Berlin / Teltow / Leipzig, November 09.11.2020th, 5 - The 2-year follow-up confirms the 16-year final evaluation of the multicentre, prospective, randomized, controlled phase III study co.wisi (cod13 HSXNUMX) with the autologous cartilage cell transplant in terms of efficacy and safety of the Method.
In comparison with the results of the comparator therapy, continuously better clinical results are shown in the areas of "Activities of daily living" (24-60 months after treatment), "Sports and leisure time" (36-60 months after treatment) and "Quality of life in connection with the affected knee” (60 months after treatment). The primary objective of the study, the non-inferiority of the autologous cartilage cell transplant compared to the comparator therapy - microfracture - could be proven with the help of clinical scores and imaging (MRI).
A total of 102 patients with defined defect locations and sizes in the knee cartilage were randomized in 11 study centers. The analysis now available is based on data from the so-called KOOS Score, a clinical score that statistically records self-assessments by patients of possible limitations caused by knee cartilage defects. In addition, an improvement for the patients treated with autologous cartilage cell transplants was also proven by means of imaging methods (MRT).
dr Christian Kaps, Vice President Scientific Affairs: “We are very pleased that the primary study objective was confirmed even after 5 years of follow-up, because it once again strengthens the clinical evidence of our EU-wide approved drug. At this point, I would like to thank everyone involved in the study centers, who have made a significant contribution to this success through careful data collection over a long period of time.”
CO.DON AG develops, produces and sells endogenous cell therapies for the minimally invasive repair of cartilage defects. The drug offered is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint using only the body's own cartilage cells. The method offered by CO.DON is currently used in over 200 clinics in Germany and has already been used in over 15.000 patients. CO.DON received EU-wide approval for this drug in July 2017, and approval for Switzerland in March 2019. At the Leipzig site, CO.DON built one of the largest plants for the production of human cells on an industrial scale for in-house and contract production. The shares of CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Board of Directors of the company: Tilmann Bur.
For more information, please visit www.codon.de.
Source: Press release from CO.DON AG dated November 9.11.2020th, XNUMX