Installment 75 - Ask the Doctor with Dr Chris Centeno of the Centeno-Schultz Clinic

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Jeannine

Pioneer Founding member
About Dr Centeno

Dr Chris Centeno is a physician scientist whose work is in the area of interventional orthopedics-the development of technologies that allow the use of needle based procedures performed through sophisticated guidance techniques to replace the need for more invasive and traditional orthopedic surgery. Dr. Centeno performed the first advanced stem cell procedures in orthopedic patients in the United States in 2005/2006 and has published many of these results. To date his clinic has treated several thousand orthopedic patients with stem cell based therapies. He maintains an active medical practice and treats patients from all over the globe and the U.S. who are seeking alternatives to surgery. He is also involved in many active research projects in the areas of orthopedic stem cell biology, the development of novel devices, the clinical outcome of biologic therapies, and the methods used to treat spinal injury. His practice features a large state of the art clean room, clinical and research lab with several full time cell biologists on staff, an active lab based research program with a full time Ph.D. level research group, a bioengineering department, and a clinical research arm that runs a clinical registry and organizes clinical research. The research is supported by the generous contributions of a high net worth individual.

Centeno-Schultz Clinic
403 Summit Blvd., Suite 201
Broomfield, CO 80021

Visit: http://www.regenexx.com/
Phone: 1-888-525-3005



Q & A

Q: If you could transport yourself in a time machine and go 30 years into the future, how far will regenerative procedures go in curing neurological diseases and traumas such as TBI, CP, MS, ALS and Parkinsons? Please, if the answer can be in two different scenarios, one as an FDA regulated drug and the other regulated as a medical procedure so we can see two alternate universes.
A: I think that for many easier to treat diseases like tendon/ligament injuries, cheap biologics like platelet rich plasma and bone marrow concentrates will rule the day and be widely covered and the standard of care. For neurologic diseases, this is where for the most severe conditions, we’ll see advanced cellular therapies such as cultured and conditioned cells make a splash. In the 10 year horizon, there will be a competition between lower cost medical procedures using cells and more expensive cell drugs. Much of this will have to do with the fact that most cell drugs for neurologic diseases won’t have much better outcomes than medical procedures. In the 20 year horizon the second generation of cell drugs will improve upon the first and include many lab created concoctions such as induced pluripotent and artificially created cells which will be able to repair tissue better than cell based medical procedures, but also have steeper side effect profiles. By 30 years the side effect profiles of the 2nd generation cell drugs will have been mitigated by the third generation cell drugs, providing robust nervous system repair with less side effects. We’ll also be routinely printing many replacement parts for the nervous system. However, through this 30 year time line, cost will be a huge issue with many cell drugs failing because they can’t be manufactured and approved at low cost, causing availability issues for patients (i.e. many won’t gain widespread insurance coverage because of their high costs).

Q: Has stem cell therapy worked for osteoporosis? Has it worked for asthma? Can you help me find the perfect doctor for my wife? Would treating these two conditions have to be done separately if your answers are in the affirmative?
A: Using your own bone marrow stem cells to treat osteoporosis is feasible, but this won’t work for wide spread forms of the disease because the stem cells are involved in the cause of the problem (i.e. they fail to make enough cells that can produce bone). This is therefore an application where someone else’s cells (i.e. donor cells from a young person) are needed. I have yet to see a credible cell therapy for asthma. Most of the lung research on reactive airways disease and stem cells has been on COPD (emphysema).

Q: What stem cells could be used to repair nerve damage and denervated muscle damaged by injury? Specifically brachial plexus nerve damage affecting all three deltoids and scapula muscle?
A: This depends on the cause of the initial injury, it’s age, the amount of muscle atrophy, etc… We have had some success with using the growth factors taken from platelets to break up scar tissue around nerves that could be compressing or irritating the nerve. We’ve also seen some return of motor function by injecting directly into the nerve, but this was in a patient with a relatively new injury (about 1 year out), see http://www.regenexx.com/2012/11/can-we-regenerate-a-radial-nerve-with-a-regenexx-pl-nerve-hydrodissection-under-ultrasound-guidance/ . As far as stem cells are concerned, to work for nerve repair they need to be heavily pushed in the direction of becoming nerve cells in culture or count on their release of growth factors (such as nerve growth factor [NGF]) to help repair cells. There have been some encouraging results in early human studies of using just cultured mesenchymal stem cells for spinal cord injury, but I have yet to see any publications in brachial plexus injury.

