In interviews with The Post, Kosolcharoen, 47, defended his company and its treatments. The FDA requested a response from Genetech, within 15 working days of the letters issuance, that details how the deviations noted in the warning letter will be corrected. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. He was completely unaware that claiming that Liveyon had MSCs was not regulatory compliant. The first reports of infected patients reached the CDC in September. reduced to how many come end of FDA 36 month roll out this Nov 2020??? I grew up in Shawnee and graduated from Mill Valley in 2017. Ive included here one screenshot of the type of marketing on their website that has come to be associated with the firm at right. If these products have any effect on patients, Fortier said, "it's not through live cells or growth factors. Many leading researchers compare the products being sold now to snake oil, saying there is little oversight, little scientific rationale for the procedures and little proof they have any effect. Regional chiropractors were "making a killing" on the shots, he said. Stem cell therapies have enormous promise, but the science in each use is still in the developmental stage. If this is of interest to you, I would like to set up a time to come and discuss how our MSC products would be a good compliment to your regenerative medicine clinic . Really Paul? "Her kidneys were shutting down, and they were worried she was going to have a heart attack," Dilley said. Its also not exosomes but conditioned medium containing fetal bovine serum that is going to kill someone. All rights reserved. These 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. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications. DUH!!! Before sharing sensitive information, make sure you're on a federal government site. In addition, a major market for Liveyon (as discussed in the Podcast above) is chiropractors, who are even less likely to know which end is up with flow cytometry. More Recalls, Market //]]>. LIVING BEYOND is its name LIVEYON so can I please share to some great folk of doctor and patient alike to not fear from all the negative nay sayers on the internet meant to stir the pot to redirect the public to not trust LIVEYON when like OVERSTOCK owner and IPHONE founder who blazed their own high road within the industrys industry few follow but the voice of science and many future clinical trials will vindicate the integrity and real character of JOHN K. as he helps change the paradigm of medical history through LIVEYON products for you need thee absolute consistency of each & every vial to to get reproducible favorable results so my bet is on this company to change or extend my life anyday. Many clinics use patients' own tissue -belly fat, blood or bone marrow - to fashion treatments. Two months after filing Liveyon's incorporation documents, Kosolcharoen pleaded guilty to defrauding the military health-care system. In the weeks since then, CDC officials said, they have obtained many more ReGen vials directly from Liveyon and found bacteria in a large proportion of them. It is a member of the Be The Match Program and has passed all FDA inspections. He pleaded guilty on August 23, 2016 to one federal felony after it was alleged that he had headed a TRICARE kickback and fake prescriptions scheme from late 2014 through his arrest date. I talk about what I know and the science of it.". The same producer, James Buzzacco, did both commercials too. Asked to comment on the case, Gaveck said the phone call occurred before Liveyon had gotten the first reports of bacterial infections in patients. Run from this company. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. GODSPEED. Liveyon has voluntarily recalled all ReGen Series products due to reported possible adverse reactions. Pros. Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. Liveyon hired 10 new employees, Kosolcharoen said, and plans to hold 36 seminars in the coming year to teach chiropractors and pain doctors about its treatments. Liveyon has secured a manufacturer which has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility. After years of back pain, Timothy Lunceford decided in July to try an injection of umbilical cord blood, an unproven treatment increasingly touted by chiropractors and pain doctors as a cure for achy joints. "We're just the tip of the iceberg, and we're the cleanest in the iceberg," Kosolcharoen said. Three additional patients in Texas and Maine have filed lawsuits against Liveyon claiming the company's product infected them with bacteria. Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. You will see the number will be low. Despite receiving an FDA Warning Letter about the claims it made of selling stem cells for its contaminated Regen Series product, the company still claims to sell a stem cell product on its website today. In return, Kosolcharoen received more than US$600,000 from a compounding pharmacy that supplied the cream, the affidavit said. Kosolcharoen said he continues to believe that doctor error contributed to the rash of infections. The FDA is committed to advancing the field of cell-based regenerative medicine. Again, this is like saying that we have cars that are red, are not Coupes, are convertibles, are not Porsches, are Mercedes, are SL500s etc However, to find the red Mercedes SL500 convertible, it needs to have all of those properties and be missing others. Gaveck, meanwhile, no longer holds a medical license. Time is running out for firms to come into compliance during our period of enforcement discretion. It is the only company that has its FDA registered lab and since last winter of 2019 produces and mfg it own products A yo Z cause it learned the hard way that at the end of the day; rogue contractors or third party mfg trust cannot be trusted 24/7 as you gotta be the only cook in your own kitchen.. (lab). All Rights Reserved. This again is just like the car we want. For example: a. Liveyon Labs failed to adequately validate the aseptic process used to manufacture your PURE and PURE PRO products since operations began in January 2019. The same producer, James Buzzacco, did both commercials too. The medical board alleged at the time that she had engaged in many instances