Warning issued to company for selling unapproved stem cell products
A warning has been issued to Stemell for manufacturing and distributing unapproved products derived from umbilical cord blood.
Stemell, Inc. (Stemell) in California and its president and Chief Executive Officer, Peyman Taeidi, PhD have been warned by the US Food and Drug Administration (FDA) for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord.
They have also been warned for significant deviations from current good tissue practice (cGTP) and current good manufacturing practice (cGMP) requirements, including deficient donor eligibility practices and environmental monitoring. This could create potential significant safety concerns that put patients at risk.
Stemell’s unapproved products derived from umbilical cord blood and umbilical cord are StemL UCB-Plus and StemL UCT-Plus.
This company failed to take appropriate measures to protect patient safety.
“Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients,” said Acting FDA Commissioner Ned Sharpless, MD.
The FDA’s recent inspection of the Stemell facility revealed that the company was manufacturing products derived from human umbilical cord blood and umbilical cord for use in recipients unrelated to the donors of the products. Because these Stemell products are not intended for homologous use only and fail to meet other criteria set forth in applicable FDA regulations, they are regulated as both drugs and biological products.
To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for these Stemell products.
During the inspection, the FDA documented evidence of significant deviations from cGTP and cGMP requirements in the manufacture of Stemell’s products, including deficient donor eligibility practices, unvalidated manufacturing processes, deficient environmental monitoring and inadequate aseptic processes.
These deviations pose a risk that the products may be contaminated with viruses or microorganisms or have other serious product quality defects.
The FDA has requested a response from Stemell, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.