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A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors

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Trial Profile

A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2023

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At a glance

  • Drugs FCR 001 (Primary) ; Corticosteroids; Mycophenolate; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOM-1
  • Sponsors Talaris Therapeutics

    • Most Recent Events

    • 14 Aug 2023 According to a ImmunoFree Inc. media release, the company has acquired all right to FCR001 and the sponsorship of the FREEDOM-1 Study. ImmunoFree has assumed all financial and regulatory responsibilities related to this trial. The company oversee all remaining close-out activities and the shutdown of the remaining active FREEDOM-1 phase 3 clinical sites.
    • 16 Feb 2023 Status changed to discontinued, according to a Talaris Therapeutics media release.
    • 07 Nov 2022 According to a Talaris Therapeutics media release, data from the trial was presented at the 2022 American Society of Nephrology (ASN) Annual Meeting.

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