FDA Compliance

At Ortho Therapeutics and Wellness we follow the research and the rules to ensure FDA Compliance and patient safety. Understanding Stem Cell Therapy Stem cell therapy has been around for decades, but its use has grown a lot in recent years. This treatment is designed to help repair or replace damaged tissue and cells. Many experts hope that stem cell therapy will eventually be used to treat various conditions. Like all medical treatments, stem cell therapy is regulated by the U.S. Food and Drug Administration (FDA). In 2019, the FDA cautioned patients to be careful of clinics promoting unproven stem cell treatments as “miracle cures.” The FDA has only approved a few stem cell-based therapies—specifically, specific blood-forming stem cells from cord blood used for blood disorders. Most stem cell therapies are still being studied. That’s why, in 2017, the FDA announced it would allow some flexibility to help speed up the development of promising new treatments. We fully support the FDA’s role in keeping patients safe. We follow all the guidelines they’ve established for how human cells and tissues should be used in treatment. Our protocols are based on “minimal manipulation” and “homologous use,” which means we use your cells in ways that are safe, natural, and consistent with their original function. The systems we use to process platelet-rich plasma (PRP) and bone marrow concentrate are all FDA-cleared to ensure safety, quality, and effectiveness. Even though the field of orthobiologics is still developing, research is moving quickly. Ortho Therapeutics and Wellness stays current through medical literature and published research. Our goal is to offer evidence-based, minimally invasive treatments for minor orthopedic conditions. We do not use Stem Cells umbilical cord blood, Amniotic fluid injections or Exosomes. These all fall outside of FDA statutes and regulations. We only use Autologous cellular therapy which involves using a patient's own cells to treat a condition. Click here for more information regarding the FDA's Regulations pertaining to Regenerative Medicine Products.