Dr. James Andrews, Respected Orthopedic Surgeon and Founding Member of American Sports Medicine Institute, To Serve as Principal Investigator
BURLINGTON, Mass. – April 15, 2014 – inVentiv Health Clinical, a leading global supplier of drug development services, announced today that it has been selected for an osteoarthritis Investigational New Drug Application (IND) by the innovative regenerative medicine biotechnology company IntelliCell BioSciences, Inc., (OTCQB:SVFC). IntelliCell will be studying the use of adult autologous vascular cells from blood vessels in adipose tissue to treat osteoarthritis of the knee.
The principal investigator is Dr. James Andrews, an orthopedic surgeon known internationally for his scientific and clinical research into knee, shoulder and elbow injuries. Dr. Andrews is a founding member of the American Sports Medicine Institute, author of numerous scientific articles and books and founding partner and medical director at the Andrews Institute in Gulf Breeze, Florida.
inVentiv Clinical will work with Dr. Andrews to develop investigational clinical study protocols and will serve as the Clinical Research Organization (CRO) on trials conducted at the Pensacola Center of the Andrews Institute.
IntelliCell’s technology for isolating stromal vascular fraction cells from the vasculature of adipose tissue has been used to treat more than 60 knees. IntelliCell’s Chief Executive Officer, Dr. Steven Victor, said this is what we believe will be the first of several clinical trials for the biotech company studying the use of its technology in treating a variety of diseases and conditions.
“inVentiv Clinical has extensive therapeutic experience in general pain and osteoarthritis programs and a focus on partnering with innovative bioscience companies,” said Raymond Hill, President of inVentiv Health Clinical. “We are looking forward to our work with Dr. Andrews and contributing to advances in the treatment of osteoarthritis in knees.”
inVentiv Health Clinical offers clients a full range of clinical research services supported by a global infrastructure, therapeutic expertise, and unmatched commitment to quality. For pharmaceutical, biotechnology, generic drug, and medical device companies, inVentiv conducts Phase I-III clinical trials, Phase IV late stage post-approval programs, as well as offering staffing, bioanalytical and regulatory services.
IntelliCell’s IND study will focus on proving the company’s patented technology of Ultrasonic Cavitation as a method of producing stromal vascular fraction cells as a new approach and improvement on current treatment which in the worst cases can involve surgery.
About 75% of people over 70 years of age show changes consistent with osteoarthritis and symptoms such as pain, joint stiffness and joint deformities. Osteoarthritis affects more than 25 million people in the United States alone.
Regenerative medicine is the process of replacing or regenerating human cells, tissues or organs to restore or establish normal function by replacing damaged tissue and/or by stimulating the body's own repair mechanisms to heal previously irreparable tissues or organs.
IntelliCell is planning an in-human clinical trial in late 2014 to study if the IntelliCell vascular fraction cells may demonstrate measurable benefits for patients suffering from this debilitating condition.
About inVentiv Health inVentiv Health, Inc. is 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. With more than 12,000 employees supporting clients in 70 countries, our global scale and broad expertise make us an attractive strategic partner for companies seeking to get medicines to patients in a complex operating, regulatory and reimbursement environment. inVentiv Health’s clients include more than 550 life sciences companies, including all 20 of the largest biopharmaceutical companies in the world. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. inVentiv Health transforms promising ideas into commercial reality for the financial success of our clients and the delivery of better treatments to patients worldwide. For more information, visit www.inVentivHealth.com
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.