Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation

Samsung Medical Center

Status: Unknown

Conditions: End Stage Renal Disease

Treatments: Procedure: Transplantation Conditioning for BMT

Study type: Interventional

Funder types: Other

Identifiers

NCT02199301

2010-07-210

Details and patient eligibility

About

Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been well-known that long-term IS inevitably causes various complication e.g. infection, toxicity, diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and malignancies and so on. Tolerance induction showing graft function without maintenance IS has been considered as a final solution in the transplantation recipients. Tolerance induction can be achieved in KT recipients with donor hematopoietic stem cell transplantation (HSCT).

In this study, adult patients (18 and more years of age) with a human leukocyte antigen (HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for HSCT 1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the time of nephrectomy for transplantation in donor. Donor BM is infused immediate post-transplantation at intensive care unit (ICU). Immunologic measurements including microchimerism study and protocol biopsy will be followed at several time points. IS will be tapered slowly and withdrawn over a period of several months.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All consenting adult (18 and more years of age) living donor kidney transplant recipients who have a one haplotype match donor.
2. Patients who have no known contraindication to administration of rabbit anti-thymocyte globulin (ATG) or radiation.
3. Patients who agree to participate in the study and sign an Informed Consent.

Exclusion criteria

1. Presence of previous episode of transplantation including kidney
2. Simultaneous multi-visceral transplantation
3. Demonstration of donor specific antibody (DSA) or panel reactive antibody(PRA) greater than 20%
4. ABO blood type incompatible
5. Previous treatment with rabbit anti-thymocyte globulin or a known allergy to rabbit proteins.
6. History of malignancy with the exception of non-melanoma skin malignancies.
7. Uncontrolled systemic or concomitant unstable infection
8. Serological evidence of Hepatitis B or Hepatitis C or HIV infection.
9. Severe psychiatric disease
10. Leukopenia (with a white blood cell count < 3000/mm3)
11. Disagreement to participate in the study and sign an Informed Consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

BMTKT

Experimental group

Description:

Transplantation Conditioning for bone marrow transplantation (BMT) Kidney transplantation and BMT (BMTKT)

Treatment:

Procedure: Transplantation Conditioning for BMT