St. Petersburg Surgeon Dr. Christian Drehsen Lobbies FDA to Speed Approval of Non-Embryonic Stem Cell Therapy

St. Petersburg, FL (PRWEB) April 17, 2014

One of the most respected plastic surgeons in America is encouraging the FDA to move forward on approval of stem-cell based therapies inspired in part by Matthew McConaughey's recent Oscar win for the film Dallas Buyers Club. In the film, McConaughey portrayed Ron Woodroof, who fought the Food and Drug Administration over his use and distribution of unapproved but effective HIV/AIDS medications. In a letter to FDA comissioner Margaret A. Hamburg dated April 14th, Dr. Christian Drehsen of St. Petersburg claims that the story echoes current FDA treatment of stem cell therapies, of which almost none are approved for use in the United States.

Drehsen cites his extensive past experience working with stem cells, and calls on the FDA to provide more rapid approval for the procedures, which he says are safe and effective.

In the period 2009-2010, before the current regulatory embargo, Drehsen performed over 20 reconstructive and cosmetic stem-cell procedures using technology from the pioneering stem cell therapy research firm Cytori. In his letter, Drehsen writes that the results of his procedures were excellent, and hes frustrated with the limitations now in place.

Japan has approved these procedures. Much of Europe has approved them. Theyre changing peoples lives every day but not in the United States, the letter reads in part.

Stem cell therapies have myriad potential uses. Drehsen says that in his own practice at the Clinique of Plastic Surgery, their promise includes greatly improved outcomes for burn victims, patients with extensive sun exposure damage, and post-operative breast reconstruction procedures. Those therapies have been pioneered with good results in Europe and Australia, respectively.

Other treatments currently proven or under trial include treatments for traumatic hamstring injury (http://ir.cytori.com/investor-relations/News/news-details/2014/Cytori-to-Initiate-US-Clinical-Trial-of-Adipose-Derived-Regenerative-Cells-in-Hamstring-Injuries/default.aspx) and chronic heart failure (http://www.cytori.com/Innovations/ClinicalTrials/CardiovascularDisease.aspx).

Though much American resistance to stem cell research has been rooted in ethical concerns about the use of embryonic stem cells, the Cytori procedure uses Adipose-Derived Regenerative Cells, or ADRCs stem cells derived from the patients own body fat and altered for re-injection using a proprietary process. Dr. Drehsen was one of a handful of doctors in the United States to use this technology for plastic surgery before the FDA blocked its usage. This makes him one of the most experienced surgeons in the U.S. in non-embryonic stem-cell enhanced facelift procedures. Drehsens website (http://cliniqueps.com) features many examples of his past successful stem-cell procedure outcomes.

The FDA serves the vital function of ensuring patient safety. But these procedures have been proven safe," Drehsen concludes. "It should be no surprise that using a patients own tissue presents fewer risks than many alternatives. Its sad that these options have continued to be blocked by bureaucracy.

Drehsen says that much of the equipment used in his stem cell procedures now sits in storage, unused.

Originally posted here:
St. Petersburg Surgeon Dr. Christian Drehsen Lobbies FDA to Speed Approval of Non-Embryonic Stem Cell Therapy

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