Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. *DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Required fields are marked *, I am worried! It is a member of the Be The Match Program and has passed all FDA inspections. However, in products that are shipped around the country from a single manufacturing site, if a batch becomes contaminated, many, many people can be harmed with one error. Liveyon, a company in Yorba Linda, Calif., sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. However, realize that outside of that free online registration form, the FDA may or may not have ever inspected or reviewed how Liveyon was being manufactured. 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. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you. In fact, the FDA doesn’t review the information at all other than noting an address where it may inspect the lab for the right type of processing techniques and cleanliness. If one of these products ends up being given that way, this would lead to sepsis and possible death. Liveyon has since ceased distribution of the stem cell products and has issued a recall for those already in circulation. Sincerely Yours, John W. Kosolcharoen Founder/CEO Liveyon LLC, Media Contact Erin Sairafe [email protected] 800-578-0983. Liveyon has since ceased distribution of the stem cell products and has issued a recall for those already in circulation. As of December 14, CDC has received reports of infec- Most of these companies that sell these tissues don’t manufacture them or do any science, but rather are just marketing outfits. Liveyon marketed and distributed these products under the trade name ReGen Series®. Safety Alerts, An official website of the United States government, : All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Meaning a complaint was logged and the FDA acted. Liveyon, LLC, recalled these products on September 28, 2018. You got what amounts to a PRP injection and the proper price for an injection like this would be max a few thousand dollars. These are products derived from either the amniotic sac/fluid or the umbilical cord blood/Wharton’s jelly. If this stuff is injected into a knee, the knee will likely develop septic arthritis (loss of cartilage due to the infection eating away at the joint). Your neck has joints about the size of your finger joints that help to control…, There's been an interesting trend out there for years, but one I have never really…, The most common cause of headache is your spine. YORBA LINDA, Calif., Feb. 27, 2019 /PRNewswire/ -- For many companies in the fledgling stem cell regenerative medicine industry, an FDA recall of the primary product it distributes may be the death knell for the business as other firms step in to fill the void left in the rapidly growing market. Liveyon will resume distribution of the new product line effective Monday, October 8, 2018. However, in the push to convince providers that these dead products have live cells, a few companies have moved away from the safer terminal sterilization and instead ship frozen tissue without sterilization. Liveyon LLC, a marketer and distributor of stem cell products manufactured by Genetech Inc., is recalling products from its ReGen Series after receiving reports of adverse events.. Liveyon was contacted in September 2018 by the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), which oversees human cells and tissue-based products, regarding … (Jan. 2, 2019) The FDA warned Genetech, Inc. and its president Edwin N. Pinos on Dec. 20, 2018 for marketing stem cell therapies without FDA approval. In fact, they rely on a sterile processing technique to reduce the risk of contamination, which as we see in the case of Liveyon failed. Liveyon issued a recall of the implicated products in October. Liveyon marketed and distributed these products under the trade name ReGen Series®. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. Liveyon, a company in Yorba Linda, Calif., sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? These tissues have some stem cell content when alive, but by the time they’re collected, transported, processed, frozen, shipped, and shock thawed by a doctor, it’s all dead. Twelve patients became seriously ill after receiving injections that supposedly contained stem cells from umbilical cord blood, according to the Food and Drug Administration, which issued … Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions. Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Most physicians who buy this stuff and patients who fall for the ruse that this is a “young stem cell product” rather than dead tissue believe that it’s carefully FDA regulated. Join Chris Centeno, M.D., founder of Regenexx, to learn about how Regenexx stem cell and platelet procedures can treat your orthopedic injury. To do this, they have moved to shipping cells that are frozen. Nothing could be further from the truth. 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. • Patients should be informed of the infection risks associated with the ReGen Series® and other non-FDA approved umbilical cord blood-derived stem cell products. One of the things that these companies do to try and sell this stuff is to use simple live/dead stains to report a viability number without doing the more expensive and time-consuming tests required to actually determine if there are live and functional stem cells. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. On October 10, 2018, Liveyon issued a national recall of all ReGen Series stem cell products. The products are distributed under the trade name ReGen Series. The patients in Arizona, Florida and Texas received stem cell products processed by Genetech Inc. and distributed by Liveyon LLC, the report … More Recalls, Market While these frozen products are tested as a batch for communicable diseases in the donor, they aren’t tested sample by sample for contamination in the same way that cell drugs are required to be tested. In addition, unlike a surgical procedure that risks one patient, with these products, many more patients can be placed at risk all over the country. This product contains cells, stem cells and growth factors which may serve as a therapy for various degenerative diseases/disorders.” Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. “CDC tested unopened vials obtained from the Texas and Florida clinics where the initial … The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive. Liveyon immediately discontinued the purchase any product from Genetech and has procured new product from an alternative manufacturer. Your email address will not be published. Liveyon Enters the Picture a few years back, Liveyon entered the picture selling umbilical cord blood and claiming that it had many live stem cells. FDA Recalls Umbilical Cord Product from Liveyon, I have never seen any convincing data that it’s remotely true, Aspirin: High Risk of Hemorrhage Outweighs Minimal Heart Benefits, High-Intensity Interval Exercise vs. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. This success was due in no small part to Liveyon… Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts. ... Liveyon issued a recall. With Genetech's help, Liveyon soon became the preeminent distributor of stem cell medicine, shipping twice as many stem cells as all the other suppliers combined. In response, on September 28, Liveyon issued a voluntary recall and immediately discontinued purchase of the Genetech-processed stem cell products (2 3 On October 4, CDC issued a nationwide call for … On 9 December, the agency issued a safety alert, warning the public about … Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. So, how useful was the recall notice to the public? The suit alleges she was harmed by tainted umbilical cord products sold by Liveyon, a Nevada-based stem cell distributor. Copyright © Regenexx 2021. And epidural steroid injections are problematic due to their long-term negative impact on bone density. Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. By combining stem cells and growth factors, our product may give a longer lasting effect and improve quality of life for those suffering from debilitating disease/disorders, such as arthritis and orthopedic indications. The decision to stop shipment of Genetech products and implement the recall was to ensure the safety of all patients, regardless of whether the adverse reactions were product- related or the result of any procedural misuse of the product. |. It’s a marketer of an “umbilical cord stem cell” product that was recently recalled by the FDA. This is the bright line difference between a voluntary registration and a 351 cell-drug approval. Despite this, the company has been known for very sexy and splashy advertising. In the never-ending push to convince providers that dead tissue is really millions of young stem cells, many of these birth-tissue vendors have left the safety of “terminally sterilized” tissue. Let’s explore this further. The new manufacturer is a US-based, FDA registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the America Association of Blood Banks (AABB). Behind-the-Scenes Look at Events Surrounding FDA Recall of Genetech Products and Plans for Liveyon to Produce its Own Stem Cell Concentrate Derived from Umbilical Cord Blood Liveyon issued a recall of the implicated products in October. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions. Situation: Liveyon, LLC issued a recall … You can inquire what you were injected with, and if this was with Liveyon, then you should see a qualified medical doctor. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. We may also contact you via email, phone, and other electronic means to communicate information about our products and services. By combining stem cells and growth factors, our product may give … To learn more, see my video below: As I hinted above, the FDA has two classifications for cell-based products that come from a donor. Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. CDC is investigating bacterial infections in patients who have received stem cell products from the ReGen Series® (distributed by Liveyon, LLC). The other is a cell drug, which is called a 351 designation, and this would require full FDA approval with clinical trials. Liveyon suspended sales of its stem cell product a week after being warned by the Food and Drug Administration that it was selling an unapproved product … Liveyon … Liveyon will resume distribution of the new product line effective Monday, October 8, 2018. Liveyon recalls all Genetech Products (Jan. 2, 2019) The FDA warned Genetech, Inc. and its president Edwin N. Pinos on Dec. 20, 2018 for marketing stem cell therapies without FDA approval. The FDA … This site disclaims any liability for damages or negative consequences from treatments provided by the physicians listed herein to any person referencing GetRegenerative.com. Endurance Exercise for Cell Health, Other Degenerative Conditions & Overuse Injuries, Other Knee Ligaments / Tendons & Overuse Injuries, Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb), Ulnar collateral ligament wear (common in baseball pitchers). Get fresh updates and insights from Regenexx delivered straight to your inbox. One requires that the cells be dead (no metabolic activity) and is called a 361 tissue registration. All rights reserved. The FDA has recalled a Liveyon product called its Regen Series vials. Yes, if they used an amniotic or umbilical cord product and told you this was stem cells, then you were scammed. Now there’s a new twist in that the FDA has just recalled an umbilical cord product. Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions. Liveyon marketed and distributed these products under the trade name ReGen Series®. In response, on September 28, Liveyon issued a voluntary recall and immediately discontinued purchase of the Genetech-processed stem cell products (2,3). What was interesting was that unlike some of the other … This FDA Liveyon recall exposes the risk that providers and patients take in using these products that claim to have live stem cells. Before sharing sensitive information, make sure you're on a federal government site. Indeed, in addition to the Liveyon warning, FDA sent letters to RichSource Stem Cells and Chara Biologics for offering unapproved stem cell products to patients. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures. Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain. This may come as a surprise…, On a Facebook live yesterday on my "You've Got the Power" show, someone brought up…. Federal regulators are cracking down on clinics offering stem cell injections, warning that the treatments can be unsafe. Mundell HealthDay Reporter FRIDAY, Dec. 21, 2018 (HealthDay News) -- After infections tied to unapproved stem cell treatments sent 12 people to hospital this past year, the U.S. Food and Drug Administration on Thursday issued a stern warning about the products. They can even be used to reduce pain and delay knee replacement for more severe arthritis. Liveyon, according to its website, bills itself as “the exclusive worldwide distributor of a regenerative medicine product that is derived from umbilical cord. I’m sure that alone has convinced quite a few doctors to use the products. I’ve been hearing the name Liveyon pop up more often in the unproven stem cell … The site is secure. No birth-tissue product to date has a 351 cell-drug FDA approval for orthopedic use. This is common in this space. 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.” On October 4, CDC issued a nationwide call for reports of culture-confirmed infections in patients who had received the Liveyon product. With Genetech's help, Liveyon soon became the preeminent distributor of stem cell medicine, shipping twice as many stem cells as all the other suppliers combined. Liveyon has secured a manufacturer which has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility. Liveyon immediately discontinued the purchase any product from Genetech and has procured new product from an alternative manufacturer. Atlas Medical Center began selling umbilical cord stem cells purchased from Liveyon and claims stem cells can be used to help a plethora of health issues, from … Recent Recalled Product Photos on FDA's Flickr Photostream. This means that they sterilize the cells by killing every living thing before shipping it to providers. Hip injuries and degenerative conditions become more common with age. Screenshot from Liveyon Luma website suggesting stem cells and exosomes are connected in this product. Most of these patients developed symptoms such as pain, swelling, or chills within a few days of receiving the stem cell products. It is a member of the Be The Match Program and has passed all FDA inspections. In 2018, 12 patients were hospitalized for infections caused by contaminated ReGen Series stem cell products manufactured by Genetec and distributed by Liveyon. YORBA LINDA, Calif., Feb. 27, 2019 /PRNewswire/ -- For many companies in the fledgling stem cell regenerative medicine industry, an FDA recall of … The U.S. Food and Drug Administration (FDA) has over the past week taken multiple actions against makers of stem-cell products. To no avail! Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc. For example, if autologous cells become contaminated, they impact one patient, identical to the risk of a surgery causing an infection. Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. In that way, the doctor can rest assured that he or she won’t get a contaminated sample. They do not constitute an endorsement of any medical provider nor guarantee the efficacy of the treatments provided. Let me explain. On 5 December, the agency warned California-based Liveyon that its unapproved stem cell … FRIDAY, Dec. 21, 2018 (HealthDay News) -- After infections tied to unapproved stem cell treatments sent 12 people to hospital this past year, the U.S. Food and Drug Administration on Thursday issued a … You probably remember Liveyon. Working closely with the FDA, Liveyon has executed a strategic recall action plan and has immediately begun the voluntary recall process. In fact, I’ve blogged before on why the data that Liveyon provides to physicians as “proof” that its product has live mesenchymal stem cells, from a scientific standpoint, isn’t worth the paper it’s written on. The U.S. Food and Drug Administration (FDA) has over the past week taken multiple actions against makers of stem-cell products. The decision to stop shipment of Genetech products and implement the recall was to ensure the safety of all patients, regardless of whether the adverse reactions were product- related or the result of any procedural misuse of the product. In fact, as you’ve learned above, all it takes is filling out a free 45-minute form online to register your product. This FDA Liveyon recall exposes the risk that providers and patients take in using these products that claim to have live stem cells. stem cell products not distributed by Liveyon, LLC. The suit alleges she was harmed by tainted umbilical cord products sold by Liveyon, a Nevada-based stem cell distributor. Behind-the-Scenes Look at Events Surrounding FDA Recall of Genetech Products and Plans for Liveyon to Produce its Own Stem Cell Concentrate Derived from Umbilical Cord Blood The recall came on the heels of an FDA notification on September 28 th indicating “possible adverse reactions due to the use of ReGen Series product.” Liveyon … The scope of the disaster is limited. Most of these patients developed symptoms … The recall was due to adverse events that may have included … HOUSTON (PRWEB) January 08, 2019 -- (Houston) Law firm Hampton & King have filed a petition against San Diego stem cell manufacturer Genetech, Nevada distributor Liveyon, clinic Texas Regional Health & Wellness, and two doctors, Sammy Tao DC and Omar Vidal MD. This is an interesting article. On September 28, 2018, Liveyon, LLC (Liveyon), a distributor of stem cell products manufactured by Genetech, Inc. (Genetech), a laboratory that was located in San Diego, California, voluntarily recalled … In ads and on its website , Liveyon says its product is "as miraculous as the birth of a child itself" and "stimulates regenerative healing". We do not sell, or share your information to third party vendors. Liveyon’s ReGen series of products were recalled last year after … Get Regenerative does not diagnose or treat medical conditions via this website or via telephone.