During this time period, donors tested positive for ZIKV, Hepatitis B, and syphilis. In a test of 9 products - none of them from Liveyon - Fortier found that none contained stem cells, or a single live cell of any kind. The CDC team also used next-gen sequencing to determine that all of the contamination likely originated from one source. The FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli), as described in a Morbidity and Mortality Weekly Report (MMWR), titled Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions United States, 2018.. Kosolcharoen said he benefited from stem cell therapies in 2012, after falling off a balcony and shattering his knee. Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. The for-profit stem cell business is nonetheless booming. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. CBER stated concerns related to the products manufactured by Genetech and informed Liveyon of reported possible adverse reactions due to the use of the ReGen Series product. But, there is still no ETA for everything to work normally again. iv. After two days, he was feverish and could hardly move. O'Connell was airlifted 50 miles (80 kilometres) north to a hospital in Houston. "I had a very busy surgical practice and, yes, I had a malpractice suit," Gaveck said in a telephone interview. Glad to read this smearing review. b. Liveyon Labs failed to thoroughly investigate five in-process BSC settling plates failures. Who Is Liveyon and What Are They Really Selling? "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. Genentech went rogue and since LIVEYON was helping the docs with all aspects of biz the other folk started to spin 99% negatives. Whatever testing on other products may show, tests paid for by Liveyon have indicated that its vials contain live cells and stem cells, according to a self-published company report. just faithfully (after this better reformulation and transformation) better extend patients lives doing what they wanna do . Try. As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the Federal Food, Drug, and Cosmetic Act and FDAs regulations during the period in which the agency intends to exercise enforcement discretion for certain products with respect to FDAs investigational new drug and premarket approval requirements, when the use of the product does not raise reported safety concerns or potential significant safety concerns. Academic experts have identified at least 716 US stem cell clinics and say the true number probably exceeds 1,000. Before sharing sensitive information, make sure you're on a federal government site. LIVEYON from day one in industry was already building their own lab (kitchen) because they did not like having third party mfg constraints yet never thought GENETECH would ever secretly cut agreed contractual corners. To me thats John K / LIVEYON . What about the FDA or other agencies proactively stopping such marketing of risky and unproven cell products? 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. Their leader John Kosolcharoen? The site is secure. month to month. You will see the number will be low. Two months after filing Liveyon's incorporation documents, Kosolcharoen pleaded guilty to defrauding the military health-care system. They started selling another in-house produced product. Until recently, Liveyon also did not engage directly in manufacturing. Liveyon will resume distribution of the new product line effective Monday, October 8, 2018. What about in our country? After cropping up overseas in countries such as Thailand and China, the industry has flourished in the United States - without much resistance, until recently, from the FDA or other federal regulators. The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. Health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products or other stem cell treatments to the FDAs MedWatch Adverse Event Reporting program. Were implementing new policies to make it more efficient to safely develop these promising new technologies. The medical board alleged at the time that she had engaged in many instances of prescribing HGH for improper purposes. 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. "You guys" as in "Are you guys ready to order?". The paper is entitledInvestigation of Bacterial Infections Among Patients Treated With Umbilical Cord BloodDerived Products Marketed as Stem Cell Therapies by Hartnett, et al. So far, Liveyon has not received a warning letter from the FDA, even though federal regulations say distributors are responsible for their products' safety. Whats your interest? Nurses gave him antibiotics to fight life-threatening sepsis, and a neurosurgeon scraped infected tissue from his spine. Three of the 12 patients were hospitalized for a month or more, the report said. The agency continues to urge these manufacturers to engage with the agency about their regulatory requirements in the coming months.. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? 