About the Cell Surgical Network
The Cell Surgical Network was founded nearly two years after the formation of the California Stem Cell Treatment Center (founded in 2010). Affiliate members are generally made up of teams of multidisciplinary physicians in order to best assess and provide care for our patients. The Cell Surgical Network emphasizes quality and is highly committed to clinical research and the advancement of regenerative medicine.
Currently, all affiliate members use the same sterile closed surgical procedure to process fat using a mini-liposuction procedure in order to isolate and implant a patient’s own source of regenerative cells on the same day. The source of the regenerative cells actually comes from stromal vascular fraction (SVF) – a protein rich segment from processed adipose tissue. Stromal vascular fraction contains a mononuclear cell line (predominantly autologous mesenchymal stem cells), macrophage cells, endothelial cells, red blood cells, and important growth factors that facilitate the stem cell process and promote their activity. Our technology allows us to isolate high numbers of viable cells that we can deploy during the same surgical setting. While vigilant about patient safety, we are also learning about which diseases respond best and which deployment methods are most effective. CSN employs a clinical research coordinator and an online database to collect valuable data from throughout the network of affiliates. Affiliates have the opportunity to share not only their data, but their experiences thus helping each other to higher levels of understanding and care.
About Mark Berman MD
Mark Berman Co-Medical Director Dr. Berman, the 2010 President of the American Academy of Cosmetic Surgery, has been in private practice in the West Los Angeles area since 1983 and has been practicing in the Desert Area since 2003. Dr. Berman graduated from UCLA prior to completing medical school at the Chicago Medical School. He is a clinical instructor in facial plastic surgery through the University of Southern California. Dr. Berman is a Diplomate with the American Board of Cosmetic Surgery and the American Board of Otolaryngology (Head and Neck Surgery). He is a Fellow of the American College of Surgeons. Los Angeles Magazine has named him one of the Top Doctors in Southern California. Dr. Berman is well known for his work with stem cell / fat grafting to restore three-dimensional volume to the aging face. This has led him to his work with adipose derived stem cells. He is also known as a pioneer in the use of Gore-Tex materials in cosmetic surgery. He holds a patent on an e-PTFE breast implant device – the Pocket Protector – used to improve breast augmentation surgery. He has also authored a novel – Substance of Abuse – a controversial sexy thriller that suggests a solution to the war on drugs. Dr. Berman and his wife, Saralee, have one son, Sean, two dogs and two turtles.
About Elliot Lander MD
Co-Medical Director Elliot B. Lander, M.D.F.A.C.S. is a Board-Certified Surgeon. He was born in Los Angeles, California. He graduated Magna Cum Laude and Phi Beta Kappa from Occidental College with Distinction in Biochemistry. He attended medical school at the University of California, Irvine. For six years after medical school, Dr. Lander studied General Surgery and then Urologic Surgery at the University of California, Irvine. He was a Clinical Assistant Professor of Urology at the same institution while in practice at a large HMO in Orange County for five years. During that time he was active in teaching residents and doing research. He has many publications in the urologic literature. Dr. Lander has been elected as 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 for fourteen years. He is also an Expert Reviewer for the California Medical Board. Dr. Lander is currently involved in cutting edge urologic stem cell treatment research and is a member of the International Cellular Medicine Society, a global nonprofit organization dedicated to patient safety and education regarding the medical use of adult stem cells. Dr. Lander specializes in Male Hormone Replacement and has developed special protocols to administer male hormones safely in men with a history of prostate cancer.
To contact Cell Surgical Network:
CSCTC. (800) 231-0407
CSN. Info@cellsurgicalnetwork.com
CSN website. http://Stemcellrevolution.com
To contact Dr. Berman directly:
Mark Berman, MD, FACS
2010 - President - American Academy of Cosmetic Surgery
http://www.cosmeticsurgery.org
120 S. Spalding Drive, Suite 300
Beverly Hills, CA 90212
310 274-2789
fax 310 943-1960
http://www.markbermanmd.com
http://www.stemcellrevolution.com
Questions & Answers
Q: I keep hearing from people that got a stem cell injection instead of a knee replacement that it works great - at a fraction of the cost, too. What's it going to take for stem cells to become the new standard of treatment for knees instead of surgery?
