Induced Immune Tolerance for Kidney Transplantation

[Clark]

http://www.nejm.org/doi/full/10.1056/NEJMc1107841

Induced Immune Tolerance for Kidney Transplantation
John D. Scandling, M.D.
Stephan Busque, M.D.
Judith A. Shizuru, M.D., Ph.D.
Edgar G. Engleman, M.D.
Samuel Strober, M.D.
Stanford University School of Medicine, Stanford, CA
sstrober@stanford.edu
N Engl J Med 2011; 365:1359-1360

 ...In conclusion, the majority of patients were able to discontinue antirejection medications, and all patients had excellent graft function at the last observation point. We are applying the protocol to patients who were mismatched for one HLA haplotype on the basis of the safety profile of the current study.

[Clark]

http://med.stanford.edu/profiles/frdActionServlet?choiceId=showClinicalTrial&&studyId=6408&fid=4152

Combined Blood Stem Cell and HLA Haplotype Match Living Donor Kidney Transplantation

The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone marrow Transplantation are enrolling patients into a research study to determine if donor stem cells given after a living related one Haplotype match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.

Stanford Recruiting Status:  Recruiting
Condition(s):
Kidney Transplantation
Lead Sponsor: Stanford University
Intervention(s):
Procedure: Total Lymphoid Radiation with Donor hematopoietic stem Cell and Kidney Transplant
Phase: N/A
ELIGIBILITY

Health of Volunteers: People with the conditions listed in this trial can participate as controls.
Key Inclusion Criteria:
1. All consenting adult (> 21 years of age) living donor renal transplant recipients at
Stanford University Medical Center who have a one haplotype match donor.
2. Patients who agree to participate in the study and sign an Informed Consent.
3. Patients who have no known contraindication to administration of rabbit ATG or
radiation.
4. Males and females of reproductive potential who agree to practice a reliable form of
contraception for at least 24 months posttransplant.
5.The donor and the recipient must have an identical blood group.
Key Exclusion Criteria:
1. Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
2. History of malignancy with the exception of non-melanoma skin malignancies.
3. Pregnant women or nursing mothers.
4. Serological evidence of HIV, Hepatitis B or Hepatitis C infection.
5. Seronegative for CMV, if donor is seropositive.
6. Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a
platelet count < 100,000/mm3).
7. PRA greater than 20% or demonstration of donor specific antibody (DSA)
8.Prior organ transplantation
9.High risk of primary kidney disease recurrence (i.e.FSGS)
Ages Eligible for Study: 21 years to 60 years
Genders Eligible for Study: Male and Female
PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

CONTACT INFORMATION

Central Contact:
Asha Shori
(650) 736-0245
Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Primary Contact:
Asha Shori
(650) 736-0245
Secondary Contact:
Stephan Busque
(650) 723-5454