of prescribing HGH for improper purposes. LIVEYON was a victim of this hurrendous negative as much as those innocent patients that got the bacteria were. Meanwhile, the company is planning a rapid expansion. In this case, the companys failure to put in place appropriate safeguards may have led to serious blood infections in patients, said FDA Commissioner Scott Gottlieb, M.D. Among them is John Herzog, 63, an osteopathic physician in Falmouth, Maine, whose case was not among the 12 investigated by CDC. The media fill batch sizes used for your validation study LL-VAL-004, entitled Validation of Aseptic Processing of the PURE Product, did not represent the maximum commercial batch size. Within minutes of the injection, however, Herzog said, his knee ballooned, and he couldn't straighten his leg. Kosolcharoen said he knew nothing about the FDA's findings at Genetech until several months after the June inspection. Genentech went rogue and since LIVEYON was helping the docs with all aspects of biz the other folk started to spin 99% negatives. You have my opinion here but does not take a rocket scientist to see zero future doing the right thing LIVEYON. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Integrative Regenerative Medicine Consultant, Regenerative Medicine Consultant and Sales. If you recall all those gold rushers in the Wild Wild West of our CA gold rush . very few actually found gold but the person who sold the tools to implement & extend each gold rushers intended plan were the actual winners financially overall. They are already aggressively marketing vials being produced by their new lab under the label "Liveyon Pure" and have increased their asking price by US$200 a vial. The products are. "Patients should be aware of the unproven benefits and the . In order to market them in a compliant way you must have prior FDA approval. They report: Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric. On September 28, after the FDA and other health officials inquired about the infected patients, the company issued a recall for all treatment vials marketed under the name "Liveyon ReGen". Liveyon's Live 'Pure-Cast' Podcast Series Sheds Light on Miseducation In addition, they were the subject of the podcast Bad Batch that shone a bright light on the company. We dont see too many people defending this firm. Here are some of the FDA findings when they inspected LIVEYON: At the close of the inspection, FDA investigators issued a Form FDA 483 to Erin M. Sairafe, Chief Compliance Officer for both Liveyon Labs and Liveyon LLC, listing inspectional observations, which described a number of significant deviations from CGMP and CGTP. An FDA inspection of the Liveyon Labs and Liveyon LLC facility in May revealed the companies were processing and distributing products derived from human umbilical cord blood for use in patients who were unrelated to the donors. Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process. You are really reaching for straws to try and and slander Liveyon. A John W. Kosolcharoen, who at the time lived in Santa Ana, 12.3 miles from Yorba Linda, was arrested June 20, 2016 after a lengthy FBI investigation. Liveyon also recently opened its own clinic in Cancun, Mexico, Kosolcharoen said, so that American patients can receive its treatments unfettered by FDA regulations. "We're a victim as much as the patients who were infected," Liveyon's founder and chief executive, John Kosolcharoen, said in one of several interviews with The Post. month to month.}. FDA officials said the agency lacks the resources to pursue a comprehensive crackdown on the sprawling stem cell industry. FDA also sending letters to other firms and providers offering stem cell treatments. Who Is Liveyon and What Are They Really Selling? Does NurOwn from BrainStorm Cell Therapeutics still provide hope for ALS? Several other firms seem to be actively supplying materials to customers. All but two of the illnesses have been linked to a single company: Liveyon of Yorba Linda, California. FDA warns Liveyon for selling unapproved umbilical cord blood products I call it an unheard of A+++ endorsement as of last May 2019 . In the case of these flow markers, a mesenchymal stem cell would need to have CD73 and CD90 present, plus CD105 that wasnt tested here. Geez. This is obviously a smear campaign. ", Dorothy O'Connell was hospitalized with a dangerous infection. So the Liveyon email is like the used car salesman here, just repeating that they have loads of cells with CD73, some of which may or may not be the cell youre looking for. She said they also contained very few "growth factors" - substances that many companies often claim stimulate healing. In the hospital, doctors found two types of bacteria, and Herzog said he was later diagnosed with a bone infection and a related blood clot. "There's now a marketplace where arguably hundreds of millions of dollars are being made," said Mark Schwartz, a former top official for the FDA's Center for Biologics Evaluation and Research. False hope for autism in the stem-cell underground Liveyon is a cord blood product marketer that distributed a batch of cells a couple of years back that led to many patients being hospitalized with infections. Now her mother has been left with damaged vision, hearing and balance, Dilley said, and has had to learn how to walk again. We apologize for this inconvenience, & our engineers are working diligently to get this resolved ASAP. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Ya kinda of think Genetech either planted it or simply got sloppy with greed because they knew LIVEYON was building their own lab which would have been done late fall or early winter of this coincidental timing so their exclusive payday was obviously ending after a second year contract as originally contracting GENETECH MFG was only till LIVEYONs own lab was complete. Also, in the commercial video on the Liveyon Luma website they mention stem cell enhanced skin treatments, which potentially brings stem cell drug products into the mix too. but made them FAR BETTER EQUIPPED FOR REGENERATIVE FUTURE because they did the right thing when this all came to light. What about the FDA or other agencies proactively stopping such marketing of risky and unproven cell products?