Answer from Lander: Cell based therapies, as they develop, may play a large role in osteoarthritis. We have to gain a deeper understanding of which cells work best and for which patients. Some patients will require surgery and clearly there is a subset of patients that may respond to one or a series of stem cell based deployments. Identifying which patients should be offered cell therapy is an important goal of our brand of research and we therefore keep meticulous records on all our patients. Currently cell therapies cost much less than a surgical procedure but the insurance industry understands that demand could rise quickly if non-invasive therapies like stem cells are “approved” and this could prove expensive for them. If you bypass the epidemiologists, economists, and insurance industry wonks and ask doctors and patients, they will tell you that it is absolutely vital to have non surgical options to joint replacement surgery for our aging and athletic population.
Answer from Berman: Surgery will always have its place, however, stem cell therapy may significantly reduce the number of total knee replacements. Currently, most arthritic knees are treated with a variety of medications – starting with NSAIDS (anti-inflammatories) then corticosteroid injections and also hyaluronic acid fillers). If treated instead, while there’s still cartilage present, then SVF (stromal vascular fraction rich in stem cells) or stem cells will help much more and actually regenerate new healthy cartilage. Once there has been enough data collected showing this to work (and we’re getting close), then it’s likely insurance companies will start urging their patients to consider this type of care – particularly as it will save the insurance company so much money.
Q: I wonder if stem cell therapy (today, not in the future) could help people with chronic venous insufficiency, e.g. intravenous administration of stem cells or mobilization with G-CSF. This does seem to work in cases of peripheral arterial disease, but maybe venous disease is a whole different story. Do you believe treatment would improve/regenerate vein walls or it this unlikely?
Answer from Lander: We have limited experience with venous congestion syndromes and regeneration of vein walls. Some of our ED work crosses into the spectrum of repair of micro-vasculopathy and some of the critical limb ischemia data supports repair of micro and macro vasculature but the venous system is not exactly the same.
Although certain growth factors are known to stimulate stem cell activity, we have to be careful when considering products that “mobilize” stem cells. Many vendors are touting supplements or drugs that allegedly “mobilize” stem cells but data confirming that and translating into some type of improved clinical outcome is very scant. Caveat Emptor- let the buyer beware.
Q: I am dealing with a form of dysautonomia that isn't entirely understood yet here in America. I have "adrenal fatigue" which is not a true medical diagnosis, but is rather a set of symptoms related to low functioning adrenal glands. My biggest issues are: fatigue, insomnia, mood swings, nausea, lack of appetite, dizziness, muscle weakness, brain fog, depression, anxiety, low stress tolerance and lacking motivation. This list may appear entirely psychological to some, but I assure you that its gotten so bad I had to stop working for awhile. I tried various psych medications and those often made things worse. I tend to get a very high pulse rate when standing and it adds to the fatigue. I am only 26 years old and have hope I can find a treatment to help me out. What about stem cell therapy?
Answer from Lander: We have some limited and circumstantial evidence that cell based therapies may favorable influence the endocrine system but to our knowledge, meaningful data regarding adrenal degeneration is lacking. We occasionally face degenerative diseases that are poorly understood and we use cell therapy empirically since side effects are minimal. Under such conditions, we are sometimes favorably impressed with outcomes but patients must know going into that situation that potential results are unknown and expectations should be guarded accordingly.
Answer from Berman: Stem cell therapy is likely the only REAL way of correcting the situation. Ideally, the stem cells recognize the glandular damage and the cells, under the influence of the growth factors in that area, can then regenerate new adrenal tissue and reverse your condition. Experimentally, SVF has been converted into a wide variety of glandular elements, so it may indeed work in your situation.
Q: Cell Surgical Network has treated over 1000 patients and lists a wide variety of diseases that are under study. Can you characterize outcomes yet for any of these conditions and are any showing surprising efficacy? What is the target date for publication of these studies?
Answer from Lander: We continue to be surprised by the efficacy of our relatively small number of cardiac patients. We are preparing a paper currently under the direction of Dr. See our partner who is an interventional cardiologist. In all of these patients, quality of life scores and ejection fractions appear to have shown dramatic improvement after deploying SVF.
