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FDA Compliant / Evidence Based Regenerative Medicine

FDA Compliant Regenerative Medicine

Stem cells, like other medical products that are intended to treat, cure or prevent disease, require U.S. Food and Drug Administration (FDA) approval before they can be marketed. At this time, the FDA has not approved any stem cell-based products for use, other than cord blood-derived blood forming stem cells for certain blood diseases. Furthermore, the devices that allow physicians to minimally manipulate blood, bone marrow and adipose tissue for the treatment of orthopedic conditions also require FDA approval.

While the FDA does not regulate the practice medicine, it has issued compliance guidelines regarding the use of human cells, tissues and cellular or tissue-based products. At San Diego Orthobiologics Medical Group, we recognize the FDA’s important role in assuring patient safety. All of our treatment protocols are compliant with the published FDA guidances.

For more information, visit: Guidances

Evidence Based Regenerative Medicine

At this time, Regenerative Medicine is not taught in medical school or residency. The American Academy and Board of Regenerative Medicine was recently formed in 2016. The doctors of San Diego Orthobiologics Medical Group are avid students in their respective fields. They teach at the national level and publish book chapters, research articles and serve as editors for peer reviewed journals. They have gained their experience and knowledge by attending dozens of medical conferences, visiting other medical practices around the world and by reading hundreds of published research articles and textbooks.

Some people say that there is no “proof” that Regenerative Medicine is effective. And while it is true that we are in the earliest years of the development of this field, the evidence is mounting at an accelerated rate. There is a mountain of basic science research that examines the complex biological mechanisms of cellular health and tissue regeneration. The behavior of platelets, stem cells, immune system cells and natural substances in the blood has been extensively studied. The clinical application of Regenerative Medicine has demonstrated remarkable early results and a reassuringly high safety profile. And widespread anecdotal evidence from patient testimonials are convincing and surely not the result of a placebo response.

We use the peer-reviewed published medical literature when available, our understanding of cellular biology and years of clinical experience to guide us in uncharted territory with our patients. We remember our Hippocratic oath to “do no harm” and assess the risks and benefits on a case by case basis allowing the patient to use the evidence to guide their decisions.

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