Approved Stem Cell Usage In The United States

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Image Credits: Docwire News

“Health is a large word. It embraces not the body only, but the mind and spirit as well;…and not today’s pain or pleasure alone, but the whole being and outlook of a man.”-  James H. West

The medical field is coming full circle. Early in our existence, there was a reliance on natural therapies to heal the body’s ailments. Food was our medicine, and medicine was our food. With the advent of technology, there was an emergence of medical procedures, and synthetic drugs that were able to heal the body. While synthetic drugs have their use, they do often have adverse side effects that can cause the patient to often opt not to take the medicine. As an alternative, researchers delved into a world where they could simply allow the body to heal itself. This revolution, led to the discovery of the healing properties of stem cells. 

What Type of Stem Cell Therapies Are Approved By The FDA? 

The FDA is the regulating authority for the approval of stem cell products in the United States. The types of stem cells used for treatments include stem cells from embryonic sources, as well as adult stem cells derived from bone marrow or fat. Although there are a variety of stem cell clinics globally, the majority of them operate with a disclaimer. They are not actually FDA approved. The FDA has approved products from only one source of stem cell - that from blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. 

The field of stem cell biology is a very complex one. Some of the factors that influence the lack of regulation of the majority of stem cell products is due to the following factors: 

  1. The intricate nature of the genetics of cell development 

  2. The approval phases go through various scales from pilot to full scale trials in humans. Not all results observed in testing lab animals such as mice, scale up to the equivalent in humans. 

  3. The transplanted stem cells may not develop into the desired cells. A deeper understanding of cell biology will be needed to correctly engineer the types of cells needed for the desired therapy. 

  4. The body’s immune response to any injected substances may not be favorable. The body can attack the stem cells in an effort to protect itself as an immune response. It may take a while for the cells to be accepted by the body. 

As the field evolves, and deeper knowledge is gained, there will be an improvement in the available therapies. At best, the existing facilities that are non-FDA approved, are helping to increase the pool of knowledge that exists in the field via clinical trials. 

As a fact, there are stem cell clinics all over the United States, that patients have access to for the treatments of conditions such as cancer, multiple sclerosis, Alzheimer’s and arthritis. Using therapies such as fat derived stem cells, the cells are re-injected into the body to facilitate healing. With minimal evidence, be careful of stem cell clinics that are not FDA approved. There are action steps being taken over the next three years, in order to facilitate their regulation. The primary concern is due to the fact that there are potential adverse side effects which could be detrimental to the patient. With unregulated therapies, there is limited protection if a patient reacts to the treatment.

The benefits of stem cell treatments outweigh their risks, or else there won’t be 570 stem cell clinics in the United States. FDA regulation has been known to take several years, and many doctors are able to access therapies via disruptive technologies that are able to treat patients for conditions that were once considered to be debilitating. Patients are now recovering from conditions such as multiple sclerosis and arthritis thanks to the advent of stem cell therapies. 

Speak to your orthopaedic surgeon, about stem cell therapies. It is an emerging technology that could heal your body with its own natural mechanisms. 

References: 

  1. Rising Tide Biology: https://www.risingtidebio.com/history-stem-cell-therapy-benefits/

  2. Vox Publication: https://www.vox.com/2019/1/9/18173772/stem-cell-therapy-fda

FDA: https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies

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