Why does LMI prioritize multipotent stem cells over pluripotent stem cells? While pluripotent stem cells (hPSCs) derived from embryos, skin, or induced umbilical cord blood have the ability to transform into almost any cell type, this versatility increases the risk of forming tumors or cancerous growths. Multipotent stem cells, which LMI exclusively uses, are safer because they are naturally limited to specific types of tissue differentiation. Our cells deliver powerful regenerative benefits without the ele vated risks associated with pluripotent cells, making them a more secure and effective choice for patient treatments. Why is it unlikely that stem cell therapy will become a standard treatment in the U.S.? A recent court ruling by the Ninth Circuit Court of Appeals classified therapies involving stromal vascular fraction (SVF) - a stem cell product derived from processed fat tissue—as a "drug" under the Federal Food, Drug, and Cosmetic Act (FDCA). This decision requires such treatments to undergo FDA regulation, including approval through Investigational New Drug (IND) applications and clinical trials. Similarly, stem cell products derived from Wharton’s Jelly (WJ) are subject to the same regulations if they undergo significant manipulation or are used for non- homologous purposes. These strict requirements make it difficult for many stem cell therapies to be widely adopted as standard treatments in the U.S. What is the FDA “minimally manipulated” standard, and how does it affect stem cell therapies? The FDA requires that stem cell products be "minimally manipulated" to avoid classification as drugs. This means that the cells must not undergo significant processing or alteration beyond what is necessary to prepare them for their intended purpose. Many therapeutic applications, including those that involve isolating or expanding cells, fall outside this definition, subjecting them to FDA regulation. As a result, treatments often contain low cell counts and are less likely to provide meaningful therapeutic benefits under this standard. 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 sa fety 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 financiall y 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
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