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Thread: Stem Cell Treatment Offered At Oceanside Clinic Despite Controversy In Colorado

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    Stem Cell Treatment Offered At Oceanside Clinic Despite Controversy In Colorado

    Stem Cell Treatment Offered At Oceanside Clinic Despite Controversy In Colorado


    Story comes courtesy of California Watch.

    By Christina Jewett

    Doctors at a Southern California clinic have announced that they are “licensed and trained” to perform a stem cell treatment pioneered by a Colorado group that is being sued by the U.S. Justice Department and Food and Drug Administration.

    The FDA has asked a federal judge to stop the Denver-area doctors from performing a Regenexx procedure, which involves removing stem cells from a patient’s bone marrow, expanding them in a special solution and re-injecting the cells at the site of an injury.

    The federal lawsuit, which was filed in August 2010 and is ongoing, contends that Regenerative Sciences is selling an unapproved product that has not been prepared in a safe manner.

    Physicians from Regenerative Sciences in Colorado have said in court papers that they agreed to stop performing the procedure while the case is argued in court. Attorneys for Dr. Christopher Centeno, director of the Colorado group, and his partners say the FDA lawsuit should be stricken because the procedure constitutes the “practice of medicine,” which is not regulated by the FDA.

    The Health Link Medical Center, an Oceanside clinic, is advertising on its website that as of January, its doctors are “trained and certified” by the Colorado team. For its part, the Colorado clinic lists the Oceanside facility as part of its Regenexx Procedure Network, which also includes clinics in New Jersey, New York and Pennsylvania.

    The Health Link website says the California clinic is the first in the state to be “licensed” to perform the Regenexx procedures by the Colorado team.

    “Their stem cell orthopedics experience is unrivaled and they are physician leaders in stem cell therapy for orthopedic injuries in terms of research presentations, publications, and academic achievements,” the website says.

    The California clinic says its Regenexx services are for patients in chronic pain who are seeking an alternative to surgery.

    Andrew Ittleman, a Miami attorney who is representing Regenerative Sciences, emphasized that the FDA is suing the firm over one procedure that is not being performed in California. Ittleman said the FDA is concerned about the group’s process of adding a growth enhancer to increase the number of stem cells taken from a patient before re-implanting them. He said the California procedure does not include use of the growth enhancer.

    The California treatment, he said, “has very little, if anything, to do with the procedure” that’s subject to the FDA lawsuit.

    Ed Anselmo, manager of the Health Link clinic, also said the California group plans to draw tissue from patients' bone marrow, separate the stem cells and re-inject them at the site of an injury. He said the team will not perform the procedure that involves expansion of patient cells in a solution, which is being done at a Regenexx-licensed Cayman Islands clinic. “You can’t do that in the U.S.,” Anselmo said.



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    http://www.huffingtonpost.com/2012/0...n_1246928.html

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