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NCT02051673 Clinical Trial

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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02051673
Other study ID # ICT-7392-Compassionate Use
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date July 2022
Source Talaris Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Talaris Therapeutics Inc. Northwestern University

Country where clinical trial is conducted

United States, 

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