If these products have any effect on patients, Fortier said, its not through live cells or growth factors.. endobj <>stream 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. Elaine Dilley, her mother, and the other two Brazoria County patients feel they were deceived. FDA officials said the agency lacks the resources to pursue a comprehensive crackdown on the sprawling stem cell industry. His. John Kosolcharoen works as a Chief Executive Officer at Liveyon Pure, which is a Business Services company. Authorities described the takedown as the largest in U.S. history, both in the number of those arrested and the financial scope of the fraud. In real stem cell therapies, we do pay close attention clinically to numbers of stem cells, he says. Public Records Policy. It stated, [I]nitial investigation suggests that contamination occurred before distribution, meaning before the product was shipped to doctors offices. A Laguna Beach psychiatrist and six other Orange County residents have been charged with participating in Southern California health fraud schemes that bilked government insurance programs of more than $125 million, prosecutors said Wednesday. In all, 22 defendants face federal charges in Santa Ana and Los Angeles as part of a nationwide sweep involving 301 people accused of falsely billing $900 million, the U.S. attorneys office said. Everyone else in the waiting room, she recalls, started to discuss all the wonderful things they had heard about stem cells. 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. Compounding pharmacies formulate personalized medicines, but prosecutors said those involved prepared formulas aimed at the highest possible profit, not maximum effectiveness. 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. Gaveck assured Herzog the product was sterile, he said. So when they go to these places to get these unproven therapies, they want to believe that they are going to benefit from it. California stem cell company, Liveyon, halts sales of product after 264]. He will be arraigned July 18. (b)(4) vials were distributed without any environmental monitoring data demonstrating control of the immediate manufacturing environment. And You Thought Feral Hogs Were Bad. On Sept. 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. 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., Were a victim as much as the patients who were infected, Liveyons founder and chief executive, John Kosolcharoen, said in one of several interviews with The Post. I thought this was perhaps just a one-off adulterated batch, and then we got into it. *T0T0 Bf G ORDER TO SHOW CAUSE RE: DISMISSAL SCHEDULED FOR 03/04/2013 AT 10:00:00 AM IN C12 AT CENTRAL JUSTICE CENTER. This UT Scientist Helped Spare Millions From COVID-19. Finally, one place to get all the court documents we need. john kosolcharoen rolls royce x+r The CDC report revealed a specific risk: bacterial infection. Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. endobj In a twice-weekly column, Conversations With Gin, she would offer a mix of witty musings and household tips, always closing the Wednesday column with a recipefor tater tot casserole, say, or sauerkraut cake. Many scientists say the injections like most stem cell therapies violate Food and Drug Administration rules against marketing unapproved drugs and are potentially dangerous. From January 16, 2019 to May 20, 2019, Liveyon Labs failed to thoroughly investigate 15 sterility failures and batches processed with cord blood units from ineligible donors: i. endobj Its the FDA that stands between us and all of that fraud. Or at least thats what its supposed to do. 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. This practice, which you refer to as (b)(4) processing, is considered high risk and significantly increases the potential for cross-contamination and mislabeling. Leave them blank to get signed up. c. Step 3.4 states that investigations shall be initiated on the day information is received by QA. However, complaint investigations were not initiated on the day of receipt by QA. FDA Warns Liveyon Over Cord Blood Stem Cell Products Courtney strives to lead a healthy lifestyle that includes yoga and not microwaving plastic. There is a legitimate scientific supported use for stem cells, and the promise is legitimate but theyre being abused. That was the case with the lone type of stem cell therapy that has been proven effective, which treats blood disorders. Peter Marks, the head of the FDAs Center for Biologics Evaluation and Research, recently told an audience of health journalists that the agency is playing a game of Whac-A-Mole and focusing on the most dangerous actors in the stem cell industry. 