Ask the Doctor with Dr Centeno, ICMS Founder
Dr. Centeno is an international expert and specialist in musculoskeletal, spinal, and neurological injury. He is an M.D. who is double boarded in both Physical Medicine and Rehabilitation as well Pain Medicine.
Dr Centeno is the founder of the International Cellular Medicine Society (ICMS). For more information about Dr Centeno and his work visit http://www.cellmedicinesociety.org
Dr Centeno trained at the Baylor College of Medicine, Texas Medical Center, and the Institute for Rehabilitation Research. He is medical director of The Centeno-Schultz Clinic and the Spinal Injury Foundation. He also serves as Medical Director for Regenerative Sciences, Inc. http://www.regenexx.com and director of RSI?s lab. He is the author of the medical text, The Spine Dictionary and practices in Denver, North Denver, and Boulder, Colorado.
Q&A
Q: I spoke to the founders of LetsCureCP.org, and I made them aware of the FDA's absurdity towards autologous stem cell therapies. Their organization has embarked on creating a medical device that is capable of extracting stem cells from patients on the same day and processing them in the same room. They say that such a device would circumvent FDA regulations on autologous stem cell therapies since the FDA does not allow bone marrow or blood to be processed outside of the same room and for an extended period of time. Are you aware of this, and if it is true, can this type of device possibly foster more treatments in the U.S.?
A: First, the FDA doesn’t control or regulate any aspect of a medical procedure, but they seem to have forgotten that point. Having said that, the group refers to the 21 C.F.R. 1271.15(b) same surgical procedure exemption. Regrettably this is being very narrowly defined by the agency at the moment. The bedside processing of marrow cells is allowed under this exemption, as long as the machine only centrifuges cells in few steps. There are multiple machines on the market that do this, but they produce only the fraction of the marrow with stem cells, not stem cells. However, other machines processing fat have not been granted this exemption, as more steps are required and the cells are usually used in a non-homologous fashion (not the way they are used in the body). In summary, I doubt any machine that the group could come up with would be granted a 510K clearance under this exemption if it did anything more than the simple marrow based centrifuges already on the market. If it didn’t do anything more than those existing machines, then there’s no reason to create a new machine.
Q: Considering your prediction may be a rough estimate, I would understand if you would be off by a few years. In how many years do you predict stem cell therapy reaching a point to regenerate cells to repair vital organs and replace organ transplants?
A: 10-15 years
Q: In the news lately was a story of Don Elliman, the new executive director of the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology in Colorado. He was tapped for the job by the daughter of the late Mr. Gates, Diane Wallach. She was quoted as saying, "They've got great intellectual minds out there. What they don't have in academia, and this is a common situation, is the business sense. You need collaboration to get the therapies moving through the system quickly and get them to the patients. There isn't a lot of experience with this in that environment." What I hear her saying is that research is to blame for the snail's pace in this country as far as actual available stem cell treatment for patients. Is the FDA's stance on calling our own stem cells drugs strictly research related then? Are they moving slowly because academia is moving too slowly?
A: This is a very complex question with a complex answer. First, research is a business. The universities compete for federal and other grants to fund research. We all pay for this system in tax dollars and I like to describe it as a slot machine. We put our coins from taxes up at the top in hopes of a big cure pay off. In the case of stem cells, INHO we have had excessive basic science research because the money has been there in droves to pay for the research. Now you might think that the average researcher won’t be given a new grant until he shows progress toward curing a real disease, but that’s not the case. In fact, getting to a cure for a real disease is often not considered in the complex equation of whether he gets more money from the government. As far as stem cells are concerned, we have placed far too many coins in the machine with far too little pay off. So the fact that this new director is talking about trying to commercialize things is good, because at least that moves the money spent away from basic science and more toward real cures.
Q: Is it legal to add growth factors in the U.S. or just what is considered illegal? It seems adding growth factors is almost some kind of manipulation. Where is the line drawn? What does manipulation really mean?
