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A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Traumatic Brain Injury (TBI)

Trial Profile

A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Traumatic Brain Injury (TBI)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Vandefitemcel (Primary)
  • Indications Traumatic brain injuries
  • Focus Therapeutic Use
  • Acronyms STEMTRA
  • Sponsors SanBio
  • Most Recent Events

    • 12 Feb 2025 According to a SanBio media release, the interim analysis results published in the online edition of Neurotrauma Reports
    • 12 Feb 2025 The interim analysis results published in the SanBio media release
    • 31 Jul 2024 According to a SanBio media release, company obtained conditional and time-limited marketing approval for the human somatic stem cell-processed product AKUUGO suspension for intracranial implantation in Japan, for the indication of improving chronic motor paralysis resulting from traumatic brain injury based on results this trial.

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