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Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016, allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute traumatic spinal cord injury

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Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016, allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute traumatic spinal cord injury

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 07 Sep 2023

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At a glance

  • Drugs FAB 117-HC (Primary)
  • Indications Spinal cord injuries
  • Focus Adverse reactions; First in man
  • Acronyms SPINE
  • Sponsors Ferrer

    • Most Recent Events

    • 08 Sep 2021 Planned End Date changed from 1 Mar 2022 to 1 Jul 2023.
    • 08 Sep 2021 Planned primary completion date changed from 1 Oct 2021 to 1 Jul 2022.
    • 03 Oct 2019 Planned number of patients changed from 46 to 48.

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