liveyon ceo john kosolcharoen
But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. 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. Doctors and more specifically dermatologists? iv. Liveyon Founder and CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck discussed the differences on 'Pure-Cast' with stem cell experts, Dr. Margaret Coutts, Chief Scientific Officer for Liveyon and Dr. Rafael Gonzales, a prominent industry expert.. Failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)]. 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. 2. 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"We see fraudulent testing, where companies had a test done and then we found fraudulent documentation and tweaking of some of the numbers to make themselves look better," Kosolcharoen said. For Lois, the next few years looked worrisome. 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 an extremely consistent product for the most efficacious outcomes. 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. Dr. Gaveck brings 13 years of experience in both clinical and surgical medical treatments and the two hosts' intellectual chemistry enhances the show's format, as they tackle groundbreaking topics and introduce experts in the field of regenerative medicine, including leading researchers and physicians. Please check your inbox or spam folder now to confirm your subscription. While already suffering from severe arthritis, Lois tore her ACL/MCL meniscusleaving her not only with excruciating pain but the thought of being wheelchair-bound for the rest of her life. The company's dynamic ability to adapt to changing market trends and execute on opportunities has fortified its exponentialgrowth and the company is poised to continue making a huge impact in the industry 2019. 6. Its all about informed consent but people arent getting it, she says. TRICARE paid hundreds of millions of dollars for creams for minor pain, scars, erectile dysfunction or general wellness, prosecutors said. I think they're the way of the future, and I think regenerative medicine has a huge place in our aging population. from 8 AM - 9 PM ET. Most of the Southern California cases stemmed from a compounding pharmacy scheme targeting TRICARE. 355(i); 42 U.S.C. No corrective actions were implemented, and four impacted in-process batches were subsequently distributed. In fact, the FDA has said it will further investigate and enforce regulations of stem cell companies in November 2020. The company's dynamic ability to adapt to changing market trends and execute on opportunities has fortified its exponentialgrowth and the company is poised to continue making a huge impact in the industry 2019. The firm's owner, entrepreneur John Kosolcharoen (pictured from a video), as well as the patients and families harmed by a contaminated Liveyon product are the main real-life characters in this story. 4. Im not aware of firms in this space having such approval at this time. Save my name, email, and website in this browser for the next time I comment. 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. 262(a)]. To stay up-to-date on the regenerative medicine industry and receive notices of free upcoming live streaming video events, please subscribe to 'Liveyon Pure-Cast. For the full transcription of the show follow the link: 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. month to month. 262(a)(3); 21 CFR Part 312]. Unfortunately, theres evidence that 90 percent of drugs that go into clinical trials dont work and the general public is often misled by slick advertising that often uses exaggerated or misleading claims. A woman named Lynne B. Pirie, a former D.O. "I said 'I have the least amount to lose, I'm the oldest and I believe this product is 100 percent pure,'" Lois recalled on the podcast. GODSPEED. c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. You processed cord blood units from ineligible donors and destroyed the final product batches from donors who tested positive for relevant communicable diseases without conducting an investigation. And beyond all the science and the explanations, theres the story of the man behind it all. if I hire a contractor to do specific work as agreed and he / she goes rogue on our agreements I am floored and discontinue / fire that contractor. Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)]. The umbilical cord products are not the subject of an approved BLA nor is there an IND in effect for your products. Include any documentation necessary to show that correction has been achieved. In a letter to clients, Liveyon LLC Chief Executive Officer John Kosolcharoen said the company has halted distribution of its products, Pure and Pure Pro, to "focus its efforts" on getting. . 3. 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. In addition, you failed to use FORM-LL-037 to formally initiate and document your investigation. In fact, if you read their clinical support closely and do a little homework, you will understand the gimmick. YORBA LINDA, Calif., April 9, 2019 /PRNewswire/ -- In a recent episode of the Liveyon 'Pure-Cast,' John Kosolcharoen, founder and CEO of Liveyon, and Dr. Alan Gaveck, Director of Education, examined the state of the regenerative industrybreaking down some of the most pressing problems plaquing the stem cell field and offering real solutions. Dr. Gaveck brings 13 years of experience in both clinical and surgical medical treatments and the two hosts' intellectual chemistry enhances the show's format, as they tackle groundbreaking topics and introduce experts in the field of regenerative medicine, including leading researchers and physicians. She eventually moved on to other jobs and raised a son.. You processed cord blood units from ineligible donors and destroyed the final product batches from donors who tested positive for relevant communicable diseases without conducting an investigation. b. 