You have one central character, the industry itself, the science of it, and the regulations.. 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. Whats your interest? For those who still want to try stem cells please do your research first.. 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). "You know stem cells are real. The way I see it is simple . 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. Seriously. [Suppling food, equip, tools, explosives, etc., etc{ to help the guy Work/ extend / live his/her dream as they choose. But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. 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)]. 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. 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. Chief Executive Officer at Liveyon LLC. 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. Comparing the industry to the housing market, Kosolcharoen agreed a bubble does exist due to emerging companies in search of a profit at the cost of cutting regulatory corners. 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. Department Finance . Your complaint procedure LL-QA-015, entitled Product Complaint is not followed and is inadequate: a. Another issue raised in their warning letter that applies more broadly in some cases is that umbilical cord cell products are defined as drugs by the FDA. Another LinkedIn search by the Liveyon company name found many apparent employees so maybe they are still active in the umbilical cord space? 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. Orthopedics Spine Surgeon or Neurosurgeon, Is There a Difference? Not intended for diagnostic or therapeutic procedures.. Sincerely, Remember this 2017 to date has been part of the very WILD WILD WEST of stem industry in AMERICA initially. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? The new epidemiological study in JAMA Network Open reports on a number of aspects of the large adverse event. I think they're the way of the future, and I think regenerative medicine has a huge place in our aging population. Run from this company. United States. "You know stem cells are real. A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. 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. http://www.prnewswire.com/news-releases/mother-of-liveyon-ceo-shares-heartfelt-stem-cell-success-story-with-son-on-pure-cast-podcast-300827743.html. Since manufacturing operations began in (b)(4), you (b)(4) processed (b)(4)% of your (b)(4) batches. 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. 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. The key difference here from their past products is that this is apparently a cosmetic product rather than something intended for injection IV. It is unclear what that means, and whether it is a response to the adverse events related to Genetechs products, he said. Dr. Gaveck brings 13 years of experience in both clinical and surgical medical treatments and the two hosts' intellectual chemistry . Ive been writing about medicine for 25 years, Laura says, and the placebo effect is powerful. but made them FAR BETTER EQUIPPED FOR REGENERATIVE FUTURE because they did the right thing when this all came to light. She also played a major part in the rollout of Liveyon's Peer Series. Such actions include seizure and/or injunction. Courtney strives to lead a healthy lifestyle that includes yoga and not microwaving plastic. Although still an experimental industry, Dr. Behnam has seen unprecedented success treating hair . The number was actually much higher it seems, based on a new report. 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. The podcast provides a complimentary resource for clients of the company's new product line. A woman named Lynne Pirie of Phoenix, Arizona, has identified herself online, in LinkedIn and in postings defending the company on blogs, as the Territory Manager Southwest USA for Liveyon since August 2018, and says she has a Doctor of Osteopathy degree from the University of Michigan. Several other firms seem to be actively supplying materials to customers. The company's dynamic ability to adapt to changing market trends and execute on opportunities has fortified its exponential growth and the company is poised to continue making a huge impact in the industry 2019. 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. "I think all of those things will catch up to the industry and the FDA is going to have to come in and put some type of heavy regulation it.". But Lois' connection to Liveyon doesn't end with her remarkable recovery, as she continues to be an integral support system for John as a CEO and for the company. Their leader John Kosolcharoen? Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. Yorba Linda, CA 92887 We dont see too many people defending this firm. Please check your inbox or spam folder now to confirm your subscription. Liveyon's continuing metamorphosis A screenshot from the Liveyon Luma exosomes website. She grappled with the idea of how major surgery and years of physical therapy could still leave her reliant on canes and walkers. ii. For example: a. FDA has identified Zika virus (ZIKV) as a relevant communicable disease agent or disease (RCDAD) under 21 CFR 1271.3(r)(2). YORBA LINDA, Calif., April 9, 2019 /PRNewswire/ -- Breaking from the traditional format of Liveyon's live 'Pure-Cast,' Liveyon founder and CEO sat down with his mother, Lois Christianson, in a heartfelt conversation on how stem cell treatment saved her life after a horrifying injury. Despite (b)(4) processing (b)(4)% of your cord blood units, your investigations failed to extend to the (b)(4) processed batches. Strikingly, 19 out of these 20 patients required hospitalization. She also played a major part in the rollout of Liveyon's Peer Series. ii. Kosolcharoen brought light to companies conducting fraudulent testing and doctoring numbers to enhance their brand while promoting a faulty productand called for manufactures to take more responsibility. Based on this information, we have determined that your actions have violated the FD&C Act and the PHS Act. In a second round of questions, we asked Liveyon through an outside spokesman whether the two individuals in company management and the two named in these legal actions were the same people. 