Disclaimer

The FDA plays a vital role in overseeing stem cell therapy, just as it does with other medical treatments. In 2019, the agency issued a strong warning about the risks of unproven stem cell therapies, cautioning against misleading claims that market them as miracle cures. Currently, the FDA has only approved cord blood-derived stem cells for treating specific blood-related conditions.

Most stem cell therapies remain in the research phase. To support the responsible advancement of regenerative medicine, the FDA released guidance in 2017 outlining its regulatory approach. This includes clear compliance standards for human cells, tissues, and cellular-based products to ensure patient safety.

At Engelen Sports & Orthobiologics, we fully adhere to these FDA guidelines, prioritizing minimal manipulation and homologous use in our treatment protocols. The commercial systems we use for processing autologous cellular products—such as platelet-rich plasma (PRP), bone marrow concentrate, and MFAT—are all FDA-cleared, maintaining the highest standards of purity and effectiveness. We do not culture cells, nor do we offer amniotic or birth tissue injections, ensuring that our practices align with regulatory requirements and patient safety standards.