CRO inVentiv Health Clinical has been selected for an osteoarthritis Investigational New Drug application (IND) by regenerative medicine biotechnology company IntelliCell BioSciences. IntelliCell will be studying the use of adult autologous vascular cells from blood vessels in adipose tissue to treat osteoarthritis of the knee.
Principal Investigator James Andrews is an orthopedic surgeon known internationally for his scientific and clinical research into knee, shoulder and elbow injuries. Andrews is a founding member of the American Sports Medicine Institute and founding partner and medical director at the Andrews Institute in Gulf Breeze, Fla. inVentiv Clinical will work with Andrews to develop investigational clinical study protocols and will be the CRO on trials conducted at the Pensacola Center of the Andrews Institute.
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 U.S. 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.