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)]. A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. the kind that should due you in are the very opportunity area to be better than ever before to overcome. Orthopedic surgeon Paul Mason, M.D. Insiders Provide Real Solutions to the Tough Problems Plaguing the Industry. The medical board alleged at the time that she had engaged in many instances of prescribing HGH for improper purposes. Even so, Kosolcharoen (pictured with another Liveyon leader Alan Gaveck below in a web video) recently denied involvement in an . The scary part is that theres still a lot we dont know about stem cell treatments. Thank you, JOHN K. / LIVEYON as I knight thee in becoming a very much need national and world MOST trusted UCB stem source .. the Phoenix from the flame rarity or rare kind . Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process. from 8 AM - 9 PM ET. 22667 Old Canal Road LIVEYON was a victim of this hurrendous negative as much as those innocent patients that got the bacteria were. The ultimate podcast show featuring hosts, Liveyon CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck, discussing Liveyon's new product offerings and the most controversial, popular and relevant stem cell regenerative medicine topics. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Doctors and more specifically dermatologists? This is the American come back stronger story that you are proud to back and renew your trust accordingly . Released immediately on bail, he was due to be sentenced on February 13, 2017, but has had several continuations, the most recent from January 28 of this year to September 30. Liveyon does NOT distribute or provide "stem-cells"!! 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. He has signed a plea agreement and is awaiting a hearing. Dr. Death was a brilliant series about a rogue doctor that was unqualified at his job and made a lot of bad decisions that injured or killed many people. But Lois' connection to Liveyon doesn't end with her remarkable recovery, as she continues to be an integral support system for John as a CEO and for the company. ', Media Contact:James Buzzacco844-548-3966[emailprotected], Cision Distribution 888-776-0942 For example: a. Liveyon Labs failed to conduct surface and active air environmental monitoring from January 20 to February 16, 2019. The .gov means its official.Federal government websites often end in .gov or .mil. Listen to Bad Batch. Glad to read this smearing review. more and more 24/7. b. The route of administration for the umbilical cord blood products includes intra-articular injection. 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 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. 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. Your firm did not implement corrective or preventive actions. 355(i); 42 U.S.C. The DT-001 Form 1 Recovery Site Assessment received from cord blood supplier (b)(4) did not adequately assess a donors residence in, or travel to, areas identified by the Centers for Disease Control and Prevention with active ZIKV transmission. 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. Now it seems to me that they are marketing an exosome cosmetic product called Luma. Many successful companies have alot to overcome at certain points but its those very AMERICAN failure issues . that have been on the market for a long time. 3. You folks should have better things to do. d. Liveyon Labs failed to accurately record the number of colony-forming units (CFUs) for each positive settling plate: i. 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)]. Her license to practice as a doctor of osteopathy was revoked. Maybe, maybe not. While bone marrow procedures were once known as a scientific breakthrough, Dr. Gaveck explains how new technology and discoveries have . 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]. 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. 844-548-3966 Really Paul? Learn how your comment data is processed. We recommend that you review FDA Guidance for Industry, Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (updated May 2018), available at https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm488582.pdf. Use and abuse and discard. 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. For example: a. FDA has identified Zika virus (ZIKV) as a relevant communicable disease agent or disease (RCDAD) under 21 CFR 1271.3(r)(2). Seven from O.C. THEY did right by the patients and doctors in every way possible the moment light dawned as they knew they were conned / shortchanged (label it as you please) as the six figure payments paid for that exclusive proprietary specific formulation of was NOT as LIVEYON agreed or contractualized .. it was GENETECH who went rogue. The umbilical cord products are not the subject of an approved biologics license application (BLA) nor is there an IND in effect. 9. She loves writing about public health issues as well as the courage and resilience of patients facing illness. /S/ 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. The actual website has some more risqu images. We also acknowledge the other corrective actions you have taken in response to the observations. 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. LIVEYON allows science to speak the results for itself. "I think there is a stem cell bubble," Kosolcharoen said on the show. 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. This is a BETA experience. For example, the following components were not tested before release: a. Complaint C-19-003 was received on March 7, 2019, forwarded to QA on the same day, and QA did not commence their investigation until May 1, 2019. "As the CEO and founder of Liveyon and Liveyon labs, I said 'of course I want to be the first person that tries the new product, I'll take the first flagship injection,'" Kosolcharoen said at the time. However, the response does not provide sufficient detail to fully assess the adequacy of your corrective actions to date and lacks copies of any updated procedures or additional documents to demonstrate that you have corrected the deficiencies noted in the inspectional observations. By the nature of their routes of administration, your products purport to be sterile and are expected to be sterile. These containers are labeled For research use only. While the two sat in John's office one afternoon, the good news arrived: After two years of hard work, compliance for Liveyon's Peer Series was complete and it was ready to launch. (b)(4) used in association with the (b)(4) to remove the red blood cells from the umbilical cord blood. 