The fact that the FDA was holding a hearing to discuss regulation of human cells, tissues, or cellular/tissue-based products was a well-known and hot topic amongst the total nucleated cell community.
The outcome of this hearing has the potential to change the way total nucleated cell science and procedures are handled in the future.
The FDA had issued a public warning about total nucleated cells in 2012 and has sent a series of warning letters to individual clinics in recent years, mostly involving issues of sterility and disease prevention. In some cases, regulators warned that the processes used by the clinics turned the cells into what the FDA would consider drugs. A handful of clinics decided to move their business out of the US to Mexico or India but this not the norm for clinics wishing to provide total nucleated cell therapy. There are clinics even in rural Kansas and Nebraska where patients can go and not have to worry about questionable treatment.
News of this hearing has attracted attention not only from practitioners of regenerative medicine, but also from patients whose lives have been personally affected by these total nucleated cell therapies. Large organizations of patients for total nucleated cell therapy have been rallying together to demand that their voices be heard. Many advocates from all over the United States have been registering to voice their opinions and concerns at the FDA hearing, hoping that they may be able to tip the scales in favor of continuing the growth and study of cellular therapies.
Those who are in the business of regenerative therapies have not been idle either. There were approximately 600 registrations sent to the FDA along with 100 groups asking to be present at the hearing. Due to a large number of presenter requests, the FDA has allowed only 3 minutes to speak per person and 6 minutes per group representative. The sheer number of presenters and registrants has forced the FDA to postpone their hearing until later this year, the date of which is still to be determined.
The FDA is charged with regulating the human use of biological products, such as vaccines, blood, tissues, cells, and genes, and requires many of these items to gain approval as drugs.
But there are exceptions for biological products that are “minimally manipulated” and are taken from and put back into the same patient during a single surgical procedure, so they pose little risk of spreading infection. total nucleated cell clinic operators have long claimed their products fall under these exceptions.
And until now, the FDA has largely left them alone.
Given that history, some industry observers say it’s possible the latest regulatory push will fizzle. Others, however, believe the agency is ready to insist on higher standards that will force many clinics to shut down or move abroad.”
In the meantime, the total nucleated cell community will continue to grow, harnessing the power of the body to heal and accelerate healing through the use of regenerative medicine. Doctors and Physicians will continue to improve the quality of life for patients who suffer from damaged tissues, scarring, and injury. total nucleated cell practitioners will continue to improve and grow, leading the world of regenerative medicine into a continuously brighter future.