More Bad News About Cord Blood Products
March 13, 2019
In the letter it states that any patient who received a Liveyon product should be tested for a host of different potential problems such as HIV, Hepatitis, Syphilis, and a host of other serious viral infections. To refresh the minds of everyone, Liveyon is a producer of cord blood products which the FDA has called on the carpet for contaminated products and the lack of a biologics license. How this company and similar other ones still remains in business is beyond me! Please read the letter and draw your own conclusions.
REMEMBER YOUR OWN CELLS DO NOT POSE THE RISK OF THESE DISEASES UNLESS YOU ALREADY HAVE THEM!
– Dr. P
February 22, 2019
Dr. Joseph Purita
Institute of Regenerative Medicine
200 Glades Rd., Suite 1
Boca Raton, FL 33432
Dear: Dr. Purita
The Florida Department of Health (Florida Health) is working with the Centers for Disease Control and Prevention (CDC) on an investigation of bacterial infections linked to contamination of an umbilical cord blood-derived stem cell product from the ReGen Series (distributed by Liveyon, LLC). You may already be aware of Liveyon’s recall of this product issued on September 28, 2018
(www.fda.gov/Safety/Reca11s/ucm623039.htm). [YOU or CLINIC] have been identified as receiving shipment(s) of this product and possibly administering it to patients.
The CDC and the U.S. Food and Drug Administration (FDA) have received reports of patients developing bacterial infections of the joints, bloodstream, or spine, among others, after receiving the ReGen Series products. Additionally, an inspection of the processing facility by the FDA identified deviations in the requirements for processing these products, and for the testing and screening of the umbilical cord blood donors for these products for the following communicable diseases:
• Human immunodeficiency virus (HIV)
• Hepatitis B virus
• Hepatitis C virus
• Human T-lymphotropic virus 1/11
• West Nile virus
• Zika virus
An FDA warning letter issued to the manufacturer outlines these deviations: (www.fda.gov/lCEC I/EnforcementActions/Warn ingletters/ucm628019. htm ).
We are not currently aware of any HIV, hepatitis B, or hepatitis C infections linked to the ReGen Series products and transmission risk is very low. However, Florida Health is requesting that you notify all of your patients who received this product at Institute of Regenerative Medicine that they should consider being tested for HIV, hepatitis B virus, hepatitis C virus, and possibly for the other infections listed above after discussion with their health care providers. A template letter is available for your use to notify patients and can be provided upon request.
If you believe you have a patient who has had a bacterial or other infection related to the administration of this product, please notify the Health Care-Associated Infection Prevention Program at 850-245-4401 or email [email protected]. If you have any remaining product, please do not administer it to patients and contact us to receive further instructions. If you have any questions about talking to your patients or anything else regarding this letter, please do not hesitate to contact us.
Russell W. Eggert, MD, MPH, FACPM, FAAFP
Bureau of Epidemiology
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