Answer from Berman: Dr. Lander and I have the draft for the paper nearly complete. The initial publication had safety as its primary objective, but we’re also looking at a number of outcomes. Most of the orthopedic, particularly, arthritic conditions, seem to respond very nicely. Certainly, our positive responses seem to be 85% or more. It’s been interesting to see how some conditions, such as wrist arthritis, seem to respond very rapidly, while others, such as shoulder conditions, may take up to three months to show a positive response. We have several patients that have remained pain free beyond three years and that’s also an interesting finding since we have little idea how long improvements will be sustained. There have been some surprising improvements in wheelchair bound paraplegics that note improvements.
We’ve seen a host of improvements in various neurodegenerative areas. These are more difficult to predict. Interestingly, these patients often even have problems with their bowel movements and will report a return to normal bowel function – something of great relief to them for obvious reasons. My partner, Dr. Lander, has made some startling improvements in the area of Interstitial Cystitis a generally impossible disease to reverse. SVF does very well in pulmonary and cardiac conditions and it’s incredibly gratifying to see most of these patients get better with conditions that are otherwise untreatable unless a transplant is done.
Q: Can you describe the amount of mesenchymal stem cells (MSC's) that are in a typical stromal vascular fraction (SVF) treatment and is that where the majority of the therapeutic effect comes from?
Answer from Berman: SVF is a lovely soup made up of stem cells (pre-adipocytes, stem cells within the blood vessel walls, pericytes or stem cells lying on blood vessels, and a few stem cells circulating in blood), white blood cells, red blood cells, endothelial cells, platelets and growth factors. In the average person, once we remove and then concentrate 25cc of their fat, they may yield 10 – 30 million actual stem cells. The majority of the therapeutic effect likely comes from conversion of the stem cell to the new cellular component it needs to replace. The stem cell is essentially the building material, however, it’s triggered by the growth factors that must dictate and direct it into what to become.
Q: What are the other components of SVF that yield healing effects?
Answer from Lander: SVF is like a biologic soup that is rich in both cells and growth factors which are the cytokine signaling molecules that synergize with the cells for clinical effect. Cell types are a mixture of 2 main different types of stem cells (pre-adipocytes and perivascular stem cells) and also one can find T regulatory cells, monocytes, epithelial cells, dendritic cells, red blood cells, and many others. SVF may have distinct properties from adipose derived stem cells that are obtained by laboratory culture. Since there is no laboratory aspect to our surgical procedures, we are able to exploit the native properties of this natural biologic that is readily available just under our skin and easily mobilized as part of a surgical procedure. That is why we call what we are doing “Cell Surgery.”
Answer from Berman: I think there is a useful analogy for understanding stem cells that are found in different locations. As Dr. Lander noted, the two main sources of stem cells in fat are within the fat (pre-adipocytes) or within the blood vessel walls. There are also some found on the blood vessels (pericytes) and a few floating within the blood (bone marrow derived). Fundamentally, imagine an envelope filled with your DNA but with different addresses on it. Perhaps, there’s one addressed to the fat, or to the blood vessels, or to your skin, or any of your organs. Until those envelopes are given the special instructions (growth factors) that tell the DNA what it needs to become, they are probably very much alike – they only have different addresses. The pre-adipocyte within fat will likely become a fat cell because it will get exposed to those growth factors for obvious reasons (location, location, location). However, we know that when we take that pre-adipocyte out of the fat and place it in a different environment, such as an arthritic knee, it will become exposed to cartilage growth factors and can then transform into cartilage. Thus, the address on the envelope just tells you where the stem cell is but not necessarily what it needs to become (if you move it).
Q: I have had CIDP since 2011. It has resulted in axonal degeneration. I have succeeded in stopping the disease. Is there a way to inject stem cells into the spinal cord and regenerate the nerve and reconnect the muscles? I walk with a walker now.
Answer from Lander: We have treated several cases of CIDP with good but not long term results. The key is to work on the immune system and SVF delivered intravenously is effective at immune-modulation (not immunosuppression). This works well since CIDP is an autoimmune disease. For patients that we feel may benefit from CNS deployment, we have the capacity to inject directly into brain ventricles under one of our IRB approved protocols and this is done with a neurosurgeon.