Q: Is there any information on using IV injected Mannitol to make the blood brain barrier more permeable for delivery of stem cells? One treatment center in southern California is running trials using this method. I would consider this for my wife, but not until I get some positive feedback.
A: Very, very few stem cells cross the blood brain barrier when they are given IV, in one study just 0.0005% made it across.

However, the dichotomy between what’s being offered and this study brings up a very important point. The mouse study using mannitol places the cells into the carotid artery so that their next stop is the brain. The California therapy places them IV, which is vastly different. In the case of IV stem cells, almost all of them are sequestered in the lungs (see http://www.regenexx.com/2014/02/how-stem-cells-work-4/), so only 3% of the cells would ever make it to the brain that mannitol has now made more permeable. This also brings up a couple of other important points. First, this is a mouse study, so who knows if this works in humans. Most mouse research doesn’t translate well to humans. Second, and perhaps more importantly, the animal studies place the cells into the artery leading to the brain. So any clinic claiming to replicate the animal study would have to have an experienced interventional cardiologist who can place these cells into the carotid artery, which would mean an increase in risk and cost for the clinic. So a clinic claiming to be able to do this IV, means that the clinic isn’t at the sophistication level of one I would trust with my loved ones.

Q: Orthopedic use of stem cells seems to be in wide use in the U.S. What is the timeline for FDA approval of this application?
A: FDA approval for orthopedic stem cells can only happen if the cells are approved as drugs. There are a few FDA approved products on the horizon, but given their cost relative to the early results in knee arthritis and spine, while they might get FDA approval, they are unlikely to get insurance coverage. This is because these days, insurers are moving toward the lowest cost therapy to get the job done. So for knee arthritis, the lowest cost option is likely drugs or a knee replacement, given the high price a stem cell drug company must charge to defray the regulatory and manufacturing costs. In the meantime, we may see lower cost biologic treatments (that are FDA exempt) like platelet rich plasma or bone marrow concentrate (BMC) get insurance reimbursement long before more costly stem cell drugs. For tennis elbow, we’re likely only a few years away from insurance coverage for PRP. For knee arthritis, either PRP or BMC is about a 5-10 years away from insurance coverage for knee arthritis.

Q: Can peripheral neuropathy be treated with stem cells? If so, which type (marrow, uc, adipose) are the best and how would they be delivered? Are there any large animal studies done using stem cells for this, specifically equine studies? I am not interested in rodent studies. I have read that PN may have nutritional causes. Certain vitamins may help such as Vitamin E. I have noticed on your website that you often discuss supplementation. What recommendations might you have?
A: Stem cells could have an application in peripheral neuropathy (PN), this is a good review article: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3988365/pdf/fendo-05-00045.pdf . Most of the studies I found used small animals like rats. The delivery would likely be similar to that for peripheral artery disease, with direct injections under ultrasound guidance into the nerves or skin areas impacted. The single biggest cause of PN is diabetes or poor blood sugar control (i.e. metabolic syndrome). While B vitamins may help, I think I would get my HBA1C under control (this is a measure of blood sugar control that is a simple blood test) and below about 5.3 before I did anything else. This would be through a very strict low carb diet and exercise.

