The FDA has spoken and gone already is the circus of Amniotic Fluid IV, Cord Blood, and Wharton’s Jelly. Below is an example of the headline in a letter from the FDA sent December 20, 2018
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
Genetech, Inc. warned about umbilical cord blood-derived cellular products distributed by Liveyon, LLC. FDA is also sending letters to other firms and providers offering stem cell treatments notifying them of agency’s regenerative medicine policy framework.
Today’s Top Story
FDA Warns Clinics After 12 People Are Hospitalized Following Unapproved Stem Cell Injections
According to The New York Times, 12 people were hospitalized after receiving unapproved stem cell injections marketed by Genetech, Inc. The products were derived from umbilical cord blood and were injected into knees, shoulders, and spines to treat injuries and conditions like arthritis. These patients contracted infections (from E. coliand fecal bacteria) in the bloodstream or joints, and one patient was hospitalized for 58 days. The U.S. Food and Drug Administration (FDA) sent a warning to Genetech for marketing these products without FDA approval and for significant deviations from current good tissue practice and current good manufacturing practice requirements. The agency also said it recently warned 20 clinics that offer unapproved stem cell treatments, although the names of the clinics have not been released.
“Federal Trade Commission takes action Stem Cell Clinics making deceptive claims about Amniotic Fluid Products.”
How much longer will we see those seminars ads in our newspapers? At last look, they are still at it; but it is time for the hoax to be closed down.
In-office Needle Arthroscopy
Knee pain is one of the most common reasons for medical office visits in the United States. Evaluation of the patient begins with a focused history and physical exam. If radiographs are nonrevealing, advanced imaging, such as MRI, often is required to arrive at a diagnosis and develop a treatment plan. Although MRI remains a standard of care in the workup of suspected intra-articular knee injuries, it does have limitations.
A greater number of these injuries may be missed in patients who have previously undergone a knee operation, have metallic implants near the knee joint, or have injuries to multiple structures. In addition, MRI remains limited in its ability to definitively diagnose or quantify cartilage injuries Given these and other limitations, diagnostic arthroscopy remains the gold standard in the diagnosis of intra-articular knee injuries.
Evidence Based Cellular Orthopedics
In November and December, I was the senior author of two major scientific cellular orthopedic outcomes publications that are already impacting the way regenerative medicine is being practiced. Two major regenerative medicine national meetings have added our outcomes findings to their respective agendas.
Scheduled the first half of 2019:
Completion in March of the prospective study on OA treatment with combined intraarticular and intraosseous (subchondroplasty)intervention at the knee.
Creation of a scientific manuscript concerning our 1 to 2-year outcomes in 65 patients who received intraarticular intervention with combined Bone Marrow Concentrate and Growth Factor Concentrate
Review of our Hip outcomes data in patients receiving Bone Marrow Concentrate for Osteoarthritis
Develop the outcomes evaluation abstract in grades 2 and 3 Osteoarthritis of the knee; 117 patients at 1 to 2-years treated with Platelet Rich Plasma derived proteins (Growth Factors).
If you want to learn more about our evidence-based care call (312) 475-1893
You may visit my web site www.sheinkopmd.com