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. Herzog said he injected himself in May after some of his patients asked for cord-blood injections. Laura Beilis a science journalist based in Dallas. MINUTES FINALIZED FOR CHAMBERS WORK 02/05/2013 12:46:00 PM. 7 0 obj I only want high-quality, reputable physicians that are doing good work providing these types of services to the people of Texas, he says. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an IND in effect as specified by FDA regulations [21 U.S.C. The CDC said it had documented a dozen patients who had developed a variety of maladies from the injections, including swollen spinal discs, infected bones and joints, and abscesses in their backs. 3. Meanwhile, the company is planning a rapid expansion. Kosolcharoen still applies that attitude on the court. How Florence ButtNot Her SonLaunched the H-E-B Empire, Jimmy Carters Peanut-and-Egg Taco Made Quite the Impression on San Antonians, The Top 50 Texas BBQ Joints: 2021 Edition. John W Kosolcharoen | CEO,Medical - Mycity.com 8 Liveyon reviews. While the FDA passively allowed stem cell businesses to operate, the Texas Legislature actively sought to further promote them. and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. SILVER SPRING, Md., Dec. 6, 2019 /PRNewswire/ 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 from PR Newswire: https://ift.tt/2rY5rXX via IFTTT (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 DEMURRER TO AMENDED COMPLAINT 12/21/2012 02:00:00 PM. Just ten patients a month with a simple markup of $3,500 per injection, the sales representatives are told, can add $420,000 to a medical practices annual bottom line. 9 0 obj One of the companies is still active while the remaining five are now listed as inactive. Kosolcharoen said he knew nothing about the FDAs findings at Genetech until several months after the June inspection. Failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications, [21 CFR 211.192]. Asked to comment on the case, Gaveck said the phone call occurred before Liveyon had gotten the first reports of bacterial infections in patients. Ive never heard anybody scream like that.. 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. In fact, 90percent of experimental drugs that go into clinical studies because they look promising end up not getting approved. I asked him if anybody else has gotten sick off the stem cells. But those therapies are still being developed; the only FDA-approved stem cell treatment is for blood disorders like leukemia. FDA sends warning to companies for offering unapproved umbilical cord His arraignment was set for July 18. CASE DISPOSED WITH DISPOSITION OF COURT FINDING, CASE DISMISSED WITH DISPOSITION OF COURT-ORDERED DISMISSAL. <>stream Why Does He Get to Make That Call? Starting around 2014, the market exploded, Turner says. Kosolcharoen said he started Liveyon in 2016, after years of working as an entrepreneur in the insurance, real estate and telemedicine industries. Failure to test donor specimens using appropriate FDA-licensed, approved or cleared donor screening tests, in accordance with the manufacturers instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases [21 CFR 1271.80(c)]. Dorothy OConnell, now ninety, still lives by herself. The most recent email I sent to Kosolcharoen some months back did not receive a reply. The scary part is that theres still a lot we dont know about stem cell treatments. The more you pay for something the stronger the placebo effect is., Hernan Lopez, the CEO of Wondery, was at the Q and A and asked Laura, Should the fact that the treatments are cash only be a red flag?, Yes!, Laura responded, but there are patients that have the idea that medical research is too slow. Liveyon was preying on people for whom the promise of a miracle cure from stem cells was their last hope for a better life and they were happy to pay whatever it took. The U.S. Food and Drug Administration (FDA) 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. x+r And its full of great reads, yall. Everyone in the room listened to her story. Providers figured out how to operate just inside the margins or simply ignored the regulations. 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. Background Report for John W. Kosolcharoen 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. is liveyon still in business. He was not new to the art of medical salesmanship. 