A: Again, what a physician does to treat his or her patients is not in any way shape or form controlled or regulated by the FDA, but again the FDA seems to need some help in realizing that lately. Hopefully we can clarify that issue for everyone concerned. They have defined a line in the sand approach called “minimal manipulation” and you can either be “less than” or “more than”. If you’re not over this line the cells are considered body parts, if you are over this line the cells are considered drugs. The line is supposed be drawn based on a few parameters, the biggest being whether what you do to the cells changes their biologic characteristics. The issue is that the agency seems to interpret this line more and more narrowly every day. For example, in the late 1990’s through the early 2000’s, most experts would have said that simple culturing of cells did not cross this line, as you were not doing anything to change the cell’s characteristics, just growing more. Today, the FDA says this crosses the line. As another example, simply using fat based stem cells and processing them at the bedside would seem to stay on the body part side of this line, but FDA has recently announced this crosses the line and makes these fat cells drugs.
Q: Why is it illegal to transport stem cells over state lines? I read that this was not the FDA that has this regulation. Why would another agency be involved in this type of regulation?
A:I think there’s some confusion. What a doctor does with your stem cells as part of his or her medical practice is covered through the practice of medicine and regulated in the state where that doctor practices by that state’s medical board. The agency again seems to need some reminding of the century old distinction. This includes medications, stem cells, or whatever else the doctor does. For example, a doctor can have any substance (FDA approved or not), compounded by the local pharmacy all under the practice of medicine. However, if stem cells are made by a lab and transported across state lines, that invokes the “interstate commerce” clause and that means the FDA does regulate those cells using the distinctions I discussed above.
Q: What can "we the people" do to help or stop the FDA from keeping life saving treatments from us?
A: Comment on the federal register notice (http://www.stemcellpioneers.com/showthread.php?t=4571). The FDA is required by law to explain why it agrees or disagrees with those comments and I can tell you they have no good rationale on why they control a doctor using your stem cells to treat your disease. So commenting there will at least create some interesting issues for the agency as it tries to connect the regulatory dots that just don’t connect (INHO). Next, get behind ICMS, who is trying to place some sanity and safety in the stem cell treatment clinics that do exist. Refuse to be treated by clinics that refuse to be accredited by ICMS. After all, an accredited clinic has to: make sure it’s treatments are reviewed for safety by its peers, track every patient ever treated (not just the rock star patients that do well) and at some point report that data, and treat according to common sense clinical guidelines (like giving you an honest assessment of your candidacy for their procedure (Good, Fair, Poor) and not pretend to treat every condition known to man). There are enough clinics out there now for patients to start demanding a minimum level of safety and sanity. More accredited clinics means more horsepower for physicians and patients to assert their basic rights.
Q: Does a prp procedure require FDA approval? Can doctors legally remove blood and put it back into patients under their own medical licenses? Why would the FDA involve itself in these issues and not have restrictions on blood transfusions? Does a doctor who performs stem cell therapies or prps need special licensing or approvals for processing or having a laboratory? I just don't see how the FDA seems to pick and choose what they regulate. A: See above. If the doctor “activates” PRP at the bedside (which just about every clinic does), it’s technically crossing that “minimal manipulation” line that FDA has asserted. There are many things that cross this line (including most IVF procedures for infertility, which now culture cells). The FDA has not consistently applied this line at this point.
Q: I'm confused as I am only just seeing U.S. stem cell clinics advertising themselves as "legal". I'm hoping to have my little girl with CP go to the U.S. for therapy in the imminent future and wanted to understand if these clinics are:
a) New?
Many are new and have never done cell therapies before.
b) Have always been there but I never knew?
See above.
c) Have recently found a loophole in the U.S. law or around the ridiculous FDA regs that are bugging all U.S. citizens that want more access to decent stem cell therapy?
