The U.S. Food and Drug Administration (FDA) has warned Genetech, Inc. of San Diego, CA for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients. Genetech processed umbilical cord blood from into unapproved human cellular products, which was distributed by Liveyon, LLC.
Genetech, and other similar companies, take donated human umbilical cord blood from woman giving birth and they process the blood, allegedly to extract the stem cells and growth factors. The final product is then packaged and marketed to physicians and clinics. In the case of Genetech, the product sold by Liveyon is marketed as containing viable stem cells. However, independent testing has verified that Liveyon contains NO live viable stem cells. In fact, there is NO commercially available product that contains ANY live viable stem cells. Period. The FDA is also sending letters to other firms and providers offering stem cell treatments notifying them of agency’s regenerative medicine policy framework.
Patients need to be educated on this last point because an increasing number of questionable "stem cell" clinics are marketing "stem cell" treatments involving the use of amnion, placenta, or cord blood-derived products. Such claims are not only completely fraudulent but also a violation of FDA regulations.
While orthobiologic products derived from human placenta, amniotic fluid/membrane, or cord blood CAN have therapeutic benefit (and here at the New England Stem Cell Institute we use some of these products very judiciously), they are NOT "stem cell" treatments. Currently the only FDA cleared stem cell treatments are those that use the patient's OWN stem cells, and only when processed according to approved FDA guidelines.
You can be fully assured that EVERYTHING we do here at the New England Stem Cell Institute complies fully with FDA guidelines, and we will NEVER do anything that puts our patients' health, and our reputation, at risk.
Full story: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628918.htm
A new study published in the journal Cartilage showed that PRP (platelet-rich plasma) injections are significantly more effective than cortisone injections for treating symptomatic arthritis of the thumb.
33 patients were randomized to receive either 2 cortisone injections or 2 PRP injections, spaced 2 weeks apart. They were evaluated at 3 and 12 months after the 2nd injection. After 12 months' follow-up, the PRP treatment group showed significantly better results in comparison with the corticosteroids.
This study is important because 1) Many people suffer from arthritis of the thumbs; 2) It confirms via research what we've been seeing clinically-- that PRP does work, and 3) it provides a viable alternative to steroids, which have been shown to cause further joint deterioration when given repeatedly. Until the advent of PRP there had been very few good options for treating arthritis.
However not all PRP is the same! Rather than relying on one-size-fits all commercial PRP kits, we make our own PRP to insure the highest quality and most effective PRP, and we tailor it for the individual patient. Also, not all injections are given the same way, even when done under ultrasound. We've been doing PRP longer than anyone in New England, and longer than most in the country. Few have our level of skill and experience. And, we're nationally recognized experts in musculoskeletal ultrasound. Let us help you with your arthritis or chronic pain condition. Call today!
CLICK HERE for more information about PRP.
Nov. 25, 2018
"Intra-articular injections of platelet-rich plasma [PRP] are associated with better outcomes than hyaluronic acid in knee osteoarthritis." So conclude the authors of a new study published in the Scandinavian Journal of Surgery.
The study looked at 190 patients with knee osteoarthritis (OA). (OA is the common "wear and tear" type.) 94 patients received PRP injections while 84 received hyaluronic acid injections. Each patient received 3 injections and were evaluated before injection, at 15 days, 6 months, 12 months, and at last follow-up. Hyaluronic acid-treated patients experienced a higher arthroscopic surgery rate (36.0% vs 5.3%), lower range of motion, and worse scores on standardized tests than the PRP-treated patients.
Hyaluronic acid injections are also common referred to as "HA" injections, "gel" injections, and "viscosupplementation" injections. Common commercial products include Synvisc®, Hyalgan®, Monovisc®, Gel-One®, and Euflexxa®, to name just a few. These products are commonly used to treat knee OA.
To learn more about PRP and how we can help you with your arthritis pain, click here!
59 Sycamore St, Suite 301
Glastonbury CT 06033