WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration or FDA warned Stemell, Inc. for selling unapproved umbilical cord blood and umbilical cord products over concerns that patients might be at risk. The regulator also continues to warn patients of the risk of unapproved stem cell therapy.
The FDA found that Stemell sold stem cell products without the required approval. It made and sold unapproved products derived from umbilical cord blood and umbilical cord such as StemL UCB-Plus and StemL UCT-Plus.
However, the company claims that these products do not fall under the regulatory provisions for drugs and biological products.
The FDA stated that this is not true and said it will be increasing its oversight related to cell-based regenerative medicine.
The warning letter was issued after the FDA's recent inspection of the Stemell facility in March. The inspection revealed that the products manufactured by the company were derived from human umbilical cord blood and umbilical cord for use in recipients unrelated to the donors of the products.
The products were found to have significant deviations from current good tissue practice and manufacturing practice requirements. This poses a risk that the products may be contaminated with viruses or microorganisms or have other serious product quality defects.
The agency noted that the Stemell products failed to meet other criteria as they are regulated as both drugs and biological products. An approved biologics license application is needed to lawfully market these products.
Along with the warning letter to Stemell, the FDA has also sent 20 other letters to manufacturers and health care providers across the country who may be offering unapproved stem cell products.
The regulator has requested a response from Stemell within 15 working days of the letter's issuance on how the deviations noted in the warning letter will be corrected.
US-based Stemell is a regenerative medicine tissue bank specializing in the harvesting, isolation and distribution of umbilical cord cellular and cell-free allograft products.
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