A: No, many are operating on bad regulatory advice regarding the use of fat stem cells. The FDA recently made it very clear on their website that they consider the use of fat based stem cells for a non-homologous use (which is certainly CP, COPD, orthopedics and just about everything else) to be a drug. As a result, some of these clinics will fly below the radar and some of the more high profile ones will likely be getting a visit from their friendly neighborhood FDA agents very soon. The proliferation of these clinics is based on companies selling kits to process fat cells at the bedside. We have serious safety concerns about using these kits, see http://www.regenexx.com/2011/03/shaker-kits-and-stem-cells-in-a-grocery-bag/ If it were my child I would require that the clinic be accredited by ICMS and that the clinic take reasonable safety steps such as processing cells in a hood.
Q: What is the actual legal/regulatory situation for these clinics using autologous stem cell therapy in the U.S.? Are they at risk of suddenly shutting down like what happened in Germany at X-Cell?
A: See above. In my opinion, what they are doing is not FDA regulated, but regulated by their state medical boards. Having said that, the agency looks at it differently and all are at risk for being shut down like X-Cell.
Q: When does the case against your company go to trial? I am totally disgusted that as a taxpayer I have to spend money fighting you in court. I hope you win big time. At least then, it will be money well spent.
A: We sued FDA four times, they sued us once and then we counter sued. Regrettably, because of a doctrine called “ripeness” we desperately needed them to sue us, as only then could we question their regulations. It may sound silly, but if DOT shows up tomorrow and wants to blow up your house to make way for a new highway, you generally have no right to question their authority to blow up the house until after the house is scheduled to be blown up (the doctrine of ripeness saying that until the govt. agency decides what to do or does it, you can’t question them). So since we needed them to stop playing “hide the ball” and telling us for two years that they had no idea of what they were going to do, your tax money is at least being spent so that we can question their authority.
Q: If a patient has a terminal disease and there is no drug or surgery that can help them, then how can the FDA not allow them to try stem cell therapy? How did this agency get so much power and control that is causing needless deaths and suffering? Are mainstream doctors afraid to speak up? Is it just the visionary doctors that are putting themselves out there for patients who have no other options? Politicians seem to be in the dark as well. The U.S. is supposed to be the model of freedom and yet there is no freedom when the FDA puts a noose around your neck.
A: For an explanation from someone other than myself, see http://www.burzynskimovie.com/. The movie will knock your socks off.
Dr. Centeno is an international expert and specialist in musculoskeletal, spinal, and neurological injury. He is an M.D. who is double boarded in both Physical Medicine and Rehabilitation as well Pain Medicine.
Dr Centeno is the founder of the International Cellular Medicine Society (ICMS). For more information about Dr Centeno and his work visit http://www.cellmedicinesociety.org
Dr Centeno trained at the Baylor College of Medicine, Texas Medical Center, and the Institute for Rehabilitation Research. He is medical director of The Centeno-Schultz Clinic and the Spinal Injury Foundation. He also serves as Medical Director for Regenerative Sciences, Inc. http://www.regenexx.com and director of RSI?s lab. He is the author of the medical text, The Spine Dictionary and practices in Denver, North Denver, and Boulder, Colorado.
Q&A
Q: I spoke to the founders of LetsCureCP.org, and I made them aware of the FDA's absurdity towards autologous stem cell therapies. Their organization has embarked on creating a medical device that is capable of extracting stem cells from patients on the same day and processing them in the same room. They say that such a device would circumvent FDA regulations on autologous stem cell therapies since the FDA does not allow bone marrow or blood to be processed outside of the same room and for an extended period of time. Are you aware of this, and if it is true, can this type of device possibly foster more treatments in the U.S.?
A: First, the FDA doesn’t control or regulate any aspect of a medical procedure, but they seem to have forgotten that point. Having said that, the group refers to the 21 C.F.R. 1271.15(b) same surgical procedure exemption. Regrettably this is being very narrowly defined by the agency at the moment. The bedside processing of marrow cells is allowed under this exemption, as long as the machine only centrifuges cells in few steps. There are multiple machines on the market that do this, but they produce only the fraction of the marrow with stem cells, not stem cells. However, other machines processing fat have not been granted this exemption, as more steps are required and the cells are usually used in a non-homologous fashion (not the way they are used in the body). In summary, I doubt any machine that the group could come up with would be granted a 510K clearance under this exemption if it did anything more than the simple marrow based centrifuges already on the market. If it didn’t do anything more than those existing machines, then there’s no reason to create a new machine.
