ChondroCelect: which tox species, and why?

“Non-clinical studies were performed as combined pharmacodynamic / pharmacokinetic (distribution) / toxicological studies in the ectopic mouse (nu/nu model) and in orthotopic models in sheep and goats.”

“orthotropic animal model showed that implantation of human or allogeneic chondrocytes causes an immune response to the CBMP, resulting in poor repair.”

“In goats ChondroCelect-like chondrocytes showed a more stable cartilage forming potential than dedifferentiated chondrocytes.”

“the observation period of the single dose studies described above were up to 12 weeks in mice, 14 weeks in sheep and 53 weeks in goats”

“Taking into account the nature of the product and its intended clinical use the risk for reproductive and developmental toxicity is considered to be negligible.”

“In view of these results, the absence of standard carcinogenicity studies was considered to be acceptable.”

“In goats ChondroCelect-like chondrocytes showed a more stable cartilage forming potential than dedifferentiated chondrocytes.”