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A Phase 3, small 30-patient, one-year confirmatory clinical trial in Japanese patients that compares NeoCart to microfracture

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Trial Profile

A Phase 3, small 30-patient, one-year confirmatory clinical trial in Japanese patients that compares NeoCart to microfracture

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2023

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At a glance

  • Drugs Autologous chondrocyte implantation (Primary)
  • Indications Cartilage disorders; Knee injuries
  • Focus Registrational; Therapeutic Use
  • Sponsors Histogenics Corporation; Ocugen

    • Most Recent Events

    • 21 Aug 2023 According to an Ocugen media release, the company plans to initiate the Phase 3 trial in the second half of 2024.
    • 28 Feb 2023 According to an Ocugen media release, company received concurrence from the FDA on this confirmatory Phase 3 clinical trial design and plans to initiate this trial in the first half of 2024.
    • 16 Dec 2022 According to an Ocugen media release, the company plans to file an Investigational New Drug amendment to initiate of this clinical trial in late 2023/early 2024.
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