Q: Considering your prediction may be a rough estimate, I would understand if you would be off by a few years. In how many years do you predict stem cell therapy reaching a point to regenerate cells to repair vital organs and replace organ transplants?
A: 10-15 years
Q: In the news lately was a story of Don Elliman, the new executive director of the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology in Colorado. He was tapped for the job by the daughter of the late Mr. Gates, Diane Wallach. She was quoted as saying, "They've got great intellectual minds out there. What they don't have in academia, and this is a common situation, is the business sense. You need collaboration to get the therapies moving through the system quickly and get them to the patients. There isn't a lot of experience with this in that environment." What I hear her saying is that research is to blame for the snail's pace in this country as far as actual available stem cell treatment for patients. Is the FDA's stance on calling our own stem cells drugs strictly research related then? Are they moving slowly because academia is moving too slowly?
A: This is a very complex question with a complex answer. First, research is a business. The universities compete for federal and other grants to fund research. We all pay for this system in tax dollars and I like to describe it as a slot machine. We put our coins from taxes up at the top in hopes of a big cure pay off. In the case of stem cells, INHO we have had excessive basic science research because the money has been there in droves to pay for the research. Now you might think that the average researcher won’t be given a new grant until he shows progress toward curing a real disease, but that’s not the case. In fact, getting to a cure for a real disease is often not considered in the complex equation of whether he gets more money from the government. As far as stem cells are concerned, we have placed far too many coins in the machine with far too little pay off. So the fact that this new director is talking about trying to commercialize things is good, because at least that moves the money spent away from basic science and more toward real cures.
Q: Is it legal to add growth factors in the U.S. or just what is considered illegal? It seems adding growth factors is almost some kind of manipulation. Where is the line drawn? What does manipulation really mean?
A: Again, what a physician does to treat his or her patients is not in any way shape or form controlled or regulated by the FDA, but again the FDA seems to need some help in realizing that lately. Hopefully we can clarify that issue for everyone concerned. They have defined a line in the sand approach called “minimal manipulation” and you can either be “less than” or “more than”. If you’re not over this line the cells are considered body parts, if you are over this line the cells are considered drugs. The line is supposed be drawn based on a few parameters, the biggest being whether what you do to the cells changes their biologic characteristics. The issue is that the agency seems to interpret this line more and more narrowly every day. For example, in the late 1990’s through the early 2000’s, most experts would have said that simple culturing of cells did not cross this line, as you were not doing anything to change the cell’s characteristics, just growing more. Today, the FDA says this crosses the line. As another example, simply using fat based stem cells and processing them at the bedside would seem to stay on the body part side of this line, but FDA has recently announced this crosses the line and makes these fat cells drugs.
Q: Why is it illegal to transport stem cells over state lines? I read that this was not the FDA that has this regulation. Why would another agency be involved in this type of regulation?
A:I think there’s some confusion. What a doctor does with your stem cells as part of his or her medical practice is covered through the practice of medicine and regulated in the state where that doctor practices by that state’s medical board. The agency again seems to need some reminding of the century old distinction. This includes medications, stem cells, or whatever else the doctor does. For example, a doctor can have any substance (FDA approved or not), compounded by the local pharmacy all under the practice of medicine. However, if stem cells are made by a lab and transported across state lines, that invokes the “interstate commerce” clause and that means the FDA does regulate those cells using the distinctions I discussed above.
Q: What can "we the people" do to help or stop the FDA from keeping life saving treatments from us?
