The FDA has sent a to Liveyon -- the company featured in the podcast "" -- and a handful of other companies over unapproved stem cell products.
Liveyon was slapped for processing and distributing unapproved products derived from umbilical cord blood, called Pure and Pure Pro, and for deviations from good tissue/manufacturing practices, including poor practices related to contamination prevention and donor eligibility, according to the FDA.
Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a that Liveyon "failed to take appropriate measures to protect patient safety."
An FDA inspection in May found Liveyon was processing and distributing those products for use in patients who weren't related to the donors. Therefore, they aren't intended for "homologous use only" -- performing the same function in the recipient as in the donor -- so they must be regulated as both drug and biological products, the FDA said.
That inspection also found deviation from standard processes, "including deficient donor eligibility practices, such as failing to screen donors' relevant medical records for risk factors for communicable diseases; inadequate aseptic practices, such as failing to follow procedures to prevent microbiological contamination; and deficient environmental monitoring, such as failing to establish a system for cleaning and disinfecting the processing room and equipment."
FDA said those deviations "pose a significant risk that the products may be contaminated with viruses or other microorganisms or have other serious product quality defects, which could potentially lead to patient harm."
An approved biologics license application (BLA) would be needed to market the product, and an investigational new drug (IND) application would be required to run human trials; Liveyon has neither for its Pure and Pure Pro products, FDA said.
The agency gave Liveyon 15 working days to address how those deviations will be corrected, otherwise it can take action such as seizure, injunction, or prosecution.
"" takes a deep look into an instance last year in which after getting contaminated stem cell injections sourced from umbilical cord blood -- which were manufactured by Genetech and distributed by Liveyon.
Liveyon CEO John Kosolcharoen granted reporter Laura Beil an extensive interview that offered insights into the current business of stem cell therapy, which the FDA has long been trying to wrangle.
In November 2017, the FDA issued its for regenerative medicine products, and gave stem cell clinics 3 years to come into compliance with FDA regulations. Until the November 2020 deadline, companies can engage with FDA to determine if they need to submit a marketing authorization application for their products.
Yet questionable stem cell therapies remain available to patients, and 鶹ý conducted an investigation into a potential source of those therapies: placenta donation programs that more hospitals are now implementing.
Until next year's deadline, FDA said it's applying a risk-based approach to compliance and enforcement for those cell-based regenerative medicine products, which takes into account how the products are administered and the conditions they're intended to treat.
Compliance with the regulations has been questionable, "as evidenced by the number of actions that the agency has taken this month alone," said Marks in FDA's statement on Liveyon.
Indeed, in addition to the Liveyon warning, FDA sent letters to and for offering unapproved stem cell products to patients. That was on top of another 20 letters FDA has sent to manufacturers and healthcare providers about offering those unapproved products, where it reiterated its compliance and enforcement policy.
The FDA has asked physicians and healthcare providers to report any adverse effects with the Pure or Pure Pro products to its .