, 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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