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Thread: Installment 86 - Ask the Doctor by Riordan-Mckenna Institute

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    Default Installment 86 - Ask the Doctor by Riordan-Mckenna Institute

    About Riordan-McKenna Institute

    Board certified in orthopedic surgery, Dr. Wade McKenna is the chief medical officer and co-founder of Riordan-McKenna Institute. He has performed over 20,000 surgeries and is a co-founder of Biologic Therapies, a product development and research company dedicated to the advancement of autologous adult stem cell therapy. He patented the BioMacô bone marrow aspiration catheter, an improved method of harvesting bone marrow, now becoming the standard for extraction.

    Neil Riordan, PhD is the Co-Founder and Chief Science Officer of the Riordan-McKenna Institute. Dr. Riordan is one of the early pioneers and leading experts in cell therapy. Dr. Riordan is an accomplished inventor and scientist. He has published over 60 scientific articles in international peer-reviewed journals, authored 3 book chapter on stem cells, and has given more than 100 lectures on stem cells nationally and internationally. He is also the Founder and Chairman of Medistem Panama, Inc., (MPI) a leading stem cell laboratory and research facility located in the Technology Park at the prestigious City of Knowledge in Panama City, Panama as well as the Stem Cell Institute (SCI) in Panama City, Panama.

    RMI combines biologic cellular therapies with state-of-the art orthopedic options to postpone or eliminate the need for surgery, or augment a necessary surgery for faster healing.
    Riordan-McKenna Institute
    801 E. Southlake Blvd.
    Southlake, TX 76092
    http://www.rmiclinic.com/


    Q & A

    Q: Why do some doctors swear by adipose treatments and some by bone marrow? Iím totally confused by which is best. Does it depend on the treatment needed, age of patient, doctor preference, or what?
    A: (Dr Riordan) Because our focus at Riordan-McKenna Institute is orthopedics, I will answer mostly in that context.
    The advantage in orthopedics for using bone marrow aspirate concentrate (BMAC) vs. adipose is that like adipose, BMAC contains mesenchymal stem cells (MSCs) that can stimulate wound healing, reduce inflammation, and modulate immune cells, but unlike adipose, it also contains significant numbers of other cell types that can induce new blood vessel growth and reinvigorate tissue that doesnít have adequate blood supply. The bone marrow cells include cells that can induce angiogenesis; new blood vessel formation. Without new blood vessel formation, no tissue heals properly or completely.
    That being said, in my experience, adipose-derived cells can be somewhat useful for certain immune conditions like MS and rheumatoid arthritis but umbilical cord tissue-derived MSCs, which are not available in the US, are a better option.

    Q: So, the type of stem cells and other biologics used certainly does depend on the condition treated. Age, especially when using a patientís own stem cells, which decrease in number and potency as they age, is another important factor. Of course, doctor preference always comes into play.
    A: (Dr. McKenna) Bone marrow, especially augmented with AlphaGEMS amniotic tissue product, does a better job than fat alone.
    The angiogenic potential in fat is compromised by the lack of CD34 positive cells. CD34+ cells are the stem cells that form the other cells found in the blood and are crucial to micro-angiogenesis (new blood vessel growth) and the healing of cartilage, tendons, and soft tissues . All that begins and ends with micro blood vessels and angiogenesis.
    Even the chondrogenic (cartilage-forming) potential from a fat stem cell is different from bone marrow stem cells. There are several hundred known components that make of a cellís secretome (secreted molecules in free form and inside of particles known as exosomes and microvesicles). The secretome of a bone marrow MSC is different than a fat MSCís secretome. For example, the bone marrow MSCs secrete molecules that are crucial for making new cartilage.
    The only real advantage to fat is relatively higher MSC counts than bone marrow. Significant cell counts can be obtained with large liposuctions. However, in orthopedics, these large numbers of cells only work best in fat grafting, which also requires PRP. Overall, for orthopedics, BMAC augmented with AlphaGEMS is the way to go in my opinion.
    Regardless of whether fat-derived stromal vascular fraction is a viable option for orthopedic conditions, it is currently illegal to use it in the US in any way that makes sense.
    The use of enzymatic digestion, washing of the tissue and concentration of the cellular volume from fat, is illegal because the FDA considers enzimatic digestion a violation of its current and newly proposed guidelines. Therefore, in our clinic setting, we avoid using fat for any reason in order to avoid confrontation with the FDA, which has recently started to crack down on clinics treating patients with adipose products.
    It is a bit ironic that we donít use fat at our US clinic since Dr. Riordan developed the first stromal vascular fraction treatments in the world and also pioneered the use of MSCs cultured from fat for the treatment of autoimmune conditions nearly a decade ago, including the first in human safety paper using stromal vascular fraction from fat in patients with rheumatoid arthritis with Indiana University.



    Q: Considering the risks of invasive surgery, how long do you think it will take for the insurance industry starts to recognize that stem cell treatment for orthopedic conditions is safer and should be an option for patients?
    A: (Dr. Riordan) I think itís still a few years out. There are new studies being published all the time. In particular, there is a series coming out of France from Dr. Hernigou, one that showed the results of rotator cuff repair with and without bone marrow stem cells. If an insurance company does the math on this I think they, from a business perspective, pay for the bone marrow procedure because the outcomes are so much better and they will then not have to pay for a second or third surgery, which can run twenty thousand dollars and up.

