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A Single-arm, Multi-center, Open-label Proof of Concept Safety and Efficacy Study of FCR001 Cell-based Therapy in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis at Risk for Organ Failure

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A Single-arm, Multi-center, Open-label Proof of Concept Safety and Efficacy Study of FCR001 Cell-based Therapy in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis at Risk for Organ Failure

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I/II

Latest Information Update: 16 Oct 2023

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At a glance

  • Drugs FCR 001 (Primary)
  • Indications Diffuse scleroderma
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms FREEDOM-3
  • Sponsors Talaris Therapeutics

    • Most Recent Events

    • 10 Oct 2023 Status changed from active, no longer recruiting to withdrawn prior to enrolment.
    • 15 May 2023 Status changed from recruiting to active, no longer recruiting.
    • 12 May 2022 According to a Talaris Therapeutics media release, the company believe that that positive proof-of-concept data from FREEDOM-3 has the potential to both support the use of FCR001 in scleroderma as well as other severe, systemic autoimmune diseases.

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