The New York Times did a hatchet job on regenerative medicine. A visiting researcher at New York-Presbyterian/Weill Cornell Medical Center and other surgeons had performed numerous surgeries using BioBurst, a processed umbilical cord fluid, to help fuse together bones in minimally invasive surgeries. The fluid was administered to reduce healing time and reduce the need for more invasive back surgery. The New York Times had this to say:
…about 40 patients at the hospital had received treatment with the fluid under the direction of Dr. Roger Härtl, a senior surgeon and professor at Weill Cornell, who is also a physician for the New York Giants. The surgeries were documented in a draft study that Dr. Härtl and others, including the visiting researcher, had intended to publish, tracking the fluid’s effectiveness in fusing delicate bones.
Dozens of other medical centers, including prestigious institutions like Duke University Health System and the George Washington University Hospital, also listed the fluid, known as BioBurst, on their hospital pricing records…
Sounds good right? Not according to the New York Times, and the U.S. Food and Drug Administration (FDA). The problem: The FDA had decided several years earlier that it now considers minimally-processed tissue products to be biological drugs that require FDA approval, rather than simple tissue products derived from donated tissues. The surgeons did not realize BioBurst Fluid, a product they used for several years, was now considered an unapproved drug. Dr. Härtl used the fluid many times between 2019 and 2021 as an alternative to bond grafting in minimally invasive spinal surgeries. He told the New York Times that he
“did not receive any patient complaints or see any unexpected adverse events, such as infections or revision surgeries, directly associated with the use of BioBurst Fluid.”
“My goal has always been to reduce the pain and suffering of patients by advancing the effectiveness of spine surgery.”
By the way, it is also against FDA regulations to remove stem cells from your own body, propagate them and reinsert in your own body. The FDA considers that an unapproved biological drug. A doctor can legally retrieve your own stem cells and reinsert them back into your body. That fits the FDA’s definition of minimally processed. However, if a lab does anything to increase the number of your own stem cells (i.e., propagate them) to help, say, knee cartilage regenerate, then that becomes an unapproved drug.
The manufacturer of the fluid profiled in the New York Times article, Burst Biologics, is now out of business. The founder had to declare bankruptcy, while his former employees are looking for other jobs and his lab equipment auctioned off. This is unfortunate because the surgeons mentioned in the hatchet piece were preparing to publish clinical observations on the product showing “promising results.”
The following link is to a National Library of Medicine abstract, published in the Journal Regenerative Medicine, explaining the potential of cytokines in umbilical cord blood-derived cellular products to repair bone. More from the New York Times:
The fluid belongs to a growing area of medicine that has drawn stepped-up attention from regulators. There are about 3,000 active investigational drug applications for cell and gene therapies, according to the F.D.A. Patients have clamored for the therapies to treat Parkinson’s disease, autism, arthritis, back pain and other conditions…
Of the 3,000 products currently under investigation, the FDA has approved only about 30 cellular and gene therapy products. In other words, it could take decades before the FDA approves a substantial number of regenerative medicine therapies. Also be prepared to sign over your house because the restrictive nature of the FDA’s approval process guarantees they will face little competition.
Many cellular and tissue products have been in use for years prior to the FDA crackdown. Oddly enough, the 21st Century Cures Act, singled by President Obama in 2016, gave the FDA considerable leeway to approve new therapies. This new power includes a new expedited option for biologics products for Regenerative Medicine Advanced Therapy. That new power was intended to prod the stogy agency to create an expedited path for new regenerative therapies. Instead, the FDA actively began shutting down products and experiments when their developers could not afford the hundreds of millions required to meet the FDA’s high bar for investigational new drug applications and approval.
Wharton’s Jelly is another product made from donated umbilical cords and processed into a product used in regenerative medicine. I wrote earlier about the FDA’s vendetta against Wharton’s Jelly here and here, saying:
The most recent company affected is Florida-based Regenative Labs, but there are numerous others. These firms sell regenerative products to physicians, clinics, research labs, hospitals, and customers abroad. They will have to stop unless their products are used for research only.
Tissue therapies, such as Wharton’s Jelly, are used to regenerate damaged tissues and heal injuries. English physician and anatomist Thomas Wharton first described it in 1656, so it’s not exactly new.
The point of the FDA’s recent initiative is presumably to put a stop to all use of regenerative medicine therapies outside of tightly controlled clinical studies. Wouldn’t it have made more sense for the FDA to contact all the companies (the agency is trying to put out of business) and instead allow them to continue while monitoring patients for observational studies? The 21st Century Cures Act gives the FDA the power to use real world data and observational studies for new drug approval. Instead, the agency is reverting to its old playbook, which is basically “we don’t want to hear from you unless you’re willing to spend 10 years and invest $1 billion dollars on clinical trials.”