The Cell Surgical Network is one of the largest groups of physicians investigating the deployment of stromal vascular fraction (SVF, which contains adipose derived stem cells) for cellular degenerative conditions. The regenerative medical field truly represents a new era in medicine, one in which otherwise dormant cells from your own body are made bio-available to replace and repair degenerative cells and tissues elsewhere in your body. SVF and cell deployment is exciting and potentially absolutely transformative. It is for this reason that the Cell Surgical Network was founded and has pioneered its way through this field in the most responsible way possible. The Cell Surgical Network instituted IRB approved protocols and an online HIPAA compliant database to govern and oversee all of the cases performed in our Network. Every patient is followed up with to evaluate safety and efficacy of their surgical procedure. The data is collected, stratified, and shared amongst our affiliates, peers, and colleagues, even publically through peer reviewed publications. This goes beyond how surgery is typically advanced, but is ultimately appropriate, responsible and scientifically forward thinking.
FDA inspectors recently visited the California Stem Cell Treatment Center, part of the Cell Surgical Network. We were proud to let the inspectors in and show them every facet of our meticulous operation. After sharing with and educating the inspectors as much as we did, as well as submitting multiple IDE and IND applications to the FDA, we are disappointed to see FDA director, Dr. Gottlieb’s disparaging and misrepresentative comments about the California Stem Cell Treatment Center today. His comments show a lack of understanding surrounding autologous surgical procedures. They also completely misrepresent the California Stem Cell Treatment Center’s pilot study with StemImmune, which delivers cutting edge cancer therapy to stage 4 plus cancer patients. All potential patients are screened and approved by a tumor board and therapies performed under IRB approved protocols. Many top national and international doctors and scientists are participating in this study, including our nation’s own Department of Defense. Not once was a patient in this cancer study ever charged for any of these treatments.
We fully understand the FDA’s role in protecting the American consumer and patient. We understand their desire to regulate this new field of regenerative medicine and look forward to working with them to do so, as we have for the past few years now.