Okyanos Heart Institute CEO Matt Feshbach Congratulates Japan’s Legislators On Stem Cell Bill And Global Regulatory Leadership

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Cardiac Stem Cell Clinic Applauds Japanese Lawmakers For The Passing Of A Bill Aimed At Ensuring Safety In The Practice Of Regenerative Medicine

Matt Feshbach, Matthew Feshbach

Matt Feshbach

The dawn of a new phase in the evolution of medicine has begun.

December 6, 2013 – Matt Feshbach, CEO of Okyanos Heart Institute whose mission it is to bring a new standard of care and better quality of life to patients with coronary artery disease using cardiac stem cell therapy, acknowledges the Japanese legislature for its recent approval of a bill aimed at the treatment of certain chronic diseases using regenerative medicine strategies.

The legislation was passed in Japan on November 20th, 2013. The new regenerative medicine law emphasizes the importance of establishing patient safety in the use of adult stem cell therapies prior to being offered commercially. It also serves to support innovation in stem cell and regenerative medicine therapies by providing a framework by which such technologies may be granted new, limited approval paths for some biologics.

“Japan has taken a leadership position globally for its passage of enlightened legislation for stem cell therapy,” said Feshbach, who recognizes this development as an important milestone in its potential to benefit patients and the field of healthcare.

“We applaud Japan as well as other countries including but not limited to Australia, Singapore, and New Zealand for approving stem cell processing devices and/or biologics (such as stem cells) for use in clinics today,” he added. “This legislation in Japan says that if a stem cell therapy protocol can demonstrate a strong safety profile, physicians have the option to offer it to patients, generally when other standard-of-care interventions have not proven effective and the patients have no other options available to them. Patients will have the choice to use their own stem cells to treat the condition. By tracking the progress of the patients over time, efficacy can be determined and the treatment may become another standard-of-care treatment option available to patients.”

“While this research is important over the long term, adult stem cell therapy is unique in that it takes advantage of the natural mechanisms of a person’s own stem cells to repair the cells, tissues or organs damaged by disease or injury,” stated Feshbach. “The dawn of a new phase in the evolution of medicine has begun.”

Additional countries such as The Bahamas, Panama, Argentina and Jordan have established regulations and legislation designed to both protect patient safety and give access to treatments which have the potential to help unmet needs such as heart failure and other diseases.

Japan represents the second-largest medical market in the world and remains a global leader in both adult stem cell and gene therapy trials. Dr. Shinya Yamanaka, professor and director for the Center for iPS Cell Research and Application (CiRA) at Kyoto University, was awarded a Nobel Prize in 2012 for the discovery of induced pluripotent stem cells (iPS). Click here to read more about the Japanese legislature’s recent stem cell measures.

About Okyanos Heart Institute: (Oh – key – AH – nos)
Based in Freeport, The Bahamas, Okyanos Heart Institute’s mission is to bring a new standard of care and a better quality of life to patients with coronary artery disease using cardiac stem cell therapy. Okyanos adheres to U.S. surgical center standards and is led by Chief Medical Officer Howard T. Walpole Jr., M.D., M.B.A., F.A.C.C., F.S.C.A.I. Okyanos Treatment utilizes a unique blend of stem and regenerative cells derived from one’s own adipose (fat) tissue. The cells, when placed into the heart via a minimally-invasive catheterization, stimulate the growth of new blood vessels, a process known as angiogenesis. The treatment facilitates blood flow in the heart and supports intake and use of oxygen (as demonstrated in rigorous clinical trials such as the PRECISE trial). The literary name Okyanos (“Oceanos”) symbolizes flow. For more information, go to http://www.okyanos.com

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Erika Mangrum
Okyanos Heart Institute
since: 03/2012
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