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news.IntelliCell BioSciences, a regenerative medicine company utilizing adult autologous stomovascular cells (SVCs) derived from the blood vessels found in adipose tissue, has filed its pre-IND with the FDA for a clinical trial in osteoarthritis of the knee under an Investigational New Drug Application (IND).
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Dr. James Andrews, the legendary orthopedic surgeon will be the principal investigator for the study. inVentiv Health Clinical will serve as the Clinical Research Organization (CRO) for the conduction of this clinical trial in osteoarthritis of the knee in accordance of an Investigational New Drug.
IntelliCell BioSciences and Dr. James Andrews are developing the investigational clinical study protocols in collaboration with inVentiv Clinical, functioning as the CRO.
The clinical trial will be conducted at the Pensacola Center of the Andrews’ Research and Educational Institute in conjunction with Dr. Adam Anz and Dr. Josh Hackel, prominent physicians at the Institute.
To date, IntelliCell’s technology for isolating stromal vascular fraction cells from the vasculature of adipose tissue has been used to successfully treat over 60 knees with results lasting as long as 5 years.
IntelliCell’s Chief Executive Officer, Dr. Steven Victor, remarked, "This is a pivotal point for IntelliCell BioSciences as it will be what we believe to represent the first of many clinical trials that the company will undertake and establish the company as a leader in the cellular therapy segment of the biotech industry. This IND study is important for verifying the company’s patented technology of utilizing Ultrasonic Cavitation as a method of separating stromal vascular fraction cells from lipoaspirate. We believe that IntelliCell’s Stromal Vascular Fraction Cells will offer people with OA a new and improved approach to gaining significant improvements in their qualities of life. We at IntelliCell are excited to have this opportunity to work with the distinguished Sports Medicine Orthopedic Surgeon, Dr. James Andrews, who will be the principal investigator of this clinical trial."
According to Raymond Hill, President of inVentiv Clinical, "inVentiv Clinical has extensive therapeutic experience in general pain and osteoarthritis programs and a focus on partnering with innovative bioscience companies. We are looking forward to our working with Dr. Andrews and contributing to advances in the treatment of osteoarthritis in knees."
Dr. James Andrews said, "We are excited that we will have the opportunity to work with inVentiv Clinical Health as the CRO for our IND study of osteoarthritis of the knee using IntelliCell’s technology. It will be research like this at the Andrews’ Research and Educational Institute in collaboration with IntelliCell BioSciences and inVentiv that will further our research in the use of the biologics for the treatment of the osteoarthritic knee. We believe, based on antidotal evidence of others, that this cellular therapy has the potential to be a game changer."