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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

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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