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Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)

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ClinicalTrials.gov Identifier: NCT02051673
Expanded Access Status : No longer available
First Posted : January 31, 2014
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
University of Louisville

Brief Summary:
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)

Condition or disease Intervention/treatment
Renal Failure Biological: Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion

Detailed Description:
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
    Enriched Hematopoetic Stem Cell Infusion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patient 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 (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) 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 Granulocyte colony-stimulating factor (G-CSF)
  • No evidence of donor-specific antibody presently or historically

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
  • Evidence for immunologic memory against donor
  • BMI >35 or <18
  • Re-transplant
  • Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV

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): NCT02051673


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of Louisville
Northwestern University
Investigators
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OverallOfficial: Suzanne T Ildstad, MD University of Louisville

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Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT02051673     History of Changes
Other Study ID Numbers: ICT-7392-Compassionate Use
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by University of Louisville:
Kidney Transplantation

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases