The global stem cell therapy market is undergoing unbridled expansion, and is projected to reach 15.63 billion USD by 2025. Unsurprisingly, competition has intensified, giving rise to hordes of new centers throughout the United States.
Pursuit of market domination has pushed many physicians, nurse practitioners, chiropractors, and other health care professionals to evade critical regulations.
As discussed in our educational video (“What are Stem Cells”), there are numerous sources of stem cells, including cord blood. The Food and Drug Administration (FDA) has provided clear guidance on appropriate use, specifying that:
Cord blood is approved only for use in “hematopoietic stem cell transplantation” procedures, which are done in patients with disorders affecting the hematopoietic (blood forming) system. Currently, the only approved use of cord blood is for treatment of blood-related illnesses.
In direct defiance of these guidelines, many centers are selling off the shelf packages of unregulated umbilical cord blood, umbilical tissue, and amniotic cells at deeply discounted prices.
GIOSTAR Chicago believes that consumers should be thoroughly educated before making critical decisions about their health care. Our latest blog posts examines how this trend can impact you as a patient, with a focus on two key players in this market: Predictive Biotech and Liveyon.
Predictive Biotech: “Do it, but don’t tell us, heh heh heh”
Predictive Biotech sells two core products – Corecyte and Polycyte – containing live mesenchymal stem cells (MSC’s) from Wharton’s jelly allograft of the umbilical cord. The company claims that, for $1,500, a physician can receive a 1 ml vial of Corecyte that contains 800,000 live post thawed MSCs.
This is concerning for several reasons:
- The practice violates previous guidance from the FDA about acceptable use of cord products.
- The sales pitch is a blatant lie, as demonstrated by extensive research. Lisa Fortier – a well-respected authority in regenerative medicine from Cornell University – for instance, found zero live stem cells and few growth factors in a randomly selected collection of nine cord blood products. Additionally, Mariane Secco and a research team from University of São Paulo found that that only 10-20% of an extensive sample of umbilical cords contained MSC’s. In other words, in 90% of the cord blood surveyed, researchers derived NO MSCs.
- Predictive Biotech estimates that more than 400 stem cell centers are using their products in the United States. In blindly buying their pitch, and failing to perform any due diligence before administering the Corecyte product, they have no idea what they are actually injecting into their patients.
- GIOSTAR Chicago consistently succeeds in extracting 5 to 15 million autologous cells from our patients (this depends on many factors, including the patient’s overall biology).
This success rate is attributed largely to the innovative scientific protocols developed by our Co-Founder and Chief Scientific Officer Dr. Anand Srivastava.
Predictive Biotech’s false claims – that their Corecyte and Polycyte products contain 500,000 to 2 million MSCs per vial – greatly tarnish the pioneering regenerative medicine research by GIOSTAR.
Equally shocking is Predictive’s outright shirking of responsibility in the stem cell administration process; listen to a “pitch” that a company representative provided to a GIOSTAR Chicago representative during a phone conversation:
“Yes, we sell these cellular products to doctors. However, we are not responsible for the administration of these cells to patients by these doctors. The administration of these cell products is ‘very hush hush’ and we tell our doctors, ‘do it, but don’t tell us, heh heh heh.’ We don’t want to know what these doctors are doing with the product. All we do is supply the cells.”
Liveyon: Serious Infections and Failed Inspections
Liveyon is another provider of cellular products derived from the umbilical cord, whose recent timeline should give patients pause:
- June 2018: as reports begin to circulate about patients receiving infections from Liveyon products, an FDA inspection of the facilities of Genetech (the manufacturer of their umbilical cord product) reveals infractions of numerous sterility and safety manufacturing requirements.
- Key among these is consistency in screening donor cells for communicable diseases. Investigators find bacteria in 8 of 10 unopened vials of Liveyon treatments from Texas and Florida centers where patients have reported infections. Liveyon continues distributing vials of “Liveyon ReGen” through the summer and into the fall.
- September 2018: The CDC begins receiving reports of Liveyon patients receiving infections. An inquiry by the FDA and other health officials about the infected patients prompts a company recall of treatment vials marketed under the name “Liveyon ReGen.” Liveyon then rebrands the product “Liveyon Premier MAXCB,” which it begins sourcing from a different supplier.
- October 2018: Patients continue reporting infections after receiving the Liveyon products.
- November 2018: The FDA agency issues a formal warning to Genetech, notifying them that they are selling an unapproved product.
- December 2018: The United States Centers for Disease Control and Prevention (CDC) issues reports linking Liveyon products with infections of the bloodstream (Enterobacter cloacae and Citrobacter freundii) and spinal discs, infected bones, and joints (Escherichia coli, Enterococcus faecalis, and Proteus mirabilis) in more than 10 patients. The CDC found that the bacterial contamination probably “occurred before distribution” to doctors.
This turn of events is unsurprising given the checkered backgrounds of the company’s co-founders:
- Prior to founding Liveyon in 2016, John Kosolcharoen had been involved in defrauding the military health care system, bilking more than 80 investors through a multi-million dollar Ponzi scheme, and numerous other unsavory exploits.
- Liveyon co-founder and “medical expert” is Alan Gaveck, a (now former) podiatrist who lost his medical license and was censured by the Arizona State Board of Podiatry in 2007 for a botched toe surgery.
Despite Liveyon’s attempts to resuscitate its severely tarnished name, the fallout continues. As recently as August 2019, reports continue to emerge of patients experiencing complications in Kansas City, Miami, and many other locations after undergoing Liveyon treatments.
The Broader Impact
Liveyon and Predictive Biotech are only the tip of the iceberg; the stem cell therapy market is crawling with characters who make a mockery out of the practice of medicine and are selling these vials at a mark-up for their own monetary benefit, abusing the trust of their patients. Many centers have begun to peddle discarded placentas, amniotic tissue, umbilical tissue, cord blood and other products that run afoul of FDA policies and procedures. Any product that can be created and injected that easily by a physician without any lab processes or extensive scientific in-house protocols, is too good to be true
Unfortunately, patients fail to realize that administration of these cellular products is not “kosher,” and often don’t know where these products are sourced or manufactured.
This raises several concerns: Why isn’t anyone worried about the fact that these “swindler” physicians are getting away with administering these cells and thereby putting the patient at risk? Isn’t anyone concerned about what these charlatans are actually injecting into these poor patients?
Beware of the cord blood, umbilical tissue, and amniotic products being sold to patients for dirt cheap. You get what you pay for and apparently, it could include a serious bacterial infection.