I emailed the CSO of US Stem Cell, Kristin Comella, for any reaction to today’s big news of the DOJ filing suit against two stem cell clinic firms including hers seeking injunctions.
I also emailed the leaders of the other firm, California Stem Cell Treatment Center/Cell Surgical Network. It’s important to include the clinic firms’ perspectives for balance as this story develops.
US Stem Cell’s PR firm and Cell Surgical Network both emailed back.
US Stem Cell has issued a response to the action on their website and here’s a statement that I was sent attributed to Comella:
“My entire career has been dedicated to studying and developing treatments utilizing the body’s own natural ability to heal, and I am devoted to helping others achieve optimal health through therapeutic procedures. It is my life’s work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”
The US Stem Cell response on their website:
“U.S. Stem Cell, Inc. (OTC: USRM), a world leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced its intention to vigorously defend a lawsuit filed today by the U.S. Department of Justice at the request of the U.S. Food and Drug Administration (FDA). The lawsuit seeks to stop US Stem Cell Clinic and related parties from performing a surgical procedure using stem cells from autologous adipose tissue, even when a physician and patient agree that such a procedure is in the best interest of the patient. USRM believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference.”
Notably at the top of the USRM response it says, “USRM Will Vigorously Defend Medical Freedom of Americans”.
And via an email from Dr. Elliot Lander of Cell Surgical Network and California Stem Cell Treatment Center:
“The Cell Surgical Network (CSN) intends to vigorously defend the lawsuit filed today by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration. CSN strongly rejects the idea that a person’s own cells should be regulated by FDA as a drug. On behalf of all Americans, we look forward to protecting patients’ rights and the physician-patient relationship. We share FDA’s concern for patient safety, but do not believe that FDA regulation of a surgical procedure that simply harnesses the healing power of a patient’s own cells, without altering the biological characteristics of those cells, is the answer. The decision of whether or not the surgical procedure is performed should be made by the patient and physician – not the FDA or any other arm of the federal government.”
It’s interesting that there are textual and philosophical similarities in the two statements.
It looks likely that there are going to be more developments in court on the DOJ lawsuit as the clinic firms defend themselves.