Answer from Berman: We’ve had some reasonable results treating CIDP. The number of patients treated is very limited and as such there’s no way we can say for certainty how we would predict one would respond. While we’re quite certain you need to repair your tissues with healthy cells, there’s no way of knowing how much damage already exists and therefore how many cells will eventually be needed to heal or improve your current condition. Most likely, it will be much better to treat someone at the earliest signs of these diseases. As Dr. Lander noted, these cells are immuno-modulatory, but we may need a more thorough approach with some type of immunosuppression to knock out the cells attacking the native tissues.
Q: Can someone with COPD, dependent on supplemental oxygen 24/7 ever hope to be able to get off oxygen with the types of treatment currently available? Do you see a future in scaffolding for lung disease or what is the next generation of improved therapy over what is currently available?
Answer from Lander: More than 80% of the cells in SVF naturally sink to the lungs after intravenous infusion. This has allowed us to treat patients with COPD in combination with nebulized SVF. We have not used scaffolding and it would be interesting to see if outcomes were superior if cells are deployed differently. We have studied several innovative deployment methods for many of the conditions we treat that someday may be a part of cell therapy regardless of which type of cell is used. We have had patients who have been able to completely get off oxygen but we have also had a few patients that did not respond at all in any significant way. Overall, COPD and emphysema have been successful programs for us.
Q: The FDA doesn't allow doctors in the U.S. to administer cells expanded in the lab to reach a higher dose. But for neurodegenerative diseases like MS and ALS, major research institutions like Cleveland Clinic, Tisch and Mayo Clinic are doing trials with doses of 100 million MSC's. Patients with MS have been reporting good results for years with SVF which yields a smaller dose of MSC's, but what kind of results can be expected from SVF for a serious condition like ALS?
Answer from Lander: We have seen an approximately 60% response rate on ALS. We will know more as we further explore our CNS deployment protocols.
Answer from Berman: ALS would likely respond to SVF and we’ve seen some limited positive responses. However, as I mentioned before, by the time we often see these patients, their disease has progressed so far that we are essentially throwing a cup of water on a raging fire. It would likely be far better to catch these conditions in their earlier stages before the cell damage gets too out of control.
Q: Senator Boxer has a proposed Regenerative Medicine Act in the works, but it lacks the provision the Japanese have included in their Regenerative Medicine Act for accelerated approval of cellular therapies after safety is established. Is there any way Congress could improve the outlook for regenerative medicine in the U.S.?
Answer from Lander: Congress has already provided for surgical procedures to remain within the physician’s scope of practice and drugs and devices to be regulated by the FDA. In the future, Congress may be required to draw clearer lines of distinction as fields like “cell surgery” develop which may appear to blur the technological lines between surgery and non-surgical therapies. For us as physicians, it is clear that observing surgical sterility and protecting patients from the transmission of disease is of paramount importance and that it is imperative to use any safe technology to try to help our patients.
Answer from Berman: Yes – get out of the way. Doctors and their patients need to work together. Science needs to work with doctors and the regulatory agencies need to get out of the way. We probably would have had cures and treatments for these conditions if it wasn’t for the obstruction of the government. The government would argue that medicine would run amuck and kill countless people while charlatan doctors exploited these helpless individuals. However, we already have state medical boards and a limitless supply of attorneys that can keep such negligent practices in check. Because CSN actually produces SVF under strictly closed surgical techniques and not through laboratory processes, we’ve been able to start these empirical evaluations and actually make some very meaningful observations while others are stuck in the lab or still don’t know if what they are working on will have any merit. Nonetheless, there is a plethora of stem cell laboratories and university projects moving forward, so real breakthroughs will continue. The government has rarely been helpful in any of these endeavors and at this point isn’t really necessary to move things forward unless they want to end the multitude of regulatory hurdles.
Q: I am a 39 year old male who has urinary stricture disease. I have been told my bladder is like someone who is 90 years old. I have had surgery, but was told that may not be a permanent solution. Would stem cell therapy produce a more lasting, positive outcome?
Answer from Lander: Complex situations like this must be evaluated on a case by case basis. We have experience injecting urethral strictures with stem cells and we are hopeful that we will continue to see good results since SVF is capable of mitigating many types of scar tissue.
