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Prospective, randomised, open label, multicentre Phase II clinical trial to investigate the efficacy and safety of the treatment of large defects (4-10 cm2) with 3 different doses of the autologous chondrocyte transplantation product co.don chondrosphere (ACT3D-CS) in subjects with cartilage defects of the knee

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Trial Profile

Prospective, randomised, open label, multicentre Phase II clinical trial to investigate the efficacy and safety of the treatment of large defects (4-10 cm2) with 3 different doses of the autologous chondrocyte transplantation product co.don chondrosphere (ACT3D-CS) in subjects with cartilage defects of the knee

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Jan 2024

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At a glance

  • Drugs Autologous cultured chondrocytes (Primary)
  • Indications Knee injuries
  • Focus Registrational; Therapeutic Use
  • Sponsors co.don AG
  • Most Recent Events

    • 01 Dec 2023 According to a ReLive Biotechnologies media release, the company has received New Drug Application (NDA) approval for SpheChon 10-70 spheroids/cm2 in December 2023 by the Health Sciences Authority (HSA), Singapore.
    • 16 Apr 2018 New trial record
    • 05 Apr 2018 According to the co.don AG media release, interim results collected annually over the four-year follow-up period and five-year follow-up examination was carried out for the last patient in early 2018, which was followed by final statistical analysis and evaluation.

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