d. Liveyon Labs used a non-sterile (b)(4) and the associated non-sterile (b)(4) to manufacture approximately (b)(4) batches of your products between January 16, 2019 and May 20, 2019, raising the potential for microbiological contamination. But for some patients, lack of oversight of the multibillion-dollar industry has had disastrous consequences. After successfully injecting himself with stem cells and later his mother, he was convinced that he had found the answer that people were looking for, along with a way to make a lot of money. John Kosolcharoen 's Email Chief Executive Officer at Liveyon LLC Contact Details Phone +1******44 Get Phone Number Email jo*******@liveyon.com Get Email Address Department Finance & Administration Location Irvine, California, United States Liveyon LLC Company Information Website http://www.liveyon.com Head Count 100 - 250 CASE DISPOSED WITH DISPOSITION OF COURT FINDING, CASE DISMISSED WITH DISPOSITION OF COURT-ORDERED DISMISSAL. Academic experts have identified at least 716 U.S. stem cell clinics and say the true number probably exceeds 1,000. I asked him if anybody else has gotten sick off the stem cells. When Herzog expressed concerns about the products safety, a Liveyon sales person arranged a phone call with Gaveck, the companys top medical expert. ADDITIONAL LINKS Post Question For This Company Contact Us Regarding Your Company Profile Search All California Companies This caught Dilleys attention. The patient sued Gaveck for malpractice, he said; he later decided not to renew his medical license. 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. (b)(4) used in the manufacture of your products. Mark Holzer, 49, of Huntington Beach, charged earlier this month with making a fraudulent claim that he was disabled and unable to perform his job at the U.S. He began with an interest in medical tourism; some Americans were spending tens of thousands of dollars each on international travel for stem cell treatments. AMENDED COMPLAINT DISPOSED WITH DISPOSITION OF COURT-ORDERED DISMISSAL. Now her mother has been left with damaged vision, hearing and balance, Dilley said, and has had to learn how to walk again. A nurse practitioner from a clinic that Pierce was partnering with at the time told the audience about a stroke patient whose symptoms had improved after she gave him stem cells mixed with mannitol, a substance to help them cross into his brain. is liveyon still in business. More recently, practitioners have begun offering treatments manufactured from birth-related products, including discarded placentas, amniotic tissue, umbilical cords and cord blood. Mother of Liveyon CEO Shares Heartfelt Stem Cell Success - BioSpace United States. The for-profit stem cell business is nonetheless booming. He told me its not even clear that some of the offerings being touted as stem cell products contain any stem cells. The race is on to track down what went wrong with several patients in Texas before more people get hurt. Additionally, 1+ was inaccurately recorded as 1 CFU in the Positive Sterility and EM Log. The agency issued a formal warning to the company in November and told Genetech it was selling an unapproved product. Liveyons tax returns reveal that the company brought in more than $6million in sales in 2017, its first full year of operation. According to state medical board records, Albert has been disciplined twice, most recently in 2005 for gross negligence after charging a workers comp patient for services already covered by her insurer. Yet even as scientists touted the medical potential of stem cells, antiabortion groups opposed the use of embryos, and in 2001 President George W. Bush banned federal funding for the creation of new cell linesthose not already in laboratories for research. Theres a long lineup of people out there that are just waiting to defraud desperate patients by selling fake therapies that dont have the potential to benefit people, Morrison says. 26S075SIr 2017-09-01, Los Angeles County Superior Courts | Property | John W Kosolcharoen - Orange County, California, United States FDA sends warning to companies for offering unapproved umbilical cord E-FILING TRANSACTION 1650648 RECEIVED ON 08/01/2019 11:01:55 AM. (He says he was kept in the dark by the schemes ringleaders in Texas and thought the business was a legitimate investment opportunity for clients: I had my whole family invested, he says. MINUTES FINALIZED FOR CASE MANAGEMENT CONFERENCE 11/19/2012 09:00:00 AM. endobj CASE MANAGEMENT CONFERENCE SCHEDULED FOR 10/22/2019 AT 08:30:00 AM IN CX103 AT CIVIL COMPLEX CENTER. Everyone in the