The stem cell age is here and is rapidly evolving. The media is saturated with reports, and there is so much hype and promises about stem cell wonders and cures. As clinicians, we are starting to see the potential of cell therapy to achieve organ replacement and repair and, eventually, we will see “stem cells in a bottle” when cell-based therapies obtain FDA approvals. These therapies will take years and hundreds of millions of dollars before they are widely available.
Mainstream stem cell research reflects evidence-based medicine. Another clinical industry of stem cell treatment offers therapies derived from adipose tissue. For various reasons, these centers are gaining acceptance and popularity. The main reason is that some of these centers have good science and ethics and are offering patients treatment options that they cannot obtain in many traditional doctors’ offices.
Second, is that many patients want access to regenerative therapies, but cannot afford to travel overseas where such treatments are more widely available. Third, the regulatory issues that prevent doctors from growing and “manipulating” cells do not apply to same-day surgical procedures that permit physicians to transfer tissues rich in stem cells to damaged areas of the body.
Surgeons have been promoting healing by moving different tissues around the body since the field was created. FDA tissue-handling rules recognize this aspect of medical care, and goes so far to allow these clinics to use stem cells from autologous fat — from one’s own body — which is readily accessible, painlessly acquired, and not at-risk for disease transmission.
Our project got started in 2010. Colleagues in Asia gave my partner, Dr. Mark Berman, an internationally recognized expert on fat grafting procedures, a simple way to procure adult mesenchymal stem cells from lipoharvest fat in the form of stromal vascular fraction (SVF).
We understood that since stromal vascular fraction (SVF) is obtained from autologous tissue in the operating room on the same day, the cell deployment falls under the auspices of a “lipo-transfer” surgical procedure and is not regulated as a laboratory procedure by the FDA.
Stromal Vascular Fraction
All medications and devices used in the procurement are FDA-approved, but used “off-label.” The entire procedure is no different than bladder replacement surgery, where small bowel is used to replace bladder tissue, or a bypass surgery, where a vein from the leg is transferred to the heart to form an artery.
My partner and I quickly realized that we had valuable technology at our disposal, but that we would have to use it judiciously. We set up the California Stem Cell Treatment Center for the investigational use of stromal vascular fraction (SVF) and we obtained Institutional Review Board-approval to study the safety and efficacy of our deployments. IRB’s are governed by the Office of Human Research Protections (a division of the Department of Health and Human Services.
We created an educational website and a multispecialty team to look at treating conditions that required expertise beyond our scope, such as cardiac and orthopedic diseases. Our educational website (www. stemcellrevolution.com) explains that, to support our research, patients would bear the full cost of their care.
We used information and deployment techniques that we obtained from our veterinary colleagues and from reputable centers overseas to optimize our outcomes. We coined the term “cell surgery” because our surgical procedure has no laboratory or manufacturing component, and we wished to distinguish ourselves from the pharmaceutical model of regenerative medicine in which the aim is to monetize a stem cell product as a biologic drug for global distribution.
After all, we were clinicians providing our patients with a surgical regenerative treatment, not a product that comes with a label. We have now performed more than 1,000 cases at our treatment center with extraordinary safety and no adverse effects. Our safety data mimics that seen from the world- wide stromal vascular fraction (SVF) experience.
We have seen astonishing results in wound healing, cardiac function recovery, nerve repair, disease mitigation and arthritis mitigation and treatment of crippling back pain. Many patients have delayed or avoided joint replacement by having stromal vascular fraction (SVF) deployments.
We have helped patients with Peyronies disease – or penile scarring with no effective therapy. We have provided relief for numerous patients with debilitating autoimmune diseases. The uses and various methods of deploying stromal vascular fraction (SVF) are continually growing.
Two years ago, with the understanding that it is important to teach our technology, we started training select physicians to use our techniques to isolate stromal vascular fraction (SVF) and incorporate it in their practices.
We formed a translational research network that includes 65 centers in the United States and facilities as far away as Asia, South Africa, South America and New Zealand. We called the project, Cell Surgical Network.
All network physicians are performing cell surgery using identical protocols that we developed in our centers during the past four years and all are collecting outcomes data in our online advanced database. We have presented our data throughout the world including at the prestigious World Stem Cell Summit in 2013.
Stromal vascular fraction (SVF) deployment is a disruptive technology that allows surgeons to tap the human storehouse of healing cells, taking them from fat and making them “bio-available” for disease mitigation.
Many clinicians in the United States and Europe are waiting for the pharmaceutical industry to provide cell-based therapeutics, but those will come from a laboratory after a prolonged regulatory process.
Others have chosen to use the surgical techniques of stem cell procurement and the knowledge that we have accumulated here and overseas to benefit their patients today.
As with any new industry, many clinics have entered the fray including some without adequate knowledge and training, but interested in riding the regenerative medicine wave. Their websites are full of testimonials and irresponsible claims.
Physicians and consumers need to understand that not all stem cell clinics should be painted with the same broad strokes. Those committed to data collection, that emphasize training, and have IRB oversight should set examples for a model of how we can accelerate the quality of regenerative medicine.
The Cell Surgical Network was the first organization to aspire to these goals and continues to promote our vision of quality regenerative care. We have served as advisors to autologous stem cell policy makers in numerous countries including Australia, the European Union and China.
As patient advocates, our vision is to have safe and cost-effective, cell-based therapies available soon to everyone in the world. A vision we get closer to achieving every day.
About the Author
Dr. Elliot Lander, a board-certified urologist, is co-founder and co-medical director of the California Stem Cell Treatment Center. Dr. Lander has been elected a Fellow of the American College of Surgeons. He has served as chief of urology at Eisenhower Medical Center and chief of surgery at John F. Kennedy Hospital. Dr. Lander has been on staff at Eisenhower Medical Center for 18 years. He is also an Expert Reviewer in Urology for the California Medical Board.
Dr. Lander is involved in cutting edge translational stem cell treatment research at the California Stem Cell Treatment Center based in Rancho Mirage and Beverly Hills, California. He is a member of the International- Cell Surgical Society, a nonprofit organization dedicated to research and education regarding the medical use of adult stem cells.
Dr. Lander and his team of multispecialty experts have pioneered several new techniques in regenerative medicine and have treated patients from across the globe with autologous adult stem cell therapy for degenerative conditions.
Dr. Lander is co-founder of Cell Surgical Network, a nationwide research network dedicated to developing cell surgical techniques studying the clinical applications of adipose derived stem cells and growth factors.