ViaCell gets IDE supplement OK for ViaCyte pivotal trial

US firm ViaCell says that it has received Food and Drug Administration approval of its investigational device exemption (IDE) supplement for its ViaCyte pivotal clinical trial. The study will evaluate the agent, an investigational product being assessed for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology.

FDA approval of the IDE supplement allows the company to enroll women into the study and commence in vitro fertilization treatment, or IVF. Previously, the agency disapproved the IDE supplement. In doing so, the FDA asked ViaCell to respond to questions related to the specifications and sourcing of certain raw materials used in the manufacturing of the ViaCyte media. All questions have been addressed and no conditions are outstanding.

"We are extremely pleased we resolved this issue with the FDA," said Karen Nichols, vice president, regulatory affairs and quality systems at ViaCell. "We can now begin treatment of women previously consented to participate in the ViaCyte pivotal trial and we expect our US sites to advance enrollment. We continue to expect to complete the trial in 2009," she added.