room listened to her story. John K. is a quintessentially American figure, a smooth talker who got in over his head Liveyon and he comes across as a very sympathetic character which makes him hard to hate. This is a BETA experience. Doctors there told Dilley that her mother was on the verge of a heart attack and that her kidneys were shutting down; they recommended she be airlifted to Houston. The people who make those arguments are the people trying to rip people off, Morrison explains. . But theres nothing inherently magical about placental tissue or the amniotic sac.. Even when biology suggests a plausible mechanism, you dont know until you do the studies. They may contain other kinds of cells, but not cells that have been shown to repair tissue, or they may not contain live cells at all. Simon Hong, 54, of Brea and his wife, Grace Hong, 50, who were arrested Monday and pleaded not guilty after being charged with billing Medicare for occupational therapy that was never provided at a facility they owned, JH Physical Therapy in Walnut. Everyone else in the waiting room, she recalls, started to discuss all the wonderful things they had heard about stem cells. They are part of C-Suite Department and Read More Contact John Kosolcharoen's Phone Number and Email Last Update 11/19/2022 6:07 PM Email j***@liveyon.com Engage via Email Contact Number (***) ***-**** Engage via Phone Mobile Number But in the absence of conclusive studies, its hard to know whether the improvement comes from something in the cells themselves or from the considerable power of the placebo effect. In August, Dilley accompanied her mother to a cardiologist appointment. Whats Up With All the Kangaroos on the Loose in Texas? Cancellation and Refund Policy, Privacy Policy, and In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). And You Thought Feral Hogs Were Bad. Earlier this year, it achieved a major victory when a judge ordered a Florida clinic to stop using fat-derived stem cells. AS SUCCESSOR BY MERGER TO WELLS FARGO HOME MORTGAGE, INC.; HSBC BANK USA, NATIONAL ASSOCIATION, AS TRUSTEE FOR WELLS FARGO HOME EWUITY TRUST 2004-2 ON 12/26/2012, COMPLAINT FILED BY KOSOLCHAROEN, JOHN W; KOSOLCHAROEN, ROYA ON 07/02/2012. According to an FBI affidavit, Kosolcharoen ran a sales team that persuaded soldiers to request prescriptions for a topical cream sold for pain, scarring, stretch marks, erectile dysfunction, or for general wellness. In return, Kosolcharoen received more than $600,000 from a compounding pharmacy that supplied the cream, the affidavit said. Surface monitoring is not conducted in the BSC for each fill. People who are desperate and have an incurable disease, they have a capacity to suspend disbelief, says Sean Morrison, a stem cell researcher at the University of Texas Southwestern Medical Center, in Dallas, and the former president of the International Society for Stem Cell Research. In recent years, though, her mothers pain had come to preoccupy her. Patients in several other states also became ill from contaminated stem cell products. Within days, she started throwing up, and I had to call an ambulance, Dilley said, adding that her mothers pain was so intense, you couldnt touch her., OConnell was airlifted 50 miles north to a hospital in Houston. OConnell received Liveyon injections for her arthritic back and neck on Sept. 12, according to her daughter, Elaine Dilley. 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I did more research into what I was just told and didnt find the answers that I liked, he says. Since operations began in January 2019, Liveyon Labs has processed cord blood units from(b)(4) donors supplied by (b)(4), located in (b)(4), and cord blood units from (b)(4) donors supplied by (b)(4), located in (b)(4). 8 Liveyon reviews. If you have any questions, please contact Mr. Cline at (949) 608-4433 or via e-mail. MINUTES FINALIZED FOR CASE MANAGEMENT CONFERENCE 02/04/2013 09:00:00 AM. U.S. FDA: Sends warning to companies for offering unapproved umbilical Who Is Liveyon and What Are They Really Selling? Join hosts, Liveyon CEO John W. Kosolcharoen and Director of Education Dr. Alan . Neither did the other patients Dilley met in the waiting room that day, among them Galen Dinning, a Dow Chemical retiree from Lake Jackson, and Deborah Williamson, also retired, a former teacher who was spending her life savings on the treatments. Seven from O.C. arrested in nationwide health fraud sweep 8. I keep questioning Liveyon. Many scientists say the injections like most stem cell therapies violate Food and Drug Administration rules against marketing unapproved