Cellular Medicine Association - April 2018

CMA CELLULAR EDICINEASSOCIATION

Vol. III APR 2018

A Newsletter of the Cellular Medicine Association

Cell Doctor News Improve Healing and Profits With Cellular Medicine

CellularMedicineAssociation.org

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Why when someone says, “The O-Shot® is not FDA approved,” what they are really saying is “I do not know what the FDA does.”

WHICH IS NO MORE REGULATED THAN THEIR HAIR OR URINE. PRP obtained from a 510(k)-cleared device is unregulated because it's just blood. Basically, you've isolated the platelets, but you've done very little to them. On the other hand, when it comes to stem cells, the FDA says that any procedure in which human cells are manipulated is subject to clinical oversight. More than “minimally manipulated” IS the exact phrase. If they're more than minimally manipulated, then it must be treated like a drug. Here's the approach of the authors of this article: see references at VampireFacelift. com/ prp-fda . They discuss it with the patient. They review the research. They have a consent form that people sign in which they promise them no guarantee, that their options include not treating the condition at all, and that they encourage the person to talk to their primary care physician, which I always do. I'll even make phone calls to the primary care physician so other physicians are involved in the conversation. Then, in the days following the injection, you follow up with phone calls and records. This is what we will be doing with some of the surveys that'll be sent out so we can collectively pool our data. These authors say, "To date, we've not observed any serious adverse events or unanticipated effects that fall outside the scope of what you would expect from an injection." For a detailed video about the FDA stance on PRP and stem cells — with multiple references

Charles Runels: When it comes to the Vampire Facelift®, the O-Shot®, and the Priapus Shot® and the FDA, you will want to think about exactly what the FDA regulates. Many pathways can be used to bring a drug or a medical device to market. Most of the FDA- approved PRP-preparation kits came through a 510(k), where a device is given clearance because it's equivalent to a previous device, and these devices were approved to prepare platelet-rich plasma for use in bone, for mixing with bone transplants, and they've been shown to help. There are numerous PRP preparation systems on the market with FDA clearance. Nearly all of them are cleared for producing platelet-rich plasma mixed with bone graft materials to enhance the take of that. I am grateful that the FDA does regulate both of the following: (1) the device is safe/sterile and (2) the device actually isolates platelets. A PRP system with clearance indicates a device is safe in that it does not create a preparation that's hazardous or dangerous, which could happen if you used a lab kit that's made to isolate platelets for analysis (not for re-injection back into the body), because the level of sterilization is different. So, the FDA-approved devices that we use prepare the plasma in a way that it is safe for the patient. The second thing the FDA examines concerning the PRP kits is the capability to actually isolate the platelets from the whole blood. Though the two above-listed attributes should be required by the FDA — AND THIS IS KEY — when it comes to our procedures, the FDA does not regulate the practice of medicine — the FDA does not regulate procedures.

The FDA does not regulate cholecystectomies, hysterectomies, O-Shot®, or Vampire

Facelift® procedures. Never, ever, AMEN.

Even when it comes to drugs, clinicians are free to use a product off-label. We do this VERY FREQUENTLY because we know that, if there is research to support the idea, then we do the research and the FDA lets the doctor decide. Over half the drugs that are prescribed by oncologists are off-label. In some studies, 20–30 percent of the prescriptions written by a family practitioner are off-label. But when you use PRP, you’re NOT even using it off-label — THERE IS NO LABEL — IT’S THE PERSON’S OWN BLOOD,

written by the FDA — go to VampireFacelift.com/prp-fda .

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