Spherox: how long were the pivotal tox studies?

“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.”