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. 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. Its also not exosomes but conditioned medium containing fetal bovine serum that is going to kill someone. Despite (b)(4) processing (b)(4)% of your cord blood units, your investigations failed to extend to the (b)(4) processed batches. Who is Liveyon. d. Liveyon Labs failed to accurately record the number of colony-forming units (CFUs) for each positive settling plate: i. Yorba Linda, CA 92887 Conformis, Inc., Bodycad Laboratories, Inc., and Bodycad USA Corp. have resolved their patent litigation. Lauras advice for people who are desperate for something to happen is to join a clinical trial where you are monitored by doctors with an expected outcome. Seven from O.C. Theyve thrown the buzz phrase nanoparticles in there too. For further information about IND requirements for biological products, contact the Center for Biologics Evaluation and Research (CBER), Division of Regulatory Project Management, Office of Tissues and Advanced Therapies, at (240) 402-8190, or OTATRPMS@fda.hhs.gov. 5. This is obviously a smear campaign. Ive included here one screenshot of the type of marketing on their website that has come to be associated with the firm at right. 844-548-3966 During this time, (b)(4) vials of umbilical cord blood products were manufactured and subsequently distributed. Specifically, Liveyon Labs tested (b)(4) umbilical cord blood donors for ZIKV with a test that was not FDA licensed, approved, or cleared for HCT/P donor screening. The bulk of the show is about John Kosolcharoen, the charismatic CEO of Liveyon, an ambitious stem cell company that raced ahead of existing research to provide cure-alls to patients who. The root cause and source of the contaminating organisms was not identified. They are in it for a quick buck. Dont fund their greed. My guess is that FDA is keeping very close tabs on the perinatal space these days. I call it an unheard of A+++ endorsement as of last May 2019 . Three of the five settling plates were positive for P. glucanolyticus. In addition, you failed to use FORM-LL-037 to formally initiate and document your investigation. 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). Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process. Los Angeles' top dermatologist, Dr. Ben Behnam, joined Liveyon CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck on the latest episode of Liveyon Pure-Cast for an in-depth . Why did Duke autism team halt its troubling pay-for-play program? The study utilized (b)(4) vials per batch, however batches were observed to be manufactured with up to (b)(4) vials. 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. Weekly reads: reprogramming hearing loss, heart disease, eye drops, sickle cell, Questions on National Academies in vitro gametogenesis (IVG) meeting sponsorship, Weekly reads: FDA nod on new cell therapy, gray hair, pong-playing cells. Program Division Director Despite (b)(4) processing (b)(4)% of your cord blood units, your investigations failed to extend to the (b)(4) processed batches. more and more 24/7. Liveyon CEO John W. Kosolcharoen believes that while the stem cell industry has made impressive strides in recent years, a key element in advancing regenerative applications for cord blood going forward will be thorough characterizations that describe the cell preparation and composition of products in greater detail. Dr. Gaveck brings 13 years of experience in both clinical and surgical medical treatments and the two hosts' intellectual chemistry enhances the show's format, as they tackle groundbreaking topics and introduce experts in the field of regenerative medicine, including leading researchers and physicians. He will be arraigned July 18. We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations and prevent their recurrence. In order to market them in a compliant way you must have prior FDA approval. Like many companies, profit comes first. I dont know what this all means from a regulatory perspective. His arraignment was set for July 18. Join hosts, Liveyon CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck, for this exclusive live podcast series, broadcast streaming live on the Liveyon Pure Cast podcast channel every Monday, Wednesday and Friday morning. For example, Liveyon Labs deficient donor eligibility practices, inadequate aseptic practices, and deficient environmental monitoring, as described below, pose a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects. "You know stem cells are real. "Within a month or six weeks, I was walking pain-free two to three miles a day, and it just increased from there," Lois said. Their leader John Kosolcharoen? "Within a month or six weeks, I was walking pain-free two to three miles a day, and it just increased from there," Lois said. LIVEYON could not monitor GENETECH (3rd party mfg 24/7 and trusted NOT to have to medically speaking) As all companies cannot monitor the QC of the third party mfg as you have to have a level of trust that ethically that they are keeping the agreed contractual formulation day to date . Are autoimmune or stem cell transplant patients at higher risk from COVID-19? John blamed the doctors who purchased the stem cells from him for improper handling of the vials even though the FDA didnt share his conclusions. b. The Orange County defendants were accused of crimes that involved billing Medicare for occupational therapy that was never provided, submitting false patient reports for state workers compensation and paying kickbacks for expensive prescriptions that were billed to TRICARE, the militarys insurance plan. He has signed a plea agreement stemming from allegations that he billed workers comp for $4.2 million between 2008 and 2014 from fraudulent patient reports based on templates with copied and pasted information. FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. 