Can clinics in the U.S. still offer stem cell therapies? Yes, but only under strict FDA regulations. Clinics offering therapies involving significantly processed stem cells, such as adipose-derived SVF or WJ-derived stem cells, must comply with FDA guidelines. This includes conducting clinical trials, proving safety and efficacy, and adhering to Good Manufacturing Practices (GMP). Non-compliant clinics risk legal action, fines, or injunctions. For many clinics, meeting these regulatory demands is financially and logistically challenging, limiting the availability of advanced stem cell therapies in the U.S. What does this mean for patients seeking advanced stem cell therapies? Patients in the U.S. may face limited access to advanced stem cell therapies due to regulatory restrictions. Treatments involving expanded or processed stem cells, such as those offered at LMI, are not available outside of clinical trials in the U.S. This ruling emphasizes the importance of seeking treatment from reputable clinics that comply with international standards and ensure patient safety, such as LMI, which offers cutting-edge therapies that go beyond what is currently allowed in the U.S.
Exosomes FAQ's
What Are Exosomes and How Do They Work in Regenerative Medicine? Exosomes are small particles released by stem cells that carry proteins, lipids, and genetic material to other cells, acting as messengers. They promote healing by reducing inflammation, stimulating cell repair, and supporting regeneration. Exosomes are an important part of regenerative medicine as they enhance the body's natural healing processes.
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