Trial Will Examine Stem Cell, Drug Delivery System
January 4, 2010 – The FDA's permission is sought to allow a safety and feasibility trial for the PHOENIX System, which allows tissue stimulation and injections of biologic or pharmacologic agents to the myocardium. The system is designed to treat patients with refractory angina.
Cardiogenesis Corp. today said it submitted an investigational device exemption (IDE) with the FDA. The PHOENIX System utilizes the thermoacoustic stimulated tissue zone created by a laser and introduces additional potent, therapeutic agents, including stem cells, into the myocardium to dramatically enhance the healing process.
The PHOENIX includes an integral CrystalFlex fiberoptic component consisting of 37, 100 µm diameter fibers, identical to the fiber optic component currently in use in the FDA approved Sologrip III and PEARL 5.0 hand pieces. The hand piece has been modified to include three 26-gauge needles positioned around the fiber optic fibers, which allow precise delivery of fluids, including stem cells, into the tissue surrounding the channels created by the fiber optic.
"To date I have successfully treated 18 patients utilizing the PHOENIX with bone marrow derived stem cells,” said Dr. Guillermo Reyes, department of cardiovascular surgery, Hospital Universitario La Princesa, Madrid, Spain. “These were patients with severe angina and not candidates for coronary bypass or percutaneous intervention. At follow up, all of the patients improved by at least two classes of angina, and one-half were angina free. Based on the published literature and my own experience, laser channeling has proven to be a valuable clinical option. This preliminary study suggests the addition of stem cells is synergistic and this combination therapy offers the potential to improve clinical results and expand the utility of this approach."
These results build upon the in vivo research demonstrating that PHOENIX increased stem cell survival in targeted heart muscle when compared to direct injection alone.
For more information: www.cardiogenesis.com