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Induction of Donor Specific Tolerance in Recipients of Kidney Allografts by Donor Bone Marrow Cell Infusion


Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Deceased Donor Kidney Transplant

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Trial Information

Induction of Donor Specific Tolerance in Recipients of Kidney Allografts by Donor Bone Marrow Cell Infusion


Inclusion Criteria:



- Patients 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 within
48 hours of initiating TBI and agree to use reliable contraception for 1 year
following transplant.

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 be willing to travel here for the
first three months of the protocol so that we can monitor them closely in the early post
transplant period. As long as there is insurance or funding that will cover the cost of
the 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 a kidney transplant.

- Previous radiation therapy at a dose which would preclude TBI.

- Positive crossmatch between donor and recipient and/or prior immunologic memory to
donor.

- BMI >35 or <18.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of bone marrow transplant

Outcome Time Frame:

1, 3, 6, 9, 12, 24 & 36 months

Safety Issue:

Yes

Principal Investigator

Mary Eng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jewish Hospital and St. Mary's Healthcare

Authority:

United States: Food and Drug Administration

Study ID:

20031154

NCT ID:

NCT00498160

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Deceased Donor Kidney Transplant
  • Kidney transplant
  • Tolerance
  • Marrow transplant
  • Death

Name

Location

Jewish Hospital and Institute for Cellular Therapeutics, University of LouisvilleLouisville, Kentucky  40202