26S075SIr 321(g)] and biological products as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. Other officials are also cracking down. Bad Batch Podcast Review: A Story of Stem Cells Gone Wrong *T0T0 Bf G He just looked at me, she says. ii. Liveyon's continuing metamorphosis A screenshot from the Liveyon Luma exosomes website. Additionally, 1+ was inaccurately recorded as 1 CFU in the Positive Sterility and EM Log. Liveyon charges doctors $1,800 for a vial it says contains 30 million cells (although not 30 million stem cells), which they sell to patients for $5,000. City Employees Are Heading for the Exits. What do employees say about pay and career opportunities? On a Wednesday afternoon in September 2018, Dilley and her mother arrived at the Houston clinic and, while in the waiting room, chatted with the other patients. E-FILING TRANSACTION NUMBER 4995458 REJECTED. We dont even have a lab yet, Hardy says. In a test of nine products none of them from Liveyon Fortier found that none contained stem cells, or a single live cell of any kind. And the best part of all, documents in their CrowdSourced Library are FREE! FDA sends warning to companies for offering unapproved umbilical cord Then, in 2012, he became aware of a new Houston company called Celltex Therapeutics, which had connections to a South Korean business hed been tracking. 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. A doctor was in the room with Dilley and her mother when she read the text. I had to say something, and I started telling him, Look, have you checked into this? Such licenses are issued only after showing that the product is safe, pure, and potent. If you have any questions, please contact Mr. Cline at (949) 608-4433 or via e-mail. Stem cells were billed as would-be replacement parts, biological shape-shifters that might be transplanted and grow into whatever the body needed. But before charging his patients $1,800 a vial for something that wasnt effective, he said, he decided to try it himself on a painful knee. And, Hardy saw, Liveyon named Genetech as its exclusive supplier. Kosolcharoen said the recent infections will not impede Liveyons success. However, Liveyon Labs does not qualify for any exception in 21 CFR 1271.15, and the products fail to meet all the criteria in 21 CFR 1271.10(a). For those who still want to try stem cells please do your research first.. We were praying. Complaint C-19-001 was received on April 26, 2019, forwarded to QA on the same day, and QA did not commence their investigation until May 1, 2019. ii. Three additional patients in Texas and Maine have filed lawsuits against Liveyon claiming the companys product infected them with bacteria. Such monitoring is only conducted (b)(4) for surface sampling despite the manufacturing of (b)(4) lots per day. %PDF-1.4 Please include a copy of this letter with your initial submission to CBER. Her new podcast Bad Batch, from Wondery, is an extended investigation of the Texas infection outbreak and the pitfalls of the stem cell industry. LIVEYON IRVINE LLC :: California (US) :: OpenCorporates xY[s~W]R&fOR ? The site included a link to an advertisement for the product Genetech was making, with the slick production quality of a Hollywood movie. By the end of the episode, that man is revealed to be John Kosolcharoen, founder and CEO of Liveyon. CASE ASSIGNED TO JUDICIAL OFFICER MOBERLY, JAMOA ON 07/02/2012. 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. 2021-12-17, Pinellas County Courts | Personal Injury | b. There was a man talking to this woman that was sitting next to him, and he started talking about having stem cells done in his knee, she says. It didnt look like my mother, Dilley says. People are making money all along the way., Its difficult to tell exactly how much money is being made in stem cells, but the business is clearly lucrative and fast-growing. Listen to author Laura Beils hit Wondery podcast. Jos R. Ralat is Texas Monthlys taco editor, writing about tacos and Mexican food. (dg) [8:16-mj-00325-DUTY] (Entered: 06/23/2016) Main Doc ument Buy on PACER 4 Jun 21, 2016 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. If you do not agree with these terms, then do not use our website and/or services. Another doctor, the salesman said, had improperly stored the vials. Im like, First customer? To launch the company, he brought on Alan Gaveck, 59, a podiatrist who serves as Liveyons top medical expert. 4 0 obj The CDC did not name the patients, but the date of Luncefords injection and the length of his hospital stay match those of a patient listed in the CDC report. SILVER SPRING, Md., Dec. 6, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration has warned Liveyon Labs Inc. 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. For 58 days, Lunceford remained hospitalized, wracked by intense pain. Before that, Kosolcharoen ran into trouble with the Securities and Exchange Commission. Studies have found that the more expensive a treatment, the stronger the placebo effectand patients are paying thousands of dollars for stem cell treatments. If it would help her mother feel better, she wouldve been prepared to sell her house. But theres nothing inherently magical about placental tissue or the amniotic sac.. Dilley wasnt allowed to ride in the helicopter, so she hurried to her car, stunned at the sudden turn of events. Three more attendees sat in wheelchairs. Failure to establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)]. 