50th President of the CSRS, Tyber Medical Acquires French Orthopedic Medical Device Company, Texas Docs Sue Over No-Surprises-Act 600% Fee Increase. Contact Who is Liveyon Headquarters 7700 Irvine Center Dr Ste 800, Irvine, California, 92618, United States Phone Number (949) 753-2870 Website www.liveyon.com Revenue $16.5M Industry Business Services General Business Services Liveyon's Social Media Is this data correct? In order to market them in a compliant way you must have prior FDA approval. Eventually, researchers say, stem cells could be used to treat many diseases, including macular degeneration, diabetes and Parkinson's. Over the past two years, Kosolcharoen said the company has sold 25,000 vials at US$1,500 for a single-injection dose or US$1,800 for a multiple-injection dose. As such, the products are regulated as both drug and biological products. The most recent email I sent to Kosolcharoen some months back did not receive a reply. Save my name, email, and website in this browser for the next time I comment. Liveyon LLC was incorporated on June 13, 2016. He was completely unaware that claiming that Liveyon had MSCs was not regulatory compliant. Imagine if dozens of more patients had been injected with those 34 vials. The same producer, James Buzzacco, did both commercials too. The number was actually much higher it seems, based on a new report. However, the FDA does not intend to exercise such enforcement discretion for those products that pose a reported safety concern or a potential significant safety concern to patients. "But there's nothing inherently magical about placental tissue or the amniotic sac.". Kosolcharoen said the recent infections will not impede Liveyon's success. Many clinics use patients' own tissue -belly fat, blood or bone marrow - to fashion treatments. Why? Kosolcharoen and Gaveck said it would have taken too long to set up their own manufacturing operation, so they turned to Exeligen Scientific in San Diego. To learn more about flow cytometry, see my video below: Below is an actual CFU-f test conducted by the CSU Translational Medicine Institute on multiple umbilical cord products, including Liveyon Pure: The purple dots to the right represent the stem cell content of middle-aged and elderly bone marrow. In return, Kosolcharoen received more than US$600,000 from a compounding pharmacy that supplied the cream, the affidavit said. Similar tests at our lab also got the same result: The upshot? The agency issued a formal warning to the company in November and told Genetech it was selling an unapproved product. Many successful companies have alot to overcome at certain points but its those very AMERICAN failure issues . Stem cells can divide and renew themselves over long periods, and some can grow into any kind of cell in the body. Required fields are marked *. Close, but no cigar. In the case of Genetech, the FDA inspected the companys facility this past June and found the company was processing cellular products from human umbilical cord blood for administration by intra-articular (joint) injection, intravenous injection or application directly to the affected tissue to treat a variety of orthopedic conditions. 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. Liveyon also voluntarily recalled all Genetech products it may have distributed. "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. The FDA offers opportunities for this type of engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. iii. She said they also contained very few "growth factors" - substances that many companies often claim stimulate healing. FGF for Liveyon was about 5; our 1X PRP was 61.4. It has to be a convertible and not a Coupe. ate current information from clinical trials. Those sales have brought in tens of millions of dollars in revenue, Kosolcharoen said, but he said the company's profits so far have been modest because of start-up and overhead costs. Weekly reads: He Jiankui disappoints, ALS, Vor Biopharma, Top 50 stem cell influencers to follow on Twitter, List of FDA Approved Stem Cell Therapies & Drugs, Fact-checking stem cell supplements in 2023, What is PRP injection cost, risks, & possible benefits. 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. "I probably did have a conversation with him," Gaveck said. Its also not exosomes but conditioned medium containing fetal bovine serum that is going to kill someone. Working closely with the FDA, Liveyon has executed a strategic recall action plan and has immediately begun the voluntary recall process. As highlighted in 2017 with the release of the FDAs comprehensive regenerative medicine policy framework, including the FDAs final guidance (Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use), the FDA is applying a risk-based approach to compliance and enforcement of cell-based regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended to be used. These products were distributed by Liveyon in Yorba Linda, California as ReGen5, ReGen10 and ReGen30. The FDA's warning letter, dated Dec. 5, went to Liveyon Labs, which processes umbilical cord blood to make products called Pure and Pure Pro, and its distributor, Liveyon LLC. GODSPEED. Time is running out for firms to come into compliance during our period of enforcement discretion. Within minutes of the injection, however, Herzog said, his knee ballooned, and he couldn't straighten his leg. This (b)(4) and (b)(4) are labeled For research use only.. The site is secure. 