Spherox

“Comparative analyses of chondrocytes from different species showed that only a limited number of animals including Göttinger mini-pig and Merino sheep were capable of producing stable spheroids.”

“These species were then selected for proof-of-concept studies.”

“In these studies, either human Spheroxs or autologous spheroids produced analogously to human Spheroxs were used.”

“The long term effects of the Spherox product cannot be fully evaluated from the in vivo data as the GLP compliant sheep study of 9 months duration failed due to loss of Spherox implants.”

“study Merino sheep was designed to evaluate local and systemic toxicity during 6 months of implantation of autologous spheroids in a femoral condyle defect.”

“In the in vivo studies, a single dose of spheroids was either injected or implanted into a knee joint or administered subcutaneously in the back of the animal.”

“No genotoxicity, conventional carcinogenicity and reproductive- and developmental toxicity studies were performed”

“No genotoxicity, conventional carcinogenicity and reproductive- and developmental toxicity studies were performed”

“Reproductive and developmental toxicity studies were not conducted.”

“Safety pharmacology was not evaluated with Spherox.”

“There were no indications of treatment related adverse effects and the implant was well tolerated.”

“It should be noted that poplietal lymph nodes (lymph nodes draining the knee joint) of two of the animals were enlarged.”

“There were no indications of significant systemic distribution of the cells, or were there any indications of tumour or ectopic tissue formation after 6 months in the tumourigenicity part of this study.”

“migration might also be a potential safety issue if the cells should have a capacity to infiltrate e.g. subchondral bone when implanted in full thickness cartilage defects”