Auragens Lobby in Panama City, Panama
At Auragens, we prioritize your health and well-being by keeping you informed about the latest developments in stem cell treatments and regulatory guidelines. Considering recent warnings from the U.S. Food and Drug Administration (FDA), we want to provide you with key information to help you make informed decisions regarding regenerative medicine products, including stem cell therapies. Below are some critical points to keep in mind when considering such treatments, especially in the United States.
Understanding Stem Cell Treatments in the U.S.
FDA Regulation
The FDA oversees the regulation of all regenerative medicine products within the U.S., including stem cells and exosome therapies. These treatments must undergo stringent review processes before being approved for use.
Limited Approvals
Currently, the only FDA-approved stem cell treatments in the U.S. involve blood-forming stem cells derived from umbilical cord blood. These are approved for specific blood-related disorders.
No Approved Exosome Products
As of now, there are no exosome products that have received FDA approval in the U.S.
What to Watch Out For
Misleading Information
There is a growing amount of misinformation online regarding stem cell and exosome treatments. Be cautious of false claims from U.S. based clinics regarding their ability to treat a wide range of conditions as these therapies have little to no oversight in the U.S.
Unapproved Uses of Stem Cells
The FDA has not approved stem cell or exosome products for the treatment of the following:
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COVID-19 or complications arising from it
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Orthopedic conditions such as osteoarthritis or tendonitis
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Neurological disorders, including multiple sclerosis, ALS, and Alzheimer’s disease
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Cardiovascular or pulmonary diseases
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Autism, macular degeneration, chronic pain, or fatigue
Potential Risks
Using unapproved stem cell treatments can expose you to significant health risks. These treatments have not undergone the necessary safety and efficacy testing.
Auragens’ Commitment to Safety and Compliance
At Auragens, we operate under the regulatory guidelines of the Panama Health Authority, which differs from the FDA’s jurisdiction in the U.S. Here’s what you should know about our practices:
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Compliance: While we are compliant with U.S. law, and follow all FDA, AABB, cGMP, and ISO protocols, our products and treatments are not available for use within the United States at this time.
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Distinct Offerings: Our stem cell therapies are distinct from what is currently available in the U.S. market and are tailored to ensure safety and efficacy under Panamanian regulations with regular inspections and quality control assurance and oversight.
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Future Goals: We are committed to making our treatments available in the U.S. when FDA regulations allow, and our goal is to ensure safe and effective stem cell therapies. Our methodology and safety protocols are kept at the highest level to meet the regulations in the U.S. once regulations allow for our treatments.
What You Can Do
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Consult Healthcare Providers: If you are seeking treatment within the U.S., consult a licensed healthcare professional about FDA-approved options for your condition.
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Exercise Caution: Be wary of clinics in the U.S. offering unapproved stem cell treatments, particularly for conditions not covered by FDA approval as they are operating on the fringes and without a check and balance to protect patient safety.
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Understand the Landscape: If you are considering treatment with Auragens, please remember that we operate under Panamanian law and not the FDA and we exceed all requirements in the international community. However, our products are not yet available in the U.S. nor is any similar treatment legally being done in the U.S.
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Report Adverse Events: If you experience any adverse effects from unapproved treatments received in the U.S., you should report them to the FDA’s MedWatch Adverse Event Reporting program.
Learn More
If you have any questions about the regulation of regenerative medicine products in the U.S., or the FDA’s approval process, you can contact the FDA directly:
Phone: 800-835-4709
Email: [email protected]
For more information about Auragens’ treatments and our operations in Panama, feel free to reach out to our team.
Auragens: Advancing Stem Cell Therapies for the Future
At Auragens, we are dedicated to your health and safety. As we continue to push the boundaries of stem cell therapy, we encourage you to make well-informed decisions based on science and regulatory standards. Please don’t hesitate to reach out to us with any questions or concerns.
Stay safe, become informed, and thank you to all for the continuing trust in Auragens.