A: Comment on the federal register notice (http://www.stemcellpioneers.com/showthread.php?t=4571). The FDA is required by law to explain why it agrees or disagrees with those comments and I can tell you they have no good rationale on why they control a doctor using your stem cells to treat your disease. So commenting there will at least create some interesting issues for the agency as it tries to connect the regulatory dots that just don’t connect (INHO). Next, get behind ICMS, who is trying to place some sanity and safety in the stem cell treatment clinics that do exist. Refuse to be treated by clinics that refuse to be accredited by ICMS. After all, an accredited clinic has to: make sure it’s treatments are reviewed for safety by its peers, track every patient ever treated (not just the rock star patients that do well) and at some point report that data, and treat according to common sense clinical guidelines (like giving you an honest assessment of your candidacy for their procedure (Good, Fair, Poor) and not pretend to treat every condition known to man). There are enough clinics out there now for patients to start demanding a minimum level of safety and sanity. More accredited clinics means more horsepower for physicians and patients to assert their basic rights.
Q: Does a prp procedure require FDA approval? Can doctors legally remove blood and put it back into patients under their own medical licenses? Why would the FDA involve itself in these issues and not have restrictions on blood transfusions? Does a doctor who performs stem cell therapies or prps need special licensing or approvals for processing or having a laboratory? I just don't see how the FDA seems to pick and choose what they regulate. A: See above. If the doctor “activates” PRP at the bedside (which just about every clinic does), it’s technically crossing that “minimal manipulation” line that FDA has asserted. There are many things that cross this line (including most IVF procedures for infertility, which now culture cells). The FDA has not consistently applied this line at this point.
Q: I'm confused as I am only just seeing U.S. stem cell clinics advertising themselves as "legal". I'm hoping to have my little girl with CP go to the U.S. for therapy in the imminent future and wanted to understand if these clinics are:
a) New?
Many are new and have never done cell therapies before.
b) Have always been there but I never knew?
See above.
c) Have recently found a loophole in the U.S. law or around the ridiculous FDA regs that are bugging all U.S. citizens that want more access to decent stem cell therapy?
A: No, many are operating on bad regulatory advice regarding the use of fat stem cells. The FDA recently made it very clear on their website that they consider the use of fat based stem cells for a non-homologous use (which is certainly CP, COPD, orthopedics and just about everything else) to be a drug. As a result, some of these clinics will fly below the radar and some of the more high profile ones will likely be getting a visit from their friendly neighborhood FDA agents very soon. The proliferation of these clinics is based on companies selling kits to process fat cells at the bedside. We have serious safety concerns about using these kits, see http://www.regenexx.com/2011/03/shaker-kits-and-stem-cells-in-a-grocery-bag/ If it were my child I would require that the clinic be accredited by ICMS and that the clinic take reasonable safety steps such as processing cells in a hood.
Q: What is the actual legal/regulatory situation for these clinics using autologous stem cell therapy in the U.S.? Are they at risk of suddenly shutting down like what happened in Germany at X-Cell?
A: See above. In my opinion, what they are doing is not FDA regulated, but regulated by their state medical boards. Having said that, the agency looks at it differently and all are at risk for being shut down like X-Cell.
Q: When does the case against your company go to trial? I am totally disgusted that as a taxpayer I have to spend money fighting you in court. I hope you win big time. At least then, it will be money well spent.
A: We sued FDA four times, they sued us once and then we counter sued. Regrettably, because of a doctrine called “ripeness” we desperately needed them to sue us, as only then could we question their regulations. It may sound silly, but if DOT shows up tomorrow and wants to blow up your house to make way for a new highway, you generally have no right to question their authority to blow up the house until after the house is scheduled to be blown up (the doctrine of ripeness saying that until the govt. agency decides what to do or does it, you can’t question them). So since we needed them to stop playing “hide the ball” and telling us for two years that they had no idea of what they were going to do, your tax money is at least being spent so that we can question their authority.
Q: If a patient has a terminal disease and there is no drug or surgery that can help them, then how can the FDA not allow them to try stem cell therapy? How did this agency get so much power and control that is causing needless deaths and suffering? Are mainstream doctors afraid to speak up? Is it just the visionary doctors that are putting themselves out there for patients who have no other options? Politicians seem to be in the dark as well. The U.S. is supposed to be the model of freedom and yet there is no freedom when the FDA puts a noose around your neck.
A: For an explanation from someone other than myself, see http://www.burzynskimovie.com/. The movie will knock your socks off.
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