The Cell Surgical Network was founded nearly two years after the formation of the California Stem Cell Treatment Center (founded in 2010). Affiliate members are generally made up of teams of multidisciplinary physicians in order to best assess and provide care for our patients. The Cell Surgical Network emphasizes quality and is highly committed to clinical research and the advancement of regenerative medicine.
Currently, all affiliate members use the same sterile closed surgical procedure to process fat using a mini-liposuction procedure in order to isolate and implant a patient’s own source of regenerative cells on the same day. The source of the regenerative cells actually comes from stromal vascular fraction (SVF) – a protein rich segment from processed adipose tissue. Stromal vascular fraction contains a mononuclear cell line (predominantly autologous mesenchymal stem cells), macrophage cells, endothelial cells, red blood cells, and important growth factors that facilitate the stem cell process and promote their activity. Our technology allows us to isolate high numbers of viable cells that we can deploy during the same surgical setting. While vigilant about patient safety, we are also learning about which diseases respond best and which deployment methods are most effective. CSN employs a clinical research coordinator and an online database to collect valuable data from throughout the network of affiliates. Affiliates have the opportunity to share not only their data, but their experiences thus helping each other to higher levels of understanding and care.
About Mark Berman MD
Mark Berman Co-Medical Director Dr. Berman, the 2010 President of the American Academy of Cosmetic Surgery, has been in private practice in the West Los Angeles area since 1983 and has been practicing in the Desert Area since 2003. Dr. Berman graduated from UCLA prior to completing medical school at the Chicago Medical School. He is a clinical instructor in facial plastic surgery through the University of Southern California. Dr. Berman is a Diplomate with the American Board of Cosmetic Surgery and the American Board of Otolaryngology (Head and Neck Surgery). He is a Fellow of the American College of Surgeons. Los Angeles Magazine has named him one of the Top Doctors in Southern California. Dr. Berman is well known for his work with stem cell / fat grafting to restore three-dimensional volume to the aging face. This has led him to his work with adipose derived stem cells. He is also known as a pioneer in the use of Gore-Tex materials in cosmetic surgery. He holds a patent on an e-PTFE breast implant device – the Pocket Protector – used to improve breast augmentation surgery. He has also authored a novel – Substance of Abuse – a controversial sexy thriller that suggests a solution to the war on drugs. Dr. Berman and his wife, Saralee, have one son, Sean, two dogs and two turtles.
About Elliot Lander MD
Co-Medical Director Elliot B. Lander, M.D.F.A.C.S. is a Board-Certified Surgeon. He was born in Los Angeles, California. He graduated Magna Cum Laude and Phi Beta Kappa from Occidental College with Distinction in Biochemistry. He attended medical school at the University of California, Irvine. For six years after medical school, Dr. Lander studied General Surgery and then Urologic Surgery at the University of California, Irvine. He was a Clinical Assistant Professor of Urology at the same institution while in practice at a large HMO in Orange County for five years. During that time he was active in teaching residents and doing research. He has many publications in the urologic literature. Dr. Lander has been elected as 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 for fourteen years. He is also an Expert Reviewer for the California Medical Board. Dr. Lander is currently involved in cutting edge urologic stem cell treatment research and is a member of the International Cellular Medicine Society, a global nonprofit organization dedicated to patient safety and education regarding the medical use of adult stem cells. Dr. Lander specializes in Male Hormone Replacement and has developed special protocols to administer male hormones safely in men with a history of prostate cancer.
To contact Cell Surgical Network:
CSCTC. (800) 231-0407
CSN. Info@cellsurgicalnetwork.com
CSN website. http://Stemcellrevolution.com
To contact Dr. Berman directly:
Mark Berman, MD, FACS
2010 - President - American Academy of Cosmetic Surgery
http://www.cosmeticsurgery.org
120 S. Spalding Drive, Suite 300
Beverly Hills, CA 90212
310 274-2789
fax 310 943-1960
http://www.markbermanmd.com
http://www.stemcellrevolution.com
Questions & Answers
Q: I keep hearing from people that got a stem cell injection instead of a knee replacement that it works great - at a fraction of the cost, too. What's it going to take for stem cells to become the new standard of treatment for knees instead of surgery?
