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Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use) | Clinical Trials | Clareo Health

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

NCT02051673•Talaris Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Key Dates

Last Updated

July 18, 2022

Conditions

Renal Failure

Interventions

Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion

BIOLOGICAL

CAR-T Cell Therapy for Desensitization in Kidney Transplantation

NCT06056102

Kidney TransplantKidney Failure+1 more

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RECRUITING

Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula

NCT06297343

Renal Failure

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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