262(a)(3); 21 CFR Part 312]. endstream So as to avoid the appearance of speaking out against a private firm, he agreed to help, with one stipulation: he didnt want to know which company the seminar was representing. Sincerely, 262(i)]. 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. 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. They explained that stem cell extractions taken from bone marrowthe chief competition for the umbilical stem cell marketcontain far fewer actual stem cells than Liveyons product. I had a very busy surgical practice and, yes, I had a malpractice suit, Gaveck said in a telephone interview. The case status is Not Classified By Court. 5. <>>>/StructParents 0/Contents 4 0 R/Parent 5 0 R>> SILVER SPRING, Md.The U.S. Food and Drug Administration (FDA) has warned Liveyon Labs Inc. and Liveyon LLC, of Yorba Linda, Calif., and their president and chief executive officer, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. Dear Ms. Panah and Mr. Kosolcharoen, During the inspection of your firms Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, co-located at 22667 Old Canal Road, Yorba Linda, CA 92887, conducted . During the seminar, the presenters walked through the science as they understood it. During the inspection of your firms Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, co-located at 22667 Old Canal Road, Yorba Linda, CA 92887, conducted between May 13, 2019 and May 23, 2019, the Food and Drug Administration (FDA) documented that Liveyon Labs processes human umbilical cord blood derived cellular products PURE and PURE PRO for allogeneic use (hereinafter, umbilical cord blood products or products). c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. Rose Cahalan is an associate editor who focuses primarily on stories about travel and the outdoors. 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. x+r Genetech closed shortly thereafter. FDA Sends Warning to Companies for Offering Unapproved Umbilical Cord <>>>/Type/XObject/Subtype/Form/BBox[0 0 612 792]/Matrix[1 0 0 1 0 0]/FormType 1>>stream Their leader John Kosolcharoen? Patients are offered a miracle cure, but instead they end up rushed to the hospital in critical condition. 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. Williamson had pain in her back. Website: www.liveyon.com Headquarters: Irvine, CA Size: 51 to 200 Employees Type: Company - Private Revenue: Unknown / Non-Applicable Competitors: Unknown 3.4 4 Ratings "Great" Nov 26, 2021 - Sales Associate Advice to Management Keep up the good work Diversity & Inclusion at Liveyon ( 2 Reviews) Liveyon Interviews Experience Positive 100% I obtained an internal training call for its sales force, in which representatives are instructed to remind doctors that the vial can be used for more than one injection on the same patient$5,000 for one knee, with a discount price of $2,500 for the second kneeincreasing the doctors markup to $5,700 for a couple of quick procedures. Discovery Regional Sports Networks May File For Chapter 7 Bankruptcy, Accused And Poker Face Forging New - And Old - Broadcast TV Path, Fox News Host Says Network Wont Let Him Cover Dominion Lawsuit. Then, of course, I knew it was Genetech, and I said, Oh, crap. He was surprised not that something disastrous had happened but that Genetech had moved forward at all. But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. Liveyons product contained 300,000. Why Doesnt Elon Musk Fund Twitter Until It Turns Around? The .gov means its official.Federal government websites often end in .gov or .mil. Contact plates are not an appropriate substitute for settling plates, as they are intended to recover organisms through direct contact with surfaces and not passive air sampling. Based on this information, we have determined that your actions have violated the FD&C Act and the PHS Act. Download (Generally speaking, the FDA has stipulated that human tissue can be used in patients so long as it is minimally manipulateda skin graft, for instanceand is intended for homologous use, meaning the extracted tissue serves the same function in the patients body as it would in the donors body.) He tried to set up a video conference to discuss the problem, but it never happened. What is it really like to work at Liveyon? After Gin Crawford mentioned his clinic in her column and he bought the ad in the Brazosport Facts, more patients began driving up from Brazoria County. ADDITIONAL LINKS Post Question For This Company Contact Us Regarding Your Company Profile Search All California Companies The patient sued Gaveck for malpractice, he said; he later decided not to renew his medical license. She was so pale