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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

Trial Profile

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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