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. He will be arraigned July 18. 5. For example: a. Required fields are marked *. But if something is wrong, we can't afford to lose our CEO, so I'll be first.". While regenerative medicine is still an experimental field, Liveyon has been a pioneer in the stem cell industry and manufacturer of thehighly acclaimedLiveyon Pureregenerative therapy umbilical cord stem cell product line. Failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)]. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Just over a year ago another supplier, Predictive Technology, also got a warning letter. 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). 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. iii. Geez. Liveyon Labs relied on such tests, which is not appropriate to prevent the introduction, transmission, or spread of ZIKV through HCT/Ps. 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 Buffalo Bone and Joint, PLLC have filed a $24.7 million lawsuit. agreed to be banned from selling securities, https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm488582.pdf, Orthopedic Surgeon Sues NY Health System for $24.7M, Ortho Surgeon Whistleblowers Sue Erlanger Health System, Treace Medical Concepts and Fusion Orthopedics Reach Settlement, 510(k) Clearance for Femur Fracture Fixation Nailing System, 510(k) Clearance for Web-Based Orthopedic Planning Solution, Conformis and Bodycad Settle Patent Dispute, Welcome to our Master Class on Lumbar Total Joint Replacement, History of the Fernstrom Ball, BAK and Spine-Tech, 4WEB Sues NuVasive for Alleged Patent Infringement, 5,153 Patient THA Study Finds 2.8x Revision Racial Disparity, SurgiSTUD: A New Gold Standard for Surgical Training, One Consistently Top Ranked Spine Meeting. They also say the product is acellular, so I guess they are forging ahead without a stem cell focus, at least with Luma? "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. 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. 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. 262(i)]. 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. 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. She eventually moved on to other jobs and raised a son.. The exclusive video series streams live every Monday, Wednesday and Friday morning and features John Kosolcharoen, founder and chief executive officer of Liveyon and Dr. Alan Gaveck, director of education, Liveyon. Compounding pharmacies formulate personalized medicines, but prosecutors said those involved prepared formulas aimed at the highest possible profit, not maximum effectiveness. I call it an unheard of A+++ endorsement as of last May 2019 . 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)]. reduced to how many come end of FDA 36 month roll out this Nov 2020??? 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. During this time, (b)(4) lots were manufactured, totaling (b)(4) final product vials. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed. His arraignment was set for July 18. The CEO of Liveyon LLC, which is headquartered in Yorba Linda in Southern California, is a man named John W. Kosolcharoen. b. Liveyon spent a million dollars on a commercial seminar for doctors who were pitched on how much money they could make and then given a script of exactly what to say to patients. The study utilized (b)(4) vials per batch, however batches were observed to be manufactured with up to (b)(4) vials. 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. 262(a)(3); and 21 CFR Part 312]. from 8 AM - 9 PM ET. TRICARE paid hundreds of millions of dollars for creams for minor pain, scars, erectile dysfunction or general wellness, prosecutors said. 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. 262(i)]. 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. 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). Its also notable that the FDA, even if not their CBER branch, has taken enforcement action on stem cell cosmetics in the past and could do so again. The deficiencies include, but are not limited to, the following: 1. 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. 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 conversation on common misconceptions, scientific breakthroughs and popular issues surrounding hair regeneration. 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. 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. The FDA has granted 510(k) clearance to a web-based medical image management and processing system. For the full transcription of the show follow the link: "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. ', Media Contact:James Buzzacco[emailprotected] 844-548-3966, Cision Distribution 888-776-0942 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. Nor did you commit to providing any follow-up response(s) to address any corrective actions once implemented. Liveyon LLC was incorporated on June 13, 2016. arrested in nationwide health, Click to share on Facebook (Opens in new window), Click to share on Twitter (Opens in new window), Click to share on Reddit (Opens in new window), Seven from O.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. Its a topical cosmetic product. 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. Since exosomes are drug products, its not clear to me at least that you can market them as a cosmetic without approval. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? as pain free as possible so each and every one can have their quality of life back long after normal limitations as they each regenerate inside out as GOD designed us all to do all along. Therefore, review of relevant medical records, as defined in 21 CFR 1271.3(s), must indicate that a potential donor is free from risk factors for, or clinical evidence of, ZIKV infection for the purpose of determining donor eligibility.