The Karlfeldt Center · Meridian, Idaho
Amniotic-derived products marketed as stem-cell therapies are not FDA-approved for most orthopedic conditions. Before considering one, ask exactly what product is used, its FDA status, evidence, risks and alternatives. Read FDA patient information.
Some clinics offer amniotic-derived products for joint and tendon complaints. Products and regulatory status differ, and the word “stem cell” does not tell you whether a product contains viable cells or is approved for your condition. We encourage patients to review the exact product, evidence, risks and alternatives with a qualified clinician.
The clinic may discuss amniotic-derived products for musculoskeletal concerns. These products are not established treatments for osteoarthritis or tendon injuries. The FDA states that many regenerative products marketed for orthopedic conditions are not FDA-approved for those uses. Ask which product is proposed and what evidence supports that specific use.
Harnessing the Power of Regeneration
Amniotic tissue products vary in processing and composition. Marketing descriptions may use terms such as growth factors or stem cells, but those terms do not establish that a product contains living stem cells or has demonstrated clinical benefit for a particular condition. Ask the provider for the product label, source, processing method and regulatory status.
Claims such as cartilage growth, tissue regeneration, steroid-free healing or minimal rejection should not be assumed. Benefits and risks depend on the specific product and use, and strong evidence for most orthopedic applications is lacking. Ask what outcomes have been studied in people and whether a standard treatment or clinical trial is a better option.
FDA information for patients describes potential risks from unapproved regenerative products, including infection and unwanted tissue growth. A consultation should cover product identity, sterility, risks, realistic expectations, alternatives and how the decision fits with your current care. Read FDA patient information.
Joint or tendon pain alone does not establish that an amniotic-derived product is appropriate. A clinician can review your diagnosis, the exact product being considered, evidence, risks and established alternatives.
Contact us to discuss the product and your questions. We can explain what the clinic offers; decisions about regenerative products should include an independent review of FDA status, evidence, risks and established treatment options.
Fax: 208-345-3225
Monday: 9 AM - 4 PM Tuesday: 9AM - 5PM Wednesday: 9AM - 6PM Thursday: 9AM - 5PM Friday: 9AM - 4PM