The Washington Times
By Kristin Comella -
Wednesday, June 26, 2019
ANALYSIS/OPINION:
https://m.washingtontimes.com/news/2019/jun/26/how-the-fda-attempts-to-force-itself-on-the-crucia/
For more than 20 years, I have worked in the field of cellular biology and I believe the healing power of our body’s cells will someday become a standard of care. I never expected to see a time when our own stem cells would be subject to government oversight. We came one step closer last week, when a federal court ruled that an individual’s own stem cells are a drug and granted the Food and Drug Administration (FDA) the ability to regulate them as such.
The FDA’s argument in this case was the opposite of guidance the agency has issued in years prior. In fact, in the late ‘90s, the agency “declined to assert any regulatory control over cells or tissues that are removed from a patient and transplanted back into that patient during a single surgical procedure.” The FDA found that the risks would generally be no different than those typically associated with surgery and should be overseen by state medical boards.
Now, more than 20 years later, the FDA is attempting to force itself upon medical practitioners around the country in the regulation and oversight of stem cell treatments by attacking one company at a time. U.S. Stem Cell Clinic is one of the first targets, and we won’t be the last.
I committed myself to this field of study because I care about science and I care about people. And, I have always known there was an alternative solution to health and wellness other than synthetic chemicals. From the moment I entered a cell engineering lab at the Ohio State University, to countless hours of stem cell research at Tulane University, to a life-altering legal battle with the federal government, I have given everything I have to help people heal through the power of their own cells.
In 2001, I joined forces with a group of scientists at Osiris Therapeutics to help progress this incredible field of therapy. Since then, I have studied and tested, and studied and tested — learning the safest, most effective way to harness this method of using the body to heal itself.
In 2006, our network of medical practitioners began using fat tissue for stem cell treatments to help people who wanted better options than opioids, narcotics and invasive procedures to overcome disease and injury. We isolated stem cells from fat tissue to collect stromal vascular fraction (SVF). This out-patient procedure can collect 500 times more stem cells from fat than other procedures, with a much lower inflammatory response since there are fewer white blood cells. By removing a patient’s own cells and injecting them where they are needed, the cells can ignite the body’s healing response.
Having access to these cells is one of the most remarkable advancements in recent modern medicine. Using the protocols developed at U.S. Stem Cell, more than 12,000 patients have been treated by medical practitioners worldwide. While no medical procedure is without risk, dozens of peer reviewed papers have demonstrated safety and efficacy. Patients are getting better; they’re getting out of wheelchairs, off pharmaceutical medications and breathing on their own.
I believe in America, I believe in this therapy and I believe in our rights to use our own body to heal. I was not given the opportunity to have a trial and testify in court, but instead the judge ruled based on written summaries prepared by the lawyers. Furthermore, the media, lawyers and others chose to focus on a handful of adverse incidents, ignoring the thousands of positive outcomes that have been documented in the last 20 years around the world.
Recategorizing our own stem cells isolated during a surgical procedure now as “a drug” is exactly what will prevent Americans from having access to this treatment. There isn’t any surgery that is subject to FDA approval, and this fat-derived stem cell procedure shouldn’t be the first one.
There are people who have been healed because of what we do. And, I will tell you that the doctors I have worked with have only the patient’s best interests in mind. They are not “out to get a patient” or “take advantage” of a patient. I’m not that person. We aren’t those people. The narrative that is pushed about “bad actors” is simply not true.
We must respect the judge’s opinion, and we’re no longer performing this life-changing procedure. However, the FDA has never, and should never, control our own cells in our own bodies. Now is the time for the community of patients, scientists and practitioners who care about our rights and the healing power of our cells to rise up. They’re our cells, it should be our choice.
• Kristin Comella is the chief science officer of U.S. Stem Cell Clinic.
Copyright © 2019 The Washington Times, LLC.
By Kristin Comella -
Wednesday, June 26, 2019
ANALYSIS/OPINION:
https://m.washingtontimes.com/news/2019/jun/26/how-the-fda-attempts-to-force-itself-on-the-crucia/
For more than 20 years, I have worked in the field of cellular biology and I believe the healing power of our body’s cells will someday become a standard of care. I never expected to see a time when our own stem cells would be subject to government oversight. We came one step closer last week, when a federal court ruled that an individual’s own stem cells are a drug and granted the Food and Drug Administration (FDA) the ability to regulate them as such.
The FDA’s argument in this case was the opposite of guidance the agency has issued in years prior. In fact, in the late ‘90s, the agency “declined to assert any regulatory control over cells or tissues that are removed from a patient and transplanted back into that patient during a single surgical procedure.” The FDA found that the risks would generally be no different than those typically associated with surgery and should be overseen by state medical boards.
Now, more than 20 years later, the FDA is attempting to force itself upon medical practitioners around the country in the regulation and oversight of stem cell treatments by attacking one company at a time. U.S. Stem Cell Clinic is one of the first targets, and we won’t be the last.
I committed myself to this field of study because I care about science and I care about people. And, I have always known there was an alternative solution to health and wellness other than synthetic chemicals. From the moment I entered a cell engineering lab at the Ohio State University, to countless hours of stem cell research at Tulane University, to a life-altering legal battle with the federal government, I have given everything I have to help people heal through the power of their own cells.
In 2001, I joined forces with a group of scientists at Osiris Therapeutics to help progress this incredible field of therapy. Since then, I have studied and tested, and studied and tested — learning the safest, most effective way to harness this method of using the body to heal itself.
In 2006, our network of medical practitioners began using fat tissue for stem cell treatments to help people who wanted better options than opioids, narcotics and invasive procedures to overcome disease and injury. We isolated stem cells from fat tissue to collect stromal vascular fraction (SVF). This out-patient procedure can collect 500 times more stem cells from fat than other procedures, with a much lower inflammatory response since there are fewer white blood cells. By removing a patient’s own cells and injecting them where they are needed, the cells can ignite the body’s healing response.
Having access to these cells is one of the most remarkable advancements in recent modern medicine. Using the protocols developed at U.S. Stem Cell, more than 12,000 patients have been treated by medical practitioners worldwide. While no medical procedure is without risk, dozens of peer reviewed papers have demonstrated safety and efficacy. Patients are getting better; they’re getting out of wheelchairs, off pharmaceutical medications and breathing on their own.
I believe in America, I believe in this therapy and I believe in our rights to use our own body to heal. I was not given the opportunity to have a trial and testify in court, but instead the judge ruled based on written summaries prepared by the lawyers. Furthermore, the media, lawyers and others chose to focus on a handful of adverse incidents, ignoring the thousands of positive outcomes that have been documented in the last 20 years around the world.
Recategorizing our own stem cells isolated during a surgical procedure now as “a drug” is exactly what will prevent Americans from having access to this treatment. There isn’t any surgery that is subject to FDA approval, and this fat-derived stem cell procedure shouldn’t be the first one.
There are people who have been healed because of what we do. And, I will tell you that the doctors I have worked with have only the patient’s best interests in mind. They are not “out to get a patient” or “take advantage” of a patient. I’m not that person. We aren’t those people. The narrative that is pushed about “bad actors” is simply not true.
We must respect the judge’s opinion, and we’re no longer performing this life-changing procedure. However, the FDA has never, and should never, control our own cells in our own bodies. Now is the time for the community of patients, scientists and practitioners who care about our rights and the healing power of our cells to rise up. They’re our cells, it should be our choice.
• Kristin Comella is the chief science officer of U.S. Stem Cell Clinic.
Copyright © 2019 The Washington Times, LLC.