FDA Sends Stern Warning to Stem Cell Industry

Over the last several years the stem cell industry has broadened and shifted into areas of medicine that no one could have imagined a decade ago. In many instances, lives have been saved by cutting-edge technology and new innovations in the capabilities of stem cells to treat diseases that were historically deemed incurable. However, there is a drawback. Many of these practices have not been approved by the Food and Drug Administration and have led to irreversible damage in some patients.

This week, the FDA sent a formal letter of warning to Cord for Life, a Florida-based cord banking business. The letter contained allegations of safety lapses and legal violations in their operation. The business sold umbilical cord blood products to a company called Liveyon for several months last year. Cord for Life officials insist that they have operated without scrutiny for over two decades in the cord banking business and it was only after their relationship with Liveyon that problems occurred. Liveyon obtained umbilical cord blood-derived stem cell products from a San Diego manufacturer in 2018 which were injected into patients. At least fifteen of these patients were hospitalized shortly after with bacterial infections as a result of those injections. Liveyon promptly cut ties with the San Diego based manufacturer and began a relationship with Cord for Life to supply their blood products. Cord for Life asserts that it has taken steps to address the concerns of the FDA.

Twenty other companies providing stem cell services also received letters reminding them that they are violating federal laws by selling unapproved products. These companies and thousands of others have appeared over the last several years offering stem cell therapies that claim to treat Crohn’s disease, multiple sclerosis, and Alzheimer’s along with hundreds of other conditions. The techniques are not substantiated by science or authorized by the government.

These clinics have been allowed to multiply over the years due to the inaction of the FDA, even as consumer advocates and doctors have pressured the agency to take more aggressive action against them. Critics of the FDA see the letters as too little, too late. They are concerned that twenty letters will do little to change the practices of thousands of clinics operating out of the realm of control. Officials with the FDA say that warning letters have been sent out five times over the last two years including the one issued this week.

Researchers are certain that stem cell studies will lead to better treatment and cures for some of the most deadly and debilitating diseases of our time, but the verdict is still out on protocol that could mean the difference in life and death for patients. Many in the scientific community refer to these illegally operating clinics as salesmen of modern day snake oil.
There are many documented cases of patients experiencing adverse reactions to stem cell treatments that are not yet FDA approved. Seventeen people were hospitalized this year with severe bacterial infections that were acquired through injections of stem cell products derived from umbilical cord blood. Another group of five patients suffered vision loss after treatments.

FDA officials agree that more needs to be done but in order to move forward, the actions of these companies must be documented and inspections must be conducted. The agency needs proof that those operating outside the law have disregarded the letters before any action may be taken.