Date: 2016-11-22
Type of
information: Interim results
phase: 2
Announcement: interim results
Company: co.don (Germany)
Product: co.don chondrosphere® (ACT3D-CS)
Action
mechanism: cell therapy.
Disease: cartilage defects of the knee
Therapeutic
area: Bone diseases - Regenerative medicine
Country: Germany
Trial
details: This prospective, randomised, open label, multicentre Phase II clinical trial is investigating the efficacy and safety of the treatment of large defects with 3 different doses of the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) in subjects with cartilage defects of the knee.
After screening visit patients were booked for arthroscopy and had their cells harvesting from healthy cartilage. After the arthroscopy the patients were randomised in one of the three dose-groups. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional spheroids, that are transplanted in an open knee procedure (treatment surgery)into the defect. Patients of all dose groups subsequently followed the same rehabilitation program and had post-surgery visits. The 12-month-visit is defined as final assessment. Then patients have follow-up assessments up to 60 months. (NCT01225575)
Latest
news:
- • On November 22, 2016, co.don AG has received further interim results from the Phase II clinical trial "co.dis", which demonstrate the safety and therapeutic benefits three years after treatment. In the long-term clinical study 75 patients aged between 18 and 50, with cartilage defects in the knee of 4 to 10 cm2, were treated with the autologous matrix-associated chondrocyte implants co.don condrosphere® in various dosages. Results of the KOOS and MOCART scores have now been analysed three years after treatment. The KOOS score is a subjective metric that reflects the patient's own assessment of categories including: Knee-related statement on quality of life, knee function in sport and leisure and pain. The MOCART score shows the clinical success of the treatment using MRT images.
- The results confirm the lasting and significant improvement compared with the status quo before treatment. In particular, the therapy is also effective for defects which are comparatively difficult to treat. So cartilage defects on the back of the kneecap were treated with above-average success.
- Currently co.don AG is conducting another multi-centric, prospective, randomised open-label Phase III trial in line with the internationally acknowledged Good Clinical Practice (GCP) standards, which has also been in the follow-up observation period since December 2014.
- These trial data strongly support co.don to meet regulatory requirements of the European Medicines Agency (EMA) to obtain EU marketing authorisation. The company anticipates EU market approval in the fourth quarter 2017. Co.don has held sales approval for the German market for many years.
Is
general: Yes
