In 2018, the CDC investigated the reports of several patients in multiple states who developed bacterial infections after receiving the ReGen Series stem cell products distributed by Liveyon, LLC. The CDC determined the infections were probably due to contaminated stem cell products after they found bacteria in a number of unopened vials obtained from multiple clinics. The ReGen Series products …
Adverse Events Tied to Exosome Therapy in Nebraska
An article published in December 2019 by MedPage Today reported that several individuals developed severe infections after receiving a placental derived exosome product in Nebraska. The Department of Health and Human Services (DHHS) stated that less than five patients became seriously ill and some developed sepsis. Specific details including the name of the product, source of donor placental tissue, and …
A Review of Two Cases of Patients Harmed by Intra-articular Stem Cell Injections
In December 2019, Taliaferro et al published an article entitled “Cash-Based Stem-Cell Clinics: The Modern Day Snake Oil Salesman? A Report of Two Cases of Patients Harmed by Intra-articular Stem Cell Injections”. The article was published in the Journal of Bone & Journal of Surgery Case Connector, a journal that provides information to orthopedic surgeons for the discovery and reporting …
Liveyon Labs Inc. Receives Warning Letter From FDA
In December 2019, 7 months after their initial inspection, the FDA sent a warning letter to Liveyon Labs, a major producer of umbilical cord derived tissue and other products in California, to take corrective action and become compliant with specific regulatory criteria. The FDA determined that Liveyon Lab’s human umbilical cord blood products PURE and PURE PRO qualify as drugs, …
Professional Athletes and Stem Cell Therapy
Despite claims in the media from bloggers, medical school professors and doctors alike that stem cell therapy doesn’t work and is not proven, this therapy is becoming recognized as a legitimate treatment option for a variety of conditions, especially orthopedic conditions. This is highly attractive to anyone with a musculoskeletal injury that hasn’t been resolved with conventional medicine and is …
Recent Legal Battles and FDA Warning to Stem Cell Companies
In 2008 Regenxxx (Des Moines, IA) was forced to stop using cultured and expanded cells in the US after a protracted legal battle with the FDA for violations of manufacturing a drug product without approval. In 2018, the DOJ/FDA initiated a court case against US Stem Cell Clinic (Weston, FL) and US Stem Cell Inc. (Sunrise, FL), seeking permanent injunction …
