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LJ Silver

04/09/15 2:10 PM

#86496 RE: Cosmic Chi #86495

IMO AREF's lab needs to be cGTP compliant. I don't know if Andrews lab are currently compliant or not. I am assuming they are not. If they are not it would be hard to do any study IMO.
LJ

http://ih.advfn.com/p.php?pid=nmona&article=53574402



NEW YORK, July 24, 2012 /PRNewswire/ -- IntelliCell BioSciences, Inc. ("Company") (OTCQB: SVFC) announced today that it has received the results of its independent laboratory audit by Biologic Consultant Group and the audit showed that the new lab at 460 Park Avenue, New York, NY was cGTP compliant.

According to Holly Scott, Senior Consultant, Audits & Regulatory Support for Biologics, Human Tissue, Drug & Dietary Supplement Industries & Clinical Trial Investigations of the Biologic Consultants Group, "Since the initial FDA inspection, Intellicell BioSciences has done everything necessary to demonstrate compliance with the HCT/P regulations 21 CFR 1271, and in my opinion you have now established a higher standard of controls for your autologous SVF product than is usually observed."

According to Intellicell's Chairman/CEO Steven Victor MD, "This is great news and we have worked hard over the past 18 months to design, build and have our new facility FDA cGTP compliant. The FDA Warning Letter March 13, 2011 was on an inspection of the old beta site facility which was in the process of being closed as we moved to our new facility on April 23, 2012. We are proud of all our staff and their hard work and together with our FDA consultants and lawyers we are moving forward with this new and exciting technology."

Sarah Young, Director of Intellicell Biosciences Laboratory stated, "I am thrilled to be part of the Intellicell Bioscience team to advance the science of SVFs. I left Gainesville Florida to join the team in New York because I believed I can be a valuable addition and saw the vision of Dr Victor. The SVF cells will help change the way patients are treated in the future."

Dr. Victor stated, "The field of regenerative medicine especially using the stromal vascular cells that we harvest from the blood vessels in the adipose tissue should be regulated and we believe that the FDA cGMPs of the laboratories are an important part of this. No physician should use any SVF cells that are not processed under strict cGTPs otherwise they are risking the safety of their patients."