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. That lead to a contaminated product which placed many people in the ICU. c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. In an interview, Kosolcharoen said he didn't deliberately defraud anyone. Heart stem cells trial mostly disappoints but is oversold, Stem cell research ethics topics: organoid consciousness & embryo models, Weekly reads: bat stem cells & viruses, Lineage Cell, He Jiankui visa. To file a report, use the MedWatch Online Voluntary Reporting Form. "People have been putting things like that in creams and shampoo for ages," she said. All but two of the illnesses have been linked to a single company: Liveyon of Yorba Linda, California. You identified the contaminating organism(s) for your sterility failures but destroyed these batches without initiating/conducting an investigation using FORM-LL-037, entitled Positive Sterility or EM Failure-Root Cause Analysis. In addition to the warning letter released today, the FDA has issued a safety alert about exosome products. Geez. b. Liveyon Labs processed cord blood units from two different donors (b)(4). Liveyon officials said executives at Exeligen set up a third company in San Diego, called Genetech, to produce Liveyon's vials. Withdrawals, & In an administrative hearing on the case, the SEC said Kosolcharoen worked for a Dallas-based medical insurance company, Global Corporate Alliance, which SEC officials described as "a US$10 million Ponzi scheme that victimized at least 80 investors.". Kosolcharoen said he started Liveyon in 2016, after years of working as an entrepreneur in the insurance, real estate and telemedicine industries. At the time, inspectors reprimanded Genetech for not following safe manufacturing practices - such as consistently screening donor cells for communicable diseases, FDA records show. "The future for Liveyon," Kosolcharoen said, "is the brightest it's ever been.". Founded in 2016, Liveyon and Liveyon Labs Inc. are committed to achieving unparalleled stem cell potency through high live nucleated cell counts, while following validation protocols that produce . ", Dorothy O'Connell was hospitalized with a dangerous infection. The new manufacturer is a US-based, FDA. However all the negatives and many shortcoming with each and every one from this fiasco was OVERCOME by LIVEYON. It is difficult to impose a "regulatory architecture after an industry has sort of grown up," Gottlieb said. They are in it for a quick buck. Blaming the California company that manufactured the vials, Liveyon executives said they hired a new manufacturer in Florida and changed the name of their product to "Liveyon Premier MAXCB". Home Blog Liveyon Keeps Misleading Physicians. We are currently experiencing a system-wide issue with a delay on all activations. 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. DUH!!! They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. "Her kidneys were shutting down, and they were worried she was going to have a heart attack," Dilley said. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Genetech, Inc. warned about umbilical cord blood-derived cellular products distributed by Liveyon, LLC. In June - about the time Liveyon first started hearing from providers about infected patients - an FDA inspection of Genetech's facility found numerous sterility and safety lapses, according to FDA records. However, the CDC found that the bacterial contamination probably "occurred before distribution" to doctors. In an interview, Kosolcharoen said that he was duped by the company and that he and his relatives lost money when authorities exposed the scheme. The DT-001 Form 4 Donor Risk Assessment Interview received from cord blood supplier (b)(4) did not indicate if the donor has been diagnosed with Creutzfeldt-Jacob disease (CJD) or variant Creutzfeldt-Jacob disease (vCJD). You folks should have better things to do. Liveyon immediately discontinued the purchase any product from Genetech and has procured new product from an alternative manufacturer. As to the specific pathogens they write, The most frequently isolated bacteria from patients with infections were common enteric species, includingEscherichia coli(14 patients) andEnterobacter cloacae(7 patients). More accurate and reminds the guest they are in a hospitality environment. All Rights Reserved. This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. Meaning the flow data doesnt show anything of the sort. Instead of. Similar tests at our lab also got the same result. These reports were brought to the FDAs attention by the Centers for Disease Control and Prevention, among others, and the agencies worked with the Nebraska Department of Health and Human Services. In addition, the FDA recently announced a temporary program called the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), which is intended to assist manufacturers of human cells, tissues and cellular and tissue-based products (including stem cells) to obtain a rapid, preliminary, informal, non-binding assessment from the agency regarding how their specific products are regulated. You know from above that CD73 is just one of many markers, like saying that the dealer has lots of red cars. Another LinkedIn search by the Liveyon company name found many apparent employees so maybe they are still active in the umbilical cord space?