Answer from Lander: Cell based therapies, as they develop, may play a large role in osteoarthritis. We have to gain a deeper understanding of which cells work best and for which patients. Some patients will require surgery and clearly there is a subset of patients that may respond to one or a series of stem cell based deployments. Identifying which patients should be offered cell therapy is an important goal of our brand of research and we therefore keep meticulous records on all our patients. Currently cell therapies cost much less than a surgical procedure but the insurance industry understands that demand could rise quickly if non-invasive therapies like stem cells are “approved” and this could prove expensive for them. If you bypass the epidemiologists, economists, and insurance industry wonks and ask doctors and patients, they will tell you that it is absolutely vital to have non surgical options to joint replacement surgery for our aging and athletic population.
Answer from Berman: Surgery will always have its place, however, stem cell therapy may significantly reduce the number of total knee replacements. Currently, most arthritic knees are treated with a variety of medications – starting with NSAIDS (anti-inflammatories) then corticosteroid injections and also hyaluronic acid fillers). If treated instead, while there’s still cartilage present, then SVF (stromal vascular fraction rich in stem cells) or stem cells will help much more and actually regenerate new healthy cartilage. Once there has been enough data collected showing this to work (and we’re getting close), then it’s likely insurance companies will start urging their patients to consider this type of care – particularly as it will save the insurance company so much money.
Q: I wonder if stem cell therapy (today, not in the future) could help people with chronic venous insufficiency, e.g. intravenous administration of stem cells or mobilization with G-CSF. This does seem to work in cases of peripheral arterial disease, but maybe venous disease is a whole different story. Do you believe treatment would improve/regenerate vein walls or it this unlikely?
Answer from Lander: We have limited experience with venous congestion syndromes and regeneration of vein walls. Some of our ED work crosses into the spectrum of repair of micro-vasculopathy and some of the critical limb ischemia data supports repair of micro and macro vasculature but the venous system is not exactly the same.
Although certain growth factors are known to stimulate stem cell activity, we have to be careful when considering products that “mobilize” stem cells. Many vendors are touting supplements or drugs that allegedly “mobilize” stem cells but data confirming that and translating into some type of improved clinical outcome is very scant. Caveat Emptor- let the buyer beware.
Q: I am dealing with a form of dysautonomia that isn't entirely understood yet here in America. I have "adrenal fatigue" which is not a true medical diagnosis, but is rather a set of symptoms related to low functioning adrenal glands. My biggest issues are: fatigue, insomnia, mood swings, nausea, lack of appetite, dizziness, muscle weakness, brain fog, depression, anxiety, low stress tolerance and lacking motivation. This list may appear entirely psychological to some, but I assure you that its gotten so bad I had to stop working for awhile. I tried various psych medications and those often made things worse. I tend to get a very high pulse rate when standing and it adds to the fatigue. I am only 26 years old and have hope I can find a treatment to help me out. What about stem cell therapy?
Answer from Lander: We have some limited and circumstantial evidence that cell based therapies may favorable influence the endocrine system but to our knowledge, meaningful data regarding adrenal degeneration is lacking. We occasionally face degenerative diseases that are poorly understood and we use cell therapy empirically since side effects are minimal. Under such conditions, we are sometimes favorably impressed with outcomes but patients must know going into that situation that potential results are unknown and expectations should be guarded accordingly.
Answer from Berman: Stem cell therapy is likely the only REAL way of correcting the situation. Ideally, the stem cells recognize the glandular damage and the cells, under the influence of the growth factors in that area, can then regenerate new adrenal tissue and reverse your condition. Experimentally, SVF has been converted into a wide variety of glandular elements, so it may indeed work in your situation.
Q: Cell Surgical Network has treated over 1000 patients and lists a wide variety of diseases that are under study. Can you characterize outcomes yet for any of these conditions and are any showing surprising efficacy? What is the target date for publication of these studies?
Answer from Lander: We continue to be surprised by the efficacy of our relatively small number of cardiac patients. We are preparing a paper currently under the direction of Dr. See our partner who is an interventional cardiologist. In all of these patients, quality of life scores and ejection fractions appear to have shown dramatic improvement after deploying SVF.