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. 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. Strikingly, 19 out of these 20 patients required hospitalization. Postal Service. You have one central character, the industry itself, the science of it, and the regulations.. Courtney strives to lead a healthy lifestyle that includes yoga and not microwaving plastic. b. She was queasy when she watched surgery for the first time (a knee replacement) especially when a drop of blood splattered in her notebook! 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. 2. What about in our country? 9. 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. Sitemap Privacy Policy, Winner of the MORE Award in Journalistic Excellence in Orthopedics. Maybe, maybe not. Get Email Address. Please check your inbox or spam folder now to confirm your subscription. As stated above, because your products do not meet all the criteria in 21 CFR 1271.10(a), and Liveyon Labs does not qualify for any exception in 21 CFR 1271.15, the products are regulated as drugs as defined in section 201(g) of the FD&C Act [21 U.S.C. 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 . For those who still want to try stem cells please do your research first.. You are really reaching for straws to try and and slander Liveyon. In addition, you failed to track which batches have been processed (b)(4) potentially failing to identify contaminated umbilical cord blood product if one of the batches failed sterility or was processed using cord blood from an ineligible donor. the doctors / patients using LIVEYON did not abandon their use and even the FDA recent spring of 2019inspections witnessed LIVEYON excelling and delivering MORE than ever actually expected &/or required. just faithfully (after this better reformulation and transformation) better extend patients lives doing what they wanna do . 262(i)]. DUH!!! The exclusive video series streams live every Monday, Wednesday and Friday morning and featuresJohn Kosolcharoen, founder and chief executive officer of Liveyon and Dr. Alan Gaveck, director of education, Liveyon. 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)]. (b)(4) used in association with the (b)(4) to remove the red blood cells from the umbilical cord blood. 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)]. For example: a. The CDC team also used next-gen sequencing to determine that all of the contamination likely originated from one source. To stay up-to-date on the regenerative medicine industry and receive notices of free upcoming live streaming video events, please subscribe to 'Liveyon Pure-Cast. Remember our old friends Liveyon? United States. An archive of the site homepage from last year didnt mention exosomes. 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. They found that 20 patients in 8 states got bacterial infections after injections with the product. During this time period, donors tested positive for ZIKV, Hepatitis B, and syphilis. 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. Her appeal was denied on December 24, 2010. Department Finance . Geez. All Rights Reserved. That stem cell thrust ultimately landed a dozen or more people in the hospital as some of the product was somehow contaminated with bacteria along the way before injection in patients. But, just as John was there for his mother when she suffered her knee injury, she was there for him, too. The route of administration for the umbilical cord blood products includes intra-articular injection. Founded in 2016, Liveyon is pushing the boundaries of regenerative medicine with its innovative take on product research and development, manufacturing and distribution, and commitment to safety and transparency. A new film-commercial entitled Awakening pitches unproven exosomes and has already been possibly tied to the troubled stem cell supplier firm Liveyon, but now it seems that the links go far deeper including a possible relative of Liveyon leader John Kosolcharoen.. Who are the intended customers here? We recommend that you review the violations listed above, consider the potential serious risks to patients your manufacturing violations present, and consult with third-party experts to implement comprehensive corrective action. Just over a year ago another supplier, Predictive Technology, also got a warning letter. Weekly reads: Sarepta, epigenomics, FDA on eyedrops, 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. This practice, which you refer to as (b)(4) processing, is considered high risk and significantly increases the potential for cross-contamination and mislabeling. The CFUs for lot number (b)(6) were noted as too numerous to count (TNTC) in the raw environmental monitoring data, however it was recorded officially as 1+ CFUs in the In-Process EM Data and 1 CFU in the Positive Sterility and EM Log. YORBA LINDA, Calif., April 9, 2019 /PRNewswire/ -- In a recent episode of the Liveyon 'Pure-Cast,' John Kosolcharoen, founder and CEO of Liveyon, and Dr. Alan Gaveck, Director of Education, examined the state of the regenerative industrybreaking down some of the most pressing problems plaquing the stem cell field and offering real solutions. Although still an experimental industry, Dr. Behnam has seen unprecedented success treating hair . If you recall all those gold rushers in the Wild Wild West of our CA gold rush . A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. For example: a. This is the American come back stronger story that you are proud to back and renew your trust accordingly . Specifically, the Liveyon Labs SOP LL-LAB-004v1, entitled PURE Product Production, failed to assure that the (b)(4) containers used during the manufacture of approximately (b)(4) batches of your products between January 16, 2019 and May 20, 2019, did not alter the final product identity, strength, quality, and purity. 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.