that her skin looked almost translucent. endobj JOHN W KOSOLCHAROEN, chief executive officer; MARC ASHEGHIAN, agent; Registry Page https://bizfileonline.sos.ca.gov/sear. 34-73378; File No. MINUTES FINALIZED FOR EX PARTE 08/02/2019 08:30:00 AM. In June about the time Liveyon first started hearing from providers about infected patients an FDA inspection of Genetechs facility found numerous sterility and safety lapses, according to FDA records. Another LinkedIn search by the Liveyon company name found many apparent employees so maybe they are still active in the umbilical cord space? endstream Seven months after his July injections, Lunceford, the patient from Athens, Tex., said he still experiences persistent stabbing pains and has been unable to return to work. Loren Elliott/The Washington Post via Getty. DECLARATION RE: EX-PARTE NOTICE FILED BY LIVEYON, LLC ON 08/01/2019, PROOF OF ESERVICE FILED BY LIVEYON, LLC ON 08/01/2019, PROOF OF SERVICE BY MAIL FILED BY LIVEYON, LLC ON 08/01/2019, DECLARATION FOR WRIT OF EXECUTION/POSSESSION/SALE FILED BY LIVEYON, LLC ON 08/01/2019, MEMORANDUM OF POINTS AND AUTHORITIES FILED BY LIVEYON, LLC ON 08/01/2019, EX PARTE APPLICATION FOR WRIT OF POSSESSION FILED BY LIVEYON, LLC ON 08/01/2019. Because the umbilical cord blood products are not intended to perform the same basic function or functions of umbilical cord blood in the recipient as in the donor, such as forming and replenishing the lymphohematopoietic system, using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c). Liveyon LLC | LinkedIn But he has an explanation for why they were in such a hurry to get started. I talk about what I know and the science of it.. State representative Tan Parker, a Republican from Flower Mound, says he became interested in stem cells because his wife suffers from lupus. Host and researcher Laura Beil expanded the basic news story to look at the science and regulation behind stem cells and explain it in an easy to understand way. While the two sat in John's office one afternoon, the good news arrived: After two years of hard work, compliance for Liveyon . Her kidneys were shutting down, and they were worried she was going to have a heart attack, Dilley said. They are already aggressively marketing vials being produced by their new lab under the label Liveyon Pure and have increased their asking price by $200 a vial. 26S075SIr 'Miraculous' stem cell therapy has sickened people in five states AMENDED COMPLAINT DISPOSED WITH DISPOSITION OF COURT-ORDERED DISMISSAL. I did more research into what I was just told and didnt find the answers that I liked, he says. As Laura pointed out, we dont know whose a good candidate and we dont know whats a safe treatment. d. Liveyon Labs failed to accurately record the number of colony-forming units (CFUs) for each positive settling plate: i. 355(i); 42 U.S.C. Cases involving other real property matters not classified elsewhere. WELLS FARGO BANK, N.A. By mid-December, the CDC had found 12 patients, its report said: seven in Texas, four in Florida and one in Arizona. That firm had previously received an FDA warning letter and has since ceased operations after a series of lawsuits. I took an audio recording I made in Sulphur Springs to Sean Morrison, of UT Southwestern. Almost immediately, says Kirstin Matthews, a fellow at Rice Universitys James A. BakerIII Institute for Public Policy, we saw all these big, huge advertisements start popping up around the state and newspapers, TV ads, billboards promoting all kinds of stem cell interventions.. During this time period, donors tested positive for ZIKV, Hepatitis B, and syphilis. The Federal Trade Commission has targeted some clinics for making false claims. Feeling better means more to me than money, Crawford wrote, and Dilley agreed. 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. 'Miraculous' stem cell therapy has sickened people in 5 states But OConnell had severe arthritis, and doctors could do little to help her. H-E-Bs True Texas BBQ Restaurant Is Slipping. 14 0 obj 12 0 obj Defendant John Kosolcharoen is directed to appear for Preliminary Hearing on 7/12/16 at 4:30 PM and for Post Indictment Arraignment on 7/18/16 at 10:00 AM before the Duty Magistrate Judge. Dr. Samuel Albert, 81, of Laguna Beach, a psychiatrist who operated an office in Fountain Valley, charged on Tuesday with conspiring to commit health care fraud. Eventually, researchers say, stem cells could be used to treat many diseases, including macular degeneration, diabetes and Parkinsons. 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. I played him the tape of the claim about the 2,500 stem cells versus the 300,000. Last month, Los Angeles health officials reported two patients had become seriously ill after being injected with a similar product sold by a different company.