drugs and are potentially dangerous. Liveyon Pure clinical trial grade, live nucleated stem cell product, that's more efficient, cleaner and optimally pure biologically. He gave little thought to his brief association with Genetech until a couple of years later, in October of 2018, when he was reading a popular stem cell blog and saw that patients had fallen ill after receiving stem cell treatments and that Liveyon had recalled its product. It was almost dinnertime when Dilley and her mother began the hour-plus drive back to Brazoria County. Theres no doubt in my mind that around the nation, stem cell manufacturers were watching House Bill 810 very, very closely and were so excited when it passed, says David Bales, the founder of Texans for Cures. A day after he got the shots, Luncefords back began throbbing. Dan Solomon writes about politics, music, food, sports, criminal justice, health care, film, and business. 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. Bad Batch Podcast Review: A Story of Stem Cells Gone Wrong In real stem cell therapies, we do pay close attention clinically to numbers of stem cells, he says. JOHN W. KOSOLCHAROEN Manager 7700 Irvine Center Dr Ste 800 Irvine, CA 92618 Reviews Write Review There are no reviews yet for this company. Compounding pharmacies formulate personalized medicines, but prosecutors said those involved prepared formulas aimed at the highest possible profit, not maximum effectiveness. It stated, [I]nitial investigation suggests that contamination occurred before distribution, meaning before the product was shipped to doctors offices. Information and records gathered at the time of and after the inspection, including product labeling and information on the Liveyon LLC website, https://liveyon.com, reflect that your products are intended to treat a variety of orthopedic conditions. They all were under the impression that the treatment would at the very least be safe, because it was being provided by a medical professional. John K. is a quintessentially American figure, a smooth talker who got in over his head Liveyon and he comes across as a very sympathetic character which makes him hard to hate. And then I think it was just basically being overwhelmed and being overrun. (In a written statement, the FDA said, We remain concerned that countless clinics across the country continue to market violative stem cell products to patients, claiming they dont fall under the regulatory provisions for drugs or biologics. I thought they would have gotten caught sooner, he tells me. What do you say to the argument that we know it works? I asked. One of my clients was hospitalized for fifty-plus days, and he tells these stories of hallucinations that were so vivid and so serious that he developed post-traumatic stress disorder.. 2020-04-14, San Diego County Superior Courts | Personal Injury | A Federal Judge in Amarillo Could Effectively Ban the Abortion Pill. E-FILING TRANSACTION 4997367 RECEIVED ON 08/02/2019 08:24:18 AM. Instead, patients received massage and acupuncture, which are not covered by Medicare. I can do a few things. She couldnt even get near the bed because of all the medical personnel in the room. Its daily. 262(a)(3); and 21 CFR Part 312]. Patrick Fortner, the executive director of the Texas Board of Chiropractic Examiners, told me that while investigations are ongoing, so far the board has not found instances of chiropractors either administering stem cells or ordering others to administer them. They get criticized on both sides. ADDITIONAL LINKS Post Question For This Company Contact Us Regarding Your Company Profile Search All California Companies The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. To launch the company, he brought on Alan Gaveck, 59, a podiatrist who serves as Liveyons top medical expert. Manufacturers, clinics and distributors like Liveyon have a vested interest in keeping this going and are not so easily scared off.. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. Four days after his arrest, Kosolcharoen signed an agreement with a San Diego biotech startup called Genetech (not to be confused with biotech giant Genentech), founded by a young scientist named David Aguilar, to make a stem cell product from donated umbilical cord blood. Liveyon LLC - Company Profile - Corporation Wiki Shes strong in her own right: in her twenties, she was one of the first women to operate a crane at the Dow Chemical plant in Lake Jackson. Medicare paid the clinic more than $3.7 million. TRICARE paid hundreds of millions of dollars for creams for minor pain, scars, erectile dysfunction or general wellness, prosecutors said. He assured the attendees that disease investigators had determined that the contamination in September 2018 was the fault of doctors, one of whom, he said, had E. coli all over his office. She stayed in pain from the time she got up until she went to bed, Dilley says. So when they go to these places to get these unproven therapies, they want to believe that they are going to benefit from it. As noted above and in the FDA Warning Letter issued on November 29, 2018, to your former contract manufacturer Genetech, Inc. with a copy to Liveyon LLC and Mr. Kosolcharoen, to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. Patients often didnt want the medicine or never had met the prescribing doctor. All other uses remain unproven. Failure to screen a donor of cells or tissues by reviewing the donors relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. Among its first customers was Rick Perry, then the governor of Texas, who received stem cell injections in conjunction with spine surgery. FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. These containers are labeled For research use only. The stem cells had worked, almost miraculously, it seemed to Crawford, so she wrote a column about them. Everything was glowing, glowing, Herzog said. Dilley has spent her whole life on the Gulf Coast, always in her mothers orbit. I just could not keep my mouth shut, she says. The most recent email I sent to Kosolcharoen some months back did not receive a reply. We report on vital issues from politics to education and are the indispensable authority on the Texas scene, covering everything from music to cultural events with insightful recommendations. That customer was Liveyon. The first person interviewed in the podcast is a man who tells us the story of his mother, who suffered a severe burn on her hand. Dinning was plagued by severe neck pain. 12 0 obj The Brazoria County patients who received the contaminated stem cells live in the shadow of what happened to them. x+r Studies have found that the more expensive a treatment, the stronger the placebo effectand patients are paying thousands of dollars for stem cell treatments. 7. Hardy quit. The first reports of infected patients reached the CDC in September. Laura Beil, host and reporter of Dr. Death, did an amazing job on a series that at times felt like a horror movie, but she just may have topped herself with her new six-part series, Bad Batch, that doesnt just call into question medical practices, but an entire largely unregulated industry - stem cells. The deviations in manufacturing processes observed as well as those noted in documents collected during the inspection indicate that the use of your products raises potential significant safety concerns. EX PARTE SCHEDULED FOR 08/02/2019 AT 08:30:00 AM IN C33 AT CENTRAL JUSTICE CENTER. endstream Her kidneys were shutting down, and they were worried she was going to have a heart attack, Dilley said. 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. Nurses gave him antibiotics to fight life-threatening sepsis, and a neurosurgeon scraped infected tissue from his spine. Before that, Kosolcharoen ran into trouble with the Securities and Exchange Commission. His wife, Anita Perry, currently serves on the board. Even more concerning was a tab that listed a host of conditions that stem cells could supposedly treat, including multiple sclerosis, Lyme disease, and Parkinsons. 262(a)]. The root cause and source of the contaminating organisms was not identified. But in the course of the research on that therapy, all the initial patients died of complications from the treatment, Morrison says. Step 3.1 states that Customer Service and Sales department shall inform Quality Assurance department of any complaint and shall provide pertinent information to allow QA to perform investigation. In addition, step 3.4 states Quality Assurance shall record, review, investigate and close product complaints. However, you failed to follow this procedure. Questions Post Question There are no questions yet for this company. PAYMENT RECEIVED BY FOR 36 - MOTION OR OTHER (NOT 1ST) PAPER REQUIRING A HEARING, 210 - COURT REPORTING SERVICES IN CIVIL PROCEEDINGS LASTING UNDER 1 HOUR IN THE AMOUNT OF 90.00, TRANSACTION NUMBER 11254996 AND RECEIPT NUMBER 11078888. All complaints are forwarded directly to the Chief Compliance Officer (CCO) of Liveyon LLC/Liveyon Labs for logging into the Liveyon LLC complaint system prior to routing to Liveyon Labs QA for logging into the Liveyon Labs complaint system, which initiates the investigation.