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

July 15, 2022 updated by: Talaris Therapeutics Inc.
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talaris Therapeutics Inc.

Collaborators

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (ESTIMATE)

January 31, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICT-7392-Compassionate Use

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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