| Protocol Number: |
Version 2.0 11/22/2002 |
| Trial Phase: |
Phase I |
| Maximum # of Subjects: |
15 |
| IRB Number: |
WIRB # 1051410 |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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| The purpose of this study is to administer donor bone marrow cells to heart transplant recipients in an attempt to induce donor specific tolerance enabling discontinuation or decrease in the doses of immunosuppressive therapy. |
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Eligibility |
Inclusion Criteria: 1. Subjects must be between the ages of 18 and 70 years and meet the institution's criteria for cardiac transplantation.
2. Subject is receiving a first cardiac transplantation.
3. Subject is receiving a cardiac transplant only.
4. Subject's panel reactive antibody (PRA) is < 40.
5. Women who are of child bearing potential must have a negative pregnancy test before TBI and agree to use reliable contraception for one year following transplant.
6. Subjects is able to give informed consent. |
Exclusion Criteria: 1. Clinically active bacterial, fungal, viral or parasitic function.
2. Pregnancy.
3. Clinical or serologic evidence of Hepatitis B (HBV), Hepatitis C (HCV) or Human Immunodeficiency (HIV) Virus infection.
4. History of malignancy.
5. Previous radiation therapy at a dose that would preclude Total Body Irradiation (TBI).
6. History of splenectomy.
7. Hemodynamic instability which would contraindicate lymphocytopheresis.
8. Subject is unable to give informed consent..
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