FDA Sternly Warns Companies Against Selling Umbilical Cord Blood Without Approval

Stem cell therapy is in demand due to its unique ability to treat myriad of illnesses. The unspecialized cells taken out from umbilical cord blood can be transformed for many purposes and is most often misused. Since research is in its nascent stages, the Food and Drug Administration (FDA) has strict guidelines and processes to test the product before granting companies permission to sell them.

Recently, the FDA sent 20 manufacturers and health care providers letters warning them to comply with the agency’s Federal Food, Drug, and Cosmetic Act and the FDA’s regulations regarding the investigation and subsequent approval of products during a set discretionary period to check their safety issues. 

"This period, which ends in November 2020, has allowed product manufacturers time to engage with the FDA to determine if they need to submit a marketing authorization application and, if so, seek guidance on how to submit their application to the FDA for approval. The agency continues to urge these manufacturers to engage with the agency about their regulatory requirements in the coming months,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release.

After a recent inspection, the FDA sent letters addressed to the company heads of Liveyon Labs and Liveyon LLC, reprimanding them for marketing products such as PURE and PURE PRO made from stem cells found in umbilical cord blood. Some of the other companies pulled up were RichSource Stem Cells, Inc., and Chara Biologics, Inc., for selling unapproved stem cell products to medical personnel and patients. 

The federal agency found evidence that current good tissue practice (CGTP) and current good manufacturing practice (CGMP) guidelines set by the FDA had been violated in the manufacturing of PURE and PURE PRO products. 

Some of the violations that could harm the patient were that the donors medical records were not checked for prior infections, poor aseptic techniques were not adopted by not taking the right steps to prevent contamination by pathogens and not having a system in place to disinfect the room and equipment. By not following the correct protocol, defects in these stem cell products could harm the health of the patient. 

The Centers for Disease Control and Prevention (CDC) alerted the FDA about people in Nebraska getting treated with unapproved exosome-containing products, especially in clinics offering illegal stem cell products. The FDA asserted that till date, no exosome products have been given approval for commercial usage and that some clinics are taking advantage of their vulnerable patients. This is currently being investigated, according to the FDA.

The FDA has categorically stated that Liveyon Labs and Liveyon LLC must submit a response within 15 working days of the date mentioned on the letterhead, highlighting the action they plan to implement to correct the violations. If the companies failed to take corrective measures, it could lead to legal consequences. 

stem cell treatment Hundreds of clinics abroad and across the U.S. now offer a variety of stem cell treatments, though without any regulation, it's difficult to say whether they're legitimate options for therapy. Sam Panthaky / Getty