FDA ISSUES WARNING LETTER TO MAKER OF "STEM CELL" PRODUCT

The U.S. Food and Drug Administration (FDA) has warned Genetech, Inc. of San Diego, CA for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients.  Genetech processed umbilical cord blood from into unapproved human cellular products, which was distributed by Liveyon, LLC.  

Genetech, and other similar companies, take donated human umbilical cord blood from woman giving birth and they process the blood, allegedly to extract the stem cells and growth factors.  The final product is then packaged and marketed to physicians and clinics.  In the case of Genetech, the product sold by Liveyon is marketed as containing viable stem cells.  However, independent testing has verified that Liveyon contains NO live viable stem cells.  In fact, there is NO commercially available product that contains ANY live viable stem cells.  Period.  The FDA is also sending letters to other firms and providers offering stem cell treatments notifying them of agency’s regenerative medicine policy framework.

Patients need to be educated on this last point because an increasing number of questionable "stem cell" clinics are marketing "stem cell" treatments involving the use of amnion, placenta, or cord blood-derived products.  Such claims are not only completely fraudulent but also a violation of FDA regulations.

While orthobiologic products derived from human placenta, amniotic fluid/membrane, or cord blood CAN have therapeutic benefit (and here at the New England Stem Cell Institute we use some of these products very judiciously), they are NOT "stem cell" treatments.  Currently the only FDA cleared stem cell treatments are those that use the patient's OWN stem cells, and only when processed according to approved FDA guidelines.

You can be fully assured that EVERYTHING we do here at the New England Stem Cell Institute complies fully with FDA guidelines, and we will NEVER do anything that puts our patients' health, and our reputation, at risk.

Full story:  

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628918.htm

 

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