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A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients

A Single-arm, Multi-center, Exploratory Safety and Efficacy Study of FCR001 Cell-based Therapy to Induce Donor-specific Tolerance in Previously Transplanted Recipients of a Kidney From a Living Donor, and Safety in FCR001 Donors

NCT01649388•Talaris Therapeutics Inc.

View on ClinicalTrials.gov

Summary

An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.

Detailed Description

The purpose of this study is to assess the safety, tolerability, preliminary efficacy, and overall benefit of FCR001 cell therapy in previously transplanted recipients of a kidney from a living donor. FCR001 is a novel, cryopreserved allogeneic somatic cell therapy, derived from mobilized peripheral blood mononuclear cells from the same donor as the allograft, and containing hematopoietic progenitor cells, facilitating cells, and αβ T cells. The rationale is to establish durable chimerism and donor-specific tolerance in the recipient enabling freedom from chronic immunosuppression (IS) and its associated toxicities.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Recipient age ≥18 years old.
•2. Donor age ≥18 and ≤60 years old at the time of signing informed consent.
•3. Recipient of a first kidney transplant from a living donor 3-12 months prior to signing informed consent.
•4. Stable renal allograft function ≥60 mL/min/1.73m\^2 prior to screening (defined as \<25% decrease in eGFR (by Modification of Diet in Renal Disease formula \[MDRD4\]) between the last 2 consecutive visits and per investigator judgment).
•5. Donor between 3 weeks and 12 months after kidney donation, willing to undergo mobilization, apheresis, and 12-month safety follow-up.

Exclusion Criteria

•1. Donor/recipient crossmatch positive at time of living donor kidney transplantation.
•2. Recipient or donor with use of other investigational drugs within 30 days (or within 5 drug half-lives) of signing informed consent.
•3. Recipient or donor with history of hypersensitivity to any of the study drugs or drugs of similar chemical classes.
•4. Recipient and donor who are identical twins.
•5. Pregnant or nursing (lactating) woman.
•6. Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance \[MGRS\], monoclonal gammopathy of unknown significant \[MGUS\]) of any organ system (other than localized excised non-melanomatous lesions of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
•7. Recipient or donor with known bone marrow aplasia.
•8. Multi-organ or cell transplant recipient.
•9. Blood type ABO incompatible with donor.
•10. Positive donor-specific antibody (DSA) at any time pre- or post-transplant (to be confirmed within 30 days prior to FCR001 infusion).
+14 more criteria

Locations (3)

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Key Dates

Start Date

October 15, 2012

Primary Completion Date

February 28, 2023

Completion Date

February 28, 2023

Last Updated

March 2, 2023

Conditions

Kidney Transplantation

Interventions

FCR001

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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: March 2, 2023Data 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.

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A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients

Inclusion Criteria

Exclusion Criteria

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