Is it drug manufacturing or the practice of medicine? Stem cell therapy debate just getting started

The latest round of a stem cell debate may have concluded, but as far as the lawyers representing an orthopedics company that has offered stem cell treatments are concerned, its a long way from over.

The lawyers representing Colorado-based Regenerative Science said they were filing a notice of appeal this week after a U.S. District Court judges ruling in favor of the U.S. Food and Drug Administration that its stem cell therapy is a drug. The case is being closely watched by everyone with a stake or an interest in the use of stem cells in medicine and could have significant ramifications for stem cell entrepreneurs who dont believe their procedures amount to a drug or biologic.

Regenerative Science

Colorado-based Regnerative Sciences Regenexx procedure is presented as an alternative to traditional surgery that can treat fractures that have failed to heal, joint cartilage problems, partial tears of tendons, muscles, or ligaments, among other problems. It works like this: A physician takes a small bone marrow sample from the back of the patients hip through a needle. Blood samples are taken from a vein in the patients arm. The samples are sent to the Regenerative laboratory where the mesenchymal stem cells are isolated from the bone marrow and grown to greater numbers using growth factors in the patients blood. The stem cells are injected back into the relevant area in the patient.

The FDA initially sent a warning letter to Regenerative in 2008 after seeing its website. The company turned around and sued the FDA, and two years ago the FDA sought an injunction to shut it down.

The companies that occupy the stem cell treatment landscape are as diverse a group as you could hope to find in medicine. Some offer age-defying beauty solutions, others provide life-saving technology, others have quality-of-life-improving treatments for joints and muscles. There are entrepreneurs leading startups and Big Pharma companies too.

In 2010, the stem cell therapy market was $139.6 million and it was projected to grow to $1 billion by 2015, according to data compiled by Robin Young, the publisher of Orthopedics Week and the CEO of medical data mining company PearlDiver Technologies.

This is on the very cutting edge of medicine and the FDA needs to move forward with it by making sure they have the best information on this science available to inform their decision-making,said Michelle Hart Yeary, counsel with Decherts life science practice.

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Is it drug manufacturing or the practice of medicine? Stem cell therapy debate just getting started