Q: I saw an interview with an assistant professor at Emory Sports Medicine Center in Atlanta. He is using stem cells for arthritic joints, but warned it could not replace the need for joint replacement surgery, only postpone it. In your practice, have you had any patients where stem cells failed and they had to resort to joint replacement? Is there any trend surfacing yet in the medical literature that indicates overall efficacy and durability of orthopedic stem cells?
A: The physician at Emory is a good doctor, but one who, as of yet, has very limited experience in the use of stem cells for joint pain. As far as stem cell injections replacing the need for joint replacements, we’ve published more on that topic (stem cell injections and arthritis) than any other author world-wide, see http://www.regenexx.com/2014/10/most-stem-cell-research-in-orthopedics/. In our recent 4 year dataset, we know of 7 of 35 patients expected to report (out of 999 total patients) at 4 years that needed a knee replacement somewhere along the way. See http://www.regenexx.com/2014/10/knee-arthritis-stem-cell-treatment-research/. Of note, the 10/35 patients who did report back to us on outcome reported high rates or relief (about 80-90% improvement). Since even an FDA trial would never follow patients for relief this long due to the practicalities of keeping someone in an experiment for years and years, this type of registry data is what all that we’ll have going forward. How do I interpret it? There are a subset of patients with knee arthritis who are still doing quite well at 4 years out and there’s a subset that needed a knee replacement despite the injections.

Here’s our long-term pain and functional data: http://www.regenexx.com/wp-content/uploads/2014/09/knee-arthritis-stem-cell-research-thumb.jpg
Here’s our recent research paper on more than 800 patients: http://www.regenexx.com/2014/09/we-publish-the-worlds-largest-paper-on-knee-arthritis-and-stem-cells/

Q: I've had CIDP (since 2011). It reached the axons in my hands and legs. I have banked my child's umbilical cord. Is there anyway that I can use it to regenerate the nerves and try to connect with muscles with no complications? I know there is only a limited amount of stem cells that could be extracted. Would it be better to take the stem cells from an adult? Are the injections better in the spinal cord or in central peripheral nerves in the head? Some clinics have told me they would use netrophin, neural stem cells from embryos. What do you think about this?
A: I have no direct experience with CIPD as we are only orthopedic focused. I don’t think that using your child’s umbilical stem cells is a viable idea, as regrettably this would be an unapproved drug. I would be cautious about using stem cells from embryos mostly because tissue sourcing in foreign countries is troublesome and you have no good way to ensure the tissue doesn’t have communicable diseases. In addition, embryonic stem cells are the only stem cell type that have had an issue with tumors (which is quite different from adult stem cells).

Q: The Cleveland Clinic just announced their 2 year trial treating MS with their own expanded stem cells and established the treatment was safe. The subsequent phase 2-4 trials and FDA approval process will take 8-10 years before this reaches patients. If this was Japan, MS patients could begin using the therapy covered by insurance, while outcomes are tracked over 7 years to establish efficacy. What is it going to take for the U.S. to adopt a similar approach to regenerative medicine?
A: The financial incentives and powers in the US would never let this happen. The issue is that there are many business interests that would oppose this type of fast track approval process. The FDA itself funds two thirds of its drug approval budget through fees paid by industry for drug approval. The pharma companies also would never let a cell therapy through the system they didn’t control, as unless they can take big profits out of stem cells to replace lost profits from MS drugs, this is a net loss to their shareholders. Finally, universities these days are more business interests in this arena and they would lose both pharma licensing monies as well as clinical trials income.

Q: I have seen clinics other than the main one you have in Broomfield that say they offer the Regenexx procedures. Do you own these clinics or do the doctors go through some kind of extensive training and then get licensed to use the Regenexx procedure? I guess what I am getting at is if I decide to have stem cell treatment for my crappy knees, should I come to Colorado or can I be assured to get the same type of experienced doctors treating me at other clinics using this method as I would from you in Colorado? I do not live that close, but would not compromise the best if need be.
A: We do have a network of providers that we have trained and that have small labs in their office for the same day processing of platelets and bone marrow stem cells. They use our processing procedures and get the continual updates that we offer through our lab and clinical research programs. They are an exclusive group, as unlike all other stem cell networks, we turn down more than 90% of the interested physicians, see http://www.regenexx.com/2014/08/our-network-providers-are-highly-trained/ . They are continuously supported and trained, again unlike other networks. I have full confidence in their abilities.
 
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