Delayed Tolerance in Recipients of Living Kidney Allografts by Donor Stem Cell Infusion
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Purpose
This study involves the use of an enriched hematopoetic stem cell infusion (stem cells, produced by the bone marrow) from the same donor who provided the original kidney transplant. This kidney transplant may have taken place months to years previously.
This study involves the use of a combination of an enriched hematopoetic stem cell infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation |
Biological: Hematopoietic Stem Cell Transplant/novel platform technology |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Delayed Tolerance in Recipients of Living Kidney Allografts by Donor Stem Cell Infusion |
- Level of Donor Chimerism from Enriched Hematopoietic Stem Cell Engraftment [ Time Frame: One month to three years ] [ Designated as safety issue: No ]Tests are done at key time points to monitor for donor chimerism by evaluating presence of bone marrow-derived hematopoietic stem cells.
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2030 |
| Estimated Primary Completion Date: | December 2025 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Enriched Hematopoetic Stem Cell Transplant |
Biological: Hematopoietic Stem Cell Transplant/novel platform technology
Bone marrow will be processed via a new technology which will enrich hematopoietic stem cells and graft facilitating cells. Monitoring for chimerism will be done at key time points.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has received a renal transplant only
- The original donor for the patient must be willing to participate in the study and meet all of the donor eligibility criteria
- The crossmatch is negative between donor and recipient
- Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte-Colony Stimulating Factor (G-CSF) and agree to use reliable contraception for 1 year following transplant
- Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF
- No evidence of donor-specific antibody presently or historically
- Panel Reactive Antibody (PRA) less than or equal to 20%
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 within a four hour drive, for the first month of the protocol so that we can monitor them closely in the early post stem cell transplant period. As long as there is insurance or funding that will cover the cost of the stem cell 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 Total Body Irradiation (TBI)
- Positive crossmatch between donor and recipient
- Evidence for immunologic memory against donor
- Body Mass Index (BMI) greater than 35 or less than 18
- Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- Insufficient funds for bone marrow processing costs
Contacts and Locations| Contact: Joseph Leventhal, MD | 312-695-9019 | jleventh@nmh.org |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Amanda Sweeney 312-694-0327 amanda.sweeney@northwestern.edu | |
| Principal Investigator: Joseph Leventhal, MD | |
| Principal Investigator: | Joseph Leventhal, M.D. | Northwestern Memorial Hospital |
More Information
No publications provided
| Responsible Party: | University of Louisville |
| ClinicalTrials.gov Identifier: | NCT01649388 History of Changes |
| Other Study ID Numbers: | ICT-14900-021012, 1R41AI098336-01, KSTC-184-512-12-136 |
| Study First Received: | June 29, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Louisville:
|
Kidney transplant Delayed tolerance Marrow/enriched hematopoetic stem cell transplant |
ClinicalTrials.gov processed this record on May 22, 2013