As you all know, we are vigorously fighting the FDA lawsuit seeking a permanent injunction to stop us from providing SVF as a point of care product to our patients. SVF is not a drug and FDA attempts to regulate our PERSONAL CELLS is a violation of our constitutional rights, a huge over-reach, inconsistent with rules they rely upon, and simply the antithesis of our duties as physicians.
Part of our strategy with the courts will be to present a compendium from our physicians of our professional testimonials along with a sampling from our patients. We already have a significant trove of patient data compiled by CSN over the last 6 years. We have excellent safety data and we have continued to work with the FDA on our IDE application. We hired the company Exponent, hoping they would help us shore up the few remaining deficiencies that mostly deal with technical issues with the Korean made centrifuge and incubator.
The physician testimonial should come from you and your associate physicians describing our experiences participating in these investigational efforts with adipose SVF. CSN is comprised of many elite physicians and leaders of their field, and we ask that you consider including the scope of your experience and credentials in your testimonial. Additionally, we’d like you to request responses from your patients.
Many of our patients have already provided unprovoked testimonials but now we must request that they help us stand up for our and all patients’ rights.
Our patients own their own cells. They are responsible for the “manufacture” of their cells. Our job is to simply procure them through a minor surgical procedure. We know of no pharmaceutical company that would ever consider an FDA application for something they didn’t manufacture and own. We must stand up for our patients’ rights and the rights of doctors to perform surgery without the FDA stepping into our arena. Doctors have become the sheep of the healthcare industry and enough is enough.
If the FDA and the Pharmaceutical industry can come up with something better than surgically derived PERSONAL CELL THERAPY then let them do it and we’ll all convert to an off the shelf pharmaceutical. However, please understand that there is no human product that as yet can be validated for complete sterility. It’s one thing to get a blood transfusion on an emergency basis or even allogeneic stem cells during a possible emergency. In spite of screening for basic viruses (e.g. hepatitis, HIV, etc.) there may be any number of virions and prions that could go undetected. Additionally, there is now good evidence that screened, matched allogeneic bone marrow transplants can later produce serious and even deadly, graft versus host disease. With allogeneic stem cell use for somatic cell repair long term effects from are unknown and logic tells us will likely result in an ultimate response from our body’s immune cells against our tissues much like any organ transplant.
Please send your testimonials (personal and patients) within the next several weeks – the sooner the better. You and your patients can upload them directly to our website at https://stemcellrevolution.com/patient-survey/ or email them to Sean directly at Sean@cellsurgicalnetwork.com.
We will win this battle.