The Cell Surgical Network is a large and growing group of affiliated stem cell clinics across the US.
The Network providers use stromal vascular fraction (SVF) interventions for a host of conditions on a for-profit basis. Drs. Elliot Lander and Mark Berman lead the Network.
They agreed to do a Q&A interview with me. Below is Part 1, which delves into the Network itself.
Part 2 on SVF, the FDA, and issues of homologous use can be read here.
Part 3 of this series is my reaction to the interview and to Drs. Lander and Berman’s specific answers.
(2020 update: note that Cell Surgical Network is now in a court battle with the FDA over whether their product can be regulated as a drug).
Here is today’s part of the interview.
1. The Cell Surgical Network is very novel as a linked group of stem cell clinics across the US and some abroad. What is its history? How did it come into being?
Lander: In early 2008, using equipment designed by Dr. Hee Young Lee in South Korea, Dr. Mark Berman, a cosmetic surgeon and an international expert in fat transfer, began isolating concentrated fat for cosmetic uses. With Lee’s technology and further consideration after visits in Japan with Dr. Katoro Yoshimura and others, he quickly realized the therapeutic potential of SVF for degenerative diseases based on extensive animal studies and clinical work in the US, Europe and Asia. Dr. Berman, in collaboration with Dr. Tom Grogan, a Los Angeles orthopedic surgeon, began empirically using intra-articular injections of SVF for various orthopedic uses and found that their experience matched the positive outcomes described in the literature. I became intrigued with their positive results and we began collaborating to develop research protocols to test for safety and efficacy of various methods of SVF deployment for several degenerative conditions. We formed a multispecialty team and developed protocols to treat orthopedic, urologic, cardiovascular, pulmonary, auto-immune, wound care, and several other disease entities.
It became apparent that to achieve the kind of numbers we need to establish safety and efficacy; we would need a multicenter trial performed under the auspices of an IRB. You can find our study on www.clinicaltrial.gov registered under #CSN111. We were interested in teaching our closed surgical procedure to selected physicians around the country and we created the Cell Surgical Network™ to accomplish this in a high quality and standardized fashion. We also employ a full time clinical research coordinator and support a university quality online database to collect valuable outcomes and safety data. Our Cell Surgical Network™ has treated more than 1000 patients with autologous SVF without any serious complications.
2. What is the current status of the Network today? Is it continuing to grow? How do you evaluate clinics that are interested in joining? Do you sometimes turn down applicants and if so, why? Where do you see the Network say in 3-5 years in the future?
Lander: Our network is growing organically and we do not solicit our doctors. Most of them reach out to us based on word of mouth or referral and we select physicians based on reputation and interest in regenerative therapeutics. We have a credentialing process and a standardized and thorough training program to ensure that our affiliate physicians are performing surgical techniques properly and that they are focusing on education and avoiding claims in their interface with the public. We encourage our affiliates to use their multispecialty team members to carefully evaluate applications for SVF deployment to make sure that patients receive appropriate treatment and it is routine for us to decline at least 25% of the patient applications we receive and we often offer free treatments for new diseases if we are attempting to learn more about them. Our goal is to have regenerative therapies available everywhere in the world where surgeons can use patient’s own tissues to help them contend with disease. It is our hope that our Network will play at least a minor role in that vision coming to fruition over the next few years. We certainly will be providing vast amounts of clinical data to the field of regenerative medicine as we accumulate outcomes and safety data and we hope to contribute to improvements in deployment techniques that may be helpful for both autologous and other cell based therapies globally.
3. What are the uniting elements that link the various Network clinics together? A shared philosophy? Do the clinics share methods and apparatus? Do the clinics share an IRB? If so, what is the IRB?
Lander: Our clinics are all independently owned but share our ICMS IRB and use the same training, methods and equipment. In order to provide meaningful data, it is imperative that we are all doing the same protocols. We share the same online database and we share the same mission statements, commitment to ethical practice, and vision of advancing our field and making cell based therapy readily available.
4. An Internet search suggests you use the Lipokit by Medikan to produce stromal vascular fraction (SVF)?. Why did you pick that approach and how has it worked for you & the Network clinics?
Lander: We use the MediKan equipment – now branded as the CSN – Time Machine™ because my partner, Dr. Berman originally obtained this equipment in 2008 and then upon visiting Japan and watching Dr. Kamakura with the Cytori machine and Dr. Yoshimura with the same MediKan equipment made an obvious decision. If it was good enough for Kotaro Yoshimura, arguably one of the top SVF / fat specialists in the world, it was good enough for us. We just needed a safe GMP grade enzyme – which came along in July 2010 thanks to Roche Laboratories. We just had to refine the system so that it was completely closed, sterile and provided filtered cells. This has allowed us to reliably produce excellent quality SVF and no culturing or cell manipulation is required. There is no laboratory aspect to our SVF procurement.
Stay tuned for Part 2.