Answer from Berman: Dr. Lander and I have the draft for the paper nearly complete. The initial publication had safety as its primary objective, but we’re also looking at a number of outcomes. Most of the orthopedic, particularly, arthritic conditions, seem to respond very nicely. Certainly, our positive responses seem to be 85% or more. It’s been interesting to see how some conditions, such as wrist arthritis, seem to respond very rapidly, while others, such as shoulder conditions, may take up to three months to show a positive response. We have several patients that have remained pain free beyond three years and that’s also an interesting finding since we have little idea how long improvements will be sustained. There have been some surprising improvements in wheelchair bound paraplegics that note improvements.
We’ve seen a host of improvements in various neurodegenerative areas. These are more difficult to predict. Interestingly, these patients often even have problems with their bowel movements and will report a return to normal bowel function – something of great relief to them for obvious reasons. My partner, Dr. Lander, has made some startling improvements in the area of Interstitial Cystitis a generally impossible disease to reverse. SVF does very well in pulmonary and cardiac conditions and it’s incredibly gratifying to see most of these patients get better with conditions that are otherwise untreatable unless a transplant is done.
Q: Can you describe the amount of mesenchymal stem cells (MSC's) that are in a typical stromal vascular fraction (SVF) treatment and is that where the majority of the therapeutic effect comes from?
Answer from Berman: SVF is a lovely soup made up of stem cells (pre-adipocytes, stem cells within the blood vessel walls, pericytes or stem cells lying on blood vessels, and a few stem cells circulating in blood), white blood cells, red blood cells, endothelial cells, platelets and growth factors. In the average person, once we remove and then concentrate 25cc of their fat, they may yield 10 – 30 million actual stem cells. The majority of the therapeutic effect likely comes from conversion of the stem cell to the new cellular component it needs to replace. The stem cell is essentially the building material, however, it’s triggered by the growth factors that must dictate and direct it into what to become.
Q: What are the other components of SVF that yield healing effects?
Answer from Lander: SVF is like a biologic soup that is rich in both cells and growth factors which are the cytokine signaling molecules that synergize with the cells for clinical effect. Cell types are a mixture of 2 main different types of stem cells (pre-adipocytes and perivascular stem cells) and also one can find T regulatory cells, monocytes, epithelial cells, dendritic cells, red blood cells, and many others. SVF may have distinct properties from adipose derived stem cells that are obtained by laboratory culture. Since there is no laboratory aspect to our surgical procedures, we are able to exploit the native properties of this natural biologic that is readily available just under our skin and easily mobilized as part of a surgical procedure. That is why we call what we are doing “Cell Surgery.”
Answer from Berman: I think there is a useful analogy for understanding stem cells that are found in different locations. As Dr. Lander noted, the two main sources of stem cells in fat are within the fat (pre-adipocytes) or within the blood vessel walls. There are also some found on the blood vessels (pericytes) and a few floating within the blood (bone marrow derived). Fundamentally, imagine an envelope filled with your DNA but with different addresses on it. Perhaps, there’s one addressed to the fat, or to the blood vessels, or to your skin, or any of your organs. Until those envelopes are given the special instructions (growth factors) that tell the DNA what it needs to become, they are probably very much alike – they only have different addresses. The pre-adipocyte within fat will likely become a fat cell because it will get exposed to those growth factors for obvious reasons (location, location, location). However, we know that when we take that pre-adipocyte out of the fat and place it in a different environment, such as an arthritic knee, it will become exposed to cartilage growth factors and can then transform into cartilage. Thus, the address on the envelope just tells you where the stem cell is but not necessarily what it needs to become (if you move it).
Q: I have had CIDP since 2011. It has resulted in axonal degeneration. I have succeeded in stopping the disease. Is there a way to inject stem cells into the spinal cord and regenerate the nerve and reconnect the muscles? I walk with a walker now.
Answer from Lander: We have treated several cases of CIDP with good but not long term results. The key is to work on the immune system and SVF delivered intravenously is effective at immune-modulation (not immunosuppression). This works well since CIDP is an autoimmune disease. For patients that we feel may benefit from CNS deployment, we have the capacity to inject directly into brain ventricles under one of our IRB approved protocols and this is done with a neurosurgeon.
