If you’re considering Regenerative Medicine, Regenerative Cellular Therapies, Stem Cell Therapy, or any other form of biological treatment, please read this article! As these promising treatments rise in popularity, some less-than-legitimate clinics may try to take advantage of a patient’s pain, fear, and lack of knowledge about cellular therapies. By asking these ten questions before you consent to Regenerative Cellular Therapies, cellular, biological, or “stem cell therapy” you can protect yourself or someone you love!

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Dr. Kelley Mulhern

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Regenerative Medicine

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  1. Who determines the treatment process? In some clinics, the treatment decisions are made by one or two providers who may or may not be qualified to provide the best recommendations.  Look for a clinic who has a Medical Advisory Board with Board-Certified Physicians who develop written protocols to treat conditions.  Not only does this ensure Best Practices are being followed, but they can also be called upon to provide advisement on complicated cases.
  1. Are the providers following established, documented treatment protocols? A surgeon would not perform a surgery without written protocols….  It should be a PROCESS, not a one-time injection with no follow-up.  The best clinics also provide advice and/or treatment options designed to improve your nutrition, reduce inflammation, and rehabilitate damaged tissues.
  1. From where is the tissue harvested or sourced?
    • Some clinics source the cells from your own body, by removing fat or bone marrow. These procedures take more time, have more risk of infection or complication, and don’t typically yield an effective number of high-performing cells.  In fact, the FDA recently won a permanent injunction against a Florida Stem Cell clinic who was providing fat-derived stem cell products while not using Best Practices.  Bone marrow harvesting can be more painful and complicated, but may be the only option for those severely immunocompromised.  Therefore, in Regenerative Cellular Therapies, it’s important to note that cells taken from your own body are the same age as you are.  As we age our bodies – and our cells – become less active, less vibrant, and less capable of healing.
    • Many people still think that stem cells are still obtained from aborted fetal tissue. This practice ceased in the 1980s as the research showed these cells were tumorigenic, meaning they caused tumors to form.  However, if we really think about it, the “job” of embryological stem cells is to form a baby.  No matter where we put those cells, they tried to form a baby!
    • Studies have shown that the best source of stem cells and other regenerative cellular products are the birth tissues of rigorously screened, healthy, scheduled caesarean deliveries.
  2. How long has the source company been involved in regenerative cellular therapies? Hundreds of “stem cell clinics” have popped up almost overnight.  Many times they use inferior products and charge a premium price.  Do your research and make sure the tissue company has been in business for a decent length of time.  Better yet, are they registered with the FDA as a multi-state tissue bank?  This means they not only source stem cells, but they may also source organs for transplantation as well as other products.
  1. Is the tissue source company credentialed? Some things to look for include:
    • FDA-Regulated. This means they have completed the necessary forms with the FDA to be held accountable to FDA regulations.  Sounds simple, but many of the “shady” clinics don’t do this because they don’t want to be on the FDA’s radar.
    • Recognized by the American Association of Tissue Banks (AATB). Again, this shows the company is not a new, stem-cell-only, company.
    • CLIA-certified: This stands for Clinical Laboratory Improvement Amendment.  It requires that a lab obtain state credentialing and Centers for Medicare & Medicaid Services certification before being allowed to accept human samples for diagnostic testing.
    • cGMP: This means that the lab follows Current Good Manufacturing Practices as established by the FDA. These standards are developed to assure strength, quality, and purity of a substance being used to treat humans.  It involves strong processes and procedures to prevent contamination, failures, and errors.

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    1. Have you felt pressured to make a decision? The decision to proceed with Regenerative Cellular Therapies is an important, and exciting, one! However, you should not feel pressured to make this decision. Legitimate clinics will take the time to listen to you, to discuss all of your options, provide you with the information you need to evaluate your choices, and give you time to make your decision without high-pressure manipulation or sales tactics.
    1. Are you being promised miraculous results? There is no “magic cell” that can fix all of our physical problems, at least not yet anyway. But there are ways to help the body perform normal processes better, and one of those processes is healing. Healthcare professionals can support that process through education, medication, nutrition, and lifestyle change, and yes, even with certain Regenerative Medicine therapies.
    1. Are you being promised FAST results? Regenerative Cellular Therapy is a PROCESS that takes several months to reach optimal results. All healing in the body takes time, and regenerating tissue would (understandably) take more time.
    1. Are the stem cells or other cellular products HUMAN? This sounds like it should be common sense and basic…but it isn’t. Some shady clinics have lured unsuspecting patients in with cut-rate pricing, only for the patient to learn that they were given animal cells or other products that did not contain stem cells. A colleague of mine had a patient who received stem cell treatment that “didn’t work” and later found out he had been injected with GOAT stem cells.
    2. What types or how many tests are being performed on the donated tissue prior to its use? Legitimate companies will perform testing on the donor mothers – including a medical, social, and family history. They will also perform dozens and dozens of tests on the donated tissue to make sure it is safe for transplantation. Additional tests should be run to ensure the presence and viability of live cells. If your provider does not know if or what testing is done on the tissue, find another provider!

I hope this article has given you some useful information to use in selecting the right clinic to provide your Regenerative Cellular Therapy / “Stem Cell Therapy” / Regenerative Medicine treatment!

Our mission is to help as many people as possible live longer, happier, and healthier lives without pain, drugs, or surgery. We invite you to call our office for a free consultation regarding our cutting-edge Regenerative Medicine treatment options in St. Petersburg. We’ve helped many patients in the Greater St. Petersburg area, and we hope you’ll give us a chance to help you.