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FDA: Local stem-cell research clinic must stop providing pain treatments

The Food and Drug Administration (FDA), citing regulation of a "cultured cell product," is seeking an injunction against Broomfield-based Regenerative Sciences, LLC for its use of stem cells to treat patients' pain, a procedure they have trademarked as Regenexx.

Medical director Christopher Centeno, MD denies the FDA's claims and welcomes the court fight with the FDA so he can prove the clinic "[is] not a drug manufacturer, but simply a medical practice."

The issue is whether cultured stem cells, taken from a patient and grown in the lab, can then be injected into the same patient in order to alleviate pain. The FDA says the practice is illegal: the cultured cell product, they argue, should be tested and labeled as a drug, and since the FDA has not conducted studies regarding efficacy or risks, the drug product can not be used.

John Schultz, M.D., a fellow founder of the Centeno-Schultz Clinic, claims the analogy is flawed and the cultured cells are not manufactured drugs: "What we're doing in our Colorado medical practice is no different, in principle, than a fertility clinic that uses the in-vitro fertilization technique. The only difference is that we're using stem cells and fertility clinics use fertilized eggs."

Drs. Centeno and Schultz are innovators in the stem-cell research field; recently, they co-authored a study which appeared in Current Stem Cell Research & Therapy. For its part, the FDA notes it does not want to discourage innovation, but that it must keep the public's safety in mind.

Until the litigation has been resolved, Regenerative Sciences has agreed to halt use of stem cells in treating pain.

Comments

  • Anonymous 3 years ago

    interesting

  • Dr. J 3 years ago

    This is a travesty. This clinic is doing excellent work, follows safe and ethical standards and publishes their findings. Dr. Centeno is one of the clinical pioneers in this field and a very ethical doctor. The FDA should consider working with him in gathering clinical data, not against him to satisfy the greed/controlling interest of the drug companies. These are people's own stem cells that are being re-injected and expanded. What a wonderful approach instead of relying on drugs for pain and disability.

    Dr. J

  • Anonymous 3 years ago

    I have personally been treated by Dr. Scholz, and although I find him a competent doctor I feel that their pioneering research is not for the benefit a patient but motivated by the almighty dollar. I feel this clinic is reckless and motivated by money, which makes them a danger to their patients. There is very little documented data supporting their techniques, I support what the FDA has done and feel they have public safety in their best interest.

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