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Tag: stromal vascular fraction

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

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Yesterday, October 27th, the Feds filed a notice of appeal of Judge Jesus Bernal’s decision awarding Cell Surgical Network and their founders, the late Mark Berman and Eliot Lander, judgment in the FDA’s attempt to shut them down for their SVF (stromal vascular fraction) stem cell treatment. Of course, the feds were going to appeal. Contrary to the Florida district court and the Eleventh Circuit in the US Stem Cell case, Judge Bernal found that SVF was not more than…

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For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

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If you are in the business of providing autologous stem cell transplants during the same surgical procedure for therapeutic purposes, the next couple of months are going to be very consequential for you because of the decisions in the two big cases in the field. The appeal of the US Stem cell case is now under consideration by the appellate court. Oral argument was held on January 13th. By some accounts, the judges gave the government a hard time. But…

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The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

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In late August, the FDA issued a trilogy of pubic actions and announcements advancing its goal of shutting down what I’ll call the practice of medicine stem cell clinics (“POM”). These clinics provide autologous stem cells and other autologous tissue or tissue based products which have not been approved by the FDA. These clinics have exploded in popularity over the past dozen years, which has caused the FDA and the stem cell institutional players much angst. The FDA’s efforts to…

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