ChondroCelect: what was done before first-in-human, and what came after?

“The dose selection was based on a combination of animal studies conducted by TiGenix, published literature and experience in humans with ACI.”

“As 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, these studies are considered to be sufficient to assess the long-term effects of ChondroCelect.”

“These studies were non-GLP which is not in conformity with the pharmaceutical standards.”

“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.”

“the omission of reproductive and developmental toxicity studies in the development program for ChondroCelect is acceptable”

“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 order to address the carcinogenic potential of ChondroCelect, the Applicant performed an in vitro study to evaluate senescence of human articular chondrocytes after serial passaging, using ChondroCelect culture conditions.”

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