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Delayed Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649388
First Posted: July 25, 2012
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Northwestern University
Regenerex, LLC
Information provided by (Responsible Party):
University of Louisville
  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.

Condition Intervention Phase
Kidney Transplantation Biological: Enriched Hematopoetic Stem Cell Infusion Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delayed Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Level of Donor Chimerism from Enriched Hematopoietic Stem Cell Engraftment [ Time Frame: One month to three years ]
    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: Living Kidney Allograft
Recipients with the need for a living kidney allograft are treated with an enriched hematopoetic stem cell infusion from living donor bone marrow several months after the renal transplant
Biological: Enriched Hematopoetic Stem Cell Infusion
Enriched Hematopoetic Stem Cell Infusion

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Patient must be between the ages of 18 and 65 years
  • The crossmatch is negative between donor and recipient within 30 days of the infusion
  • Potential recipients who are women 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 infusion
  • 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% within 30 days of the FCRx infusion

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 an infusion
  • 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.
  • Patients with impaired organ function, such as left ventricular ejection fraction (LVEF) less than 35% or forced expiratory volume at one second (FEV1), forced expiratory volume (FEV), or diffusing capacity of the lung for carbon monoxide (DLCO) less than 50%, or transaminases greater than 4 times the upper limit of normal will be excluded from participation. Biopsy proven rejection episode.
  • Insufficient funds for bone marrow processing costs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649388


Sponsors and Collaborators
University of Louisville
Northwestern University
Regenerex, LLC
Investigators
Study Director: Suzanne T Ildstad, M.D. University of Louisville
  More Information

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01649388     History of Changes
Other Study ID Numbers: ICT-14900-021012
First Submitted: June 29, 2012
First Posted: July 25, 2012
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Louisville:
Kidney transplant
Delayed tolerance
Marrow/enriched hematopoetic stem cell transplant