Answer from Berman: We’ve had some reasonable results treating CIDP. The number of patients treated is very limited and as such there’s no way we can say for certainty how we would predict one would respond. While we’re quite certain you need to repair your tissues with healthy cells, there’s no way of knowing how much damage already exists and therefore how many cells will eventually be needed to heal or improve your current condition. Most likely, it will be much better to treat someone at the earliest signs of these diseases. As Dr. Lander noted, these cells are immuno-modulatory, but we may need a more thorough approach with some type of immunosuppression to knock out the cells attacking the native tissues.
Q: Can someone with COPD, dependent on supplemental oxygen 24/7 ever hope to be able to get off oxygen with the types of treatment currently available? Do you see a future in scaffolding for lung disease or what is the next generation of improved therapy over what is currently available?
Answer from Lander: More than 80% of the cells in SVF naturally sink to the lungs after intravenous infusion. This has allowed us to treat patients with COPD in combination with nebulized SVF. We have not used scaffolding and it would be interesting to see if outcomes were superior if cells are deployed differently. We have studied several innovative deployment methods for many of the conditions we treat that someday may be a part of cell therapy regardless of which type of cell is used. We have had patients who have been able to completely get off oxygen but we have also had a few patients that did not respond at all in any significant way. Overall, COPD and emphysema have been successful programs for us.
Q: The FDA doesn't allow doctors in the U.S. to administer cells expanded in the lab to reach a higher dose. But for neurodegenerative diseases like MS and ALS, major research institutions like Cleveland Clinic, Tisch and Mayo Clinic are doing trials with doses of 100 million MSC's. Patients with MS have been reporting good results for years with SVF which yields a smaller dose of MSC's, but what kind of results can be expected from SVF for a serious condition like ALS?
Answer from Lander: We have seen an approximately 60% response rate on ALS. We will know more as we further explore our CNS deployment protocols.
Answer from Berman: ALS would likely respond to SVF and we’ve seen some limited positive responses. However, as I mentioned before, by the time we often see these patients, their disease has progressed so far that we are essentially throwing a cup of water on a raging fire. It would likely be far better to catch these conditions in their earlier stages before the cell damage gets too out of control.
Q: Senator Boxer has a proposed Regenerative Medicine Act in the works, but it lacks the provision the Japanese have included in their Regenerative Medicine Act for accelerated approval of cellular therapies after safety is established. Is there any way Congress could improve the outlook for regenerative medicine in the U.S.?
Answer from Lander: Congress has already provided for surgical procedures to remain within the physician’s scope of practice and drugs and devices to be regulated by the FDA. In the future, Congress may be required to draw clearer lines of distinction as fields like “cell surgery” develop which may appear to blur the technological lines between surgery and non-surgical therapies. For us as physicians, it is clear that observing surgical sterility and protecting patients from the transmission of disease is of paramount importance and that it is imperative to use any safe technology to try to help our patients.
Answer from Berman: Yes – get out of the way. Doctors and their patients need to work together. Science needs to work with doctors and the regulatory agencies need to get out of the way. We probably would have had cures and treatments for these conditions if it wasn’t for the obstruction of the government. The government would argue that medicine would run amuck and kill countless people while charlatan doctors exploited these helpless individuals. However, we already have state medical boards and a limitless supply of attorneys that can keep such negligent practices in check. Because CSN actually produces SVF under strictly closed surgical techniques and not through laboratory processes, we’ve been able to start these empirical evaluations and actually make some very meaningful observations while others are stuck in the lab or still don’t know if what they are working on will have any merit. Nonetheless, there is a plethora of stem cell laboratories and university projects moving forward, so real breakthroughs will continue. The government has rarely been helpful in any of these endeavors and at this point isn’t really necessary to move things forward unless they want to end the multitude of regulatory hurdles.
Q: I am a 39 year old male who has urinary stricture disease. I have been told my bladder is like someone who is 90 years old. I have had surgery, but was told that may not be a permanent solution. Would stem cell therapy produce a more lasting, positive outcome?
Answer from Lander: Complex situations like this must be evaluated on a case by case basis. We have experience injecting urethral strictures with stem cells and we are hopeful that we will continue to see good results since SVF is capable of mitigating many types of scar tissue.