|By Marketwired .||
|August 1, 2014 01:53 PM EDT||
NEW YORK, NY -- (Marketwired) -- 08/01/14 -- IntelliCell BioSciences, Inc. ("IntelliCell" or the "Company") (OTCQB: SVFC), a regenerative medicine company utilizing adult autologous stomovascular cells (SVCs) derived from the blood vessels found in adipose tissue, announced today that it has filed its pre-IND with the FDA for a clinical trial in osteoarthritis of the knee under an Investigational New Drug Application (IND). 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."
About IntelliCell Biosciences
IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using adult autologous stromal vascular fraction cells (SVFCs) derived from the blood vessels in the adult adipose tissue. IntelliCell BioSciences has developed its own patented technology and protocol to separate adult autologous vascular cells from adipose tissue without the use of enzymes. IntelliCell will also be seeking to develop technology-licensing agreements with technology developers, universities, and international business entities.
About Dr. James Andrews
Dr. James Andrews is internationally known and recognized for his scientific and clinical research contributions in knee, shoulder and elbow injuries, as well as his skill as an orthopedic surgeon.
Dr. Andrews is a founding partner and medical director for the Andrews Institute in Gulf Breeze, Florida. In addition, he is a founding member of the American Sports Medicine Institute (ASMI).
Dr. Andrews has been the mentor for more than 250 orthopedic/sports medicine fellows and more than 45 primary care sports medicine fellows. Involved in education and research in sports medicine and orthopedic surgery, he has made major presentations on every continent, and has authored numerous scientific articles and books.
About Osteoarthritis Arthritis of the Knee
Osteoarthritis (OA) also known as degenerative arthritis or degenerative joint disease or osteoarthrosis, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion. As a result of decreased movement secondary to pain, regional muscles may atrophy, and ligaments may become more lax.
Treatment generally involves a combination of exercise, lifestyle modification, and analgesics. If pain becomes debilitating, joint replacement surgery may be used to improve the quality of life. OA is the most common form of arthritis, and the leading cause of chronic disability in the United States. It affects about 1.9 million people in Australia, 8 million people in the United Kingdom and nearly 27 million people in the United States.
About inVentiv Health Clinical
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. inVentiv Health Clinical is part of inVentiv Health, Inc., a life science knowledge and services company purpose-built for the new healthcare marketplace. inVentiv has created a new model by converging a vast range of essential services to fully align with our client's development and commercialization goals. For more information, visit www.inventivhealthclinical.com.
Certain statements set forth in this press release constitute "forward-looking statements." Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning," "expect," "believe," "will likely," "will reach," "will change," "will soon," "should," "could," "would," "may," "can" or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company's actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company's ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company's limited operating history, the limited financial resources, domestic or global economic conditions, activities of competitors and the presence of new or additional competition, and changes in Federal or State laws. More information about the potential factors that could affect the Company's business and financial results is included in the Company's filings, available via the United States Securities and Exchange Commission.
IntelliCell BioSciences, Inc.
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