IntelliCell completes registration of New York cell processing facility PBR Staff Writer Published 12 November 2012 IntelliCell BioSciences has announced FDA registration of its new cell processing facility in New York, US. The registration allows the recovery, processing, packaging, storage, and labeling of human cells and tissue products (HCT/P's) including the company's autologous stromal vascular fraction cellular product at the new facility. IntelliCell chairman and CEO Dr. Steven Victor said that the new cellular processing facility has now been registered to process an individual's own tissue for the purpose of acquiring their stem and regenerative cells for use in regenerative medicine."The IntelliCell processing technology is designed to allow physicians to treat their patients during a same day and same procedure basis much the same way that bone marrow transplants and IVF treatments are performed today," Dr. Victor added. The facility will operate under 21 CFR 1271.10 HCT/P regulations, similar to autologous tissue transplants. IntelliCell clinical development EVP Robert Sexauer said, "We can now begin to move forward with our plans for in-human clinical studies such as lower limb ischemia by applying to Institutional Review Boards (IRB's) with study protocols and laboratory processes that will be compliant with the federal and state regulations."
Posts
No comments:
Post a Comment