    A: (Dr. McKenna) As an orthopedic surgeon, my offices work closely with insurers some are starting to come around, albeit at a snailís pace.
    Texas workers compensation coverage of tennis elbow is a great example of the benefits/cost ratio in orthopedics. When tennis elbow patients donít respond to physical therapy and anti-inflammatories and cannot return to work, subsequent surgery doesnít always guarantee a favorable outcome and rapid return to work either. In fact, it can take months to return to work after surgery.
    Data out of Italy on partial thickness tears treated with PRP showed that injecting biologics significantly decreased the amount of time it took for a patient to return to work without limitation. This data lead the state of Texas and workers comp insurance, which both recognized the extensive recovery time for surgery, to require that patients with lateral epicondylitis (tennis elbow) receive PRP injections before surgery could be approved. So in this case, biologics are now covered by insurance. This represents a significant milestone to have a surgical procedure come only after a biologics treatment has failed.
    Additional candidates for insurance coverage in the near future could be partial thickness tears in the rotator cuff and chronic hamstring tendonitis. These kinds of problems also respond well to biologics and the surgeries for them donít have a very quick recovery. Hopefully, the cost-savings will be recognized in a variety of ways like decreased recovery time, less time off work, shorter and less costly hospitalizations and decreased complications.
    A great combination of biologics with surgery to lower the costs and change the outcomes are the studies published by Dr. Hernigou.
    A series of 44 rotator cuff surgeries were performed with bone marrow aspirate, and 44 done without. He found that only 67% of the cuffs done with traditional surgery were still intact at 6 months, which is similar to the US failure rate of 30%.
    At 6 months, the patients treated with surgery and bone marrow aspirate were 100% successful. At 10 years, 44% of the cuffs treated without stem cells were intact, but a whopping 87% of those treated with stem cells were still intact. Furthermore, the 87% cohort who had surgery with bone marrow aspirate showed rotator cuff tissue nearly twice as thick as the 44% cohort who had surgery alone.
    So, when you look at secondary surgeries, the need for repeat surgical intervention, I think itís pretty easy to see the significant cost savings stem cell therapy can provide under the right circumstances.

    Q: What is your position on the proposed REGROW legislation? Do you find working in Texas has any benefits vs. other states? Are there any patients treated outside the US for more complicated conditions?
    A: (Dr Riordan) My position on this legislation is that it has great sentiment. The bi-partisan committee who put it together should be congratulated on attempting to change the FDAís position. I should also acknowledge all the academics that got involved including Dr. Arnold Caplan, who I consider a mentor, and the godfather of the MSC, and Les Miller from University of South Florida.
    Its intent is wonderful, but after discussing it with my FDA counsel, I donít think it has any hope of passing. It is an attempt to emulate the Japanese law from November 2015 that allows a company to market a stem cell product, which has already been deemed safe, for seven years while keeping a patient registry to document its success rate.
    The Regrow Act is very similar with the exception of it having a 5-year period instead of 7. I do not believe this bill stands a good chance of making it through the Senate as it has already been kicked back for changes.
    I believe there are better mechanisms by which to measure the use of adult stem cells, autologous and post-natal cells. These might be more expeditious in getting these stem cells into the hands of doctors and patients.
    There is some work being done on the congressional side that could reclassify the definition of Ďminimal manipulationí so that certain cell products that are currently illegal in the FDAís eyes currently could be implemented.

    Q: What kind of filtering system do you use in the processing of your stem cells? Are most of your treatments one-day treatments?
    A: (Dr. Riordan on filtering) We use a concentrating system that does have a filter on it. The systemís main function is to remove certain components of the bone marrow and concentrate it into an amount small enough to inject into a joint.
    Most of the treatments are one-day treatments.
    A: (Dr. McKenna on same-day procedures) All of our treatments using BMAC are same-day. It is injected the same day it is harvested and processed.
    Our goal is to use BMAC and AlphaGEMS (human amniotic membrane product) to turn big surgeries into small surgeries and small surgeries into a simple injection.
    In-office injections of BMAC and AlphaGEMS are commonly used for conditions like osteoarthritic joints; inflammatory disorders of the joints; partial and full thickness tears; and chronic, painful, partial tearing.
    For other issues, minimally invasive surgery augmented with BMAC and AlphaGEMS may be indicated.
    Complete medical history, MRI imaging, physical examination and patient preference all play a role in whether I recommend injections only or minimally invasive surgery augmented with biologics.
    Itís important to understand that not all orthopedic problems will respond to just a same-day injection of BMAC (with or without AlphaGEMS). It takes an experienced orthopedic surgeon to know when an injection is likely to work and when surgery augmented with biologics is a better option. This is not something that a plastic surgeon, anesthesiologist or pain management specialist is qualified to do.

    Q: There seems to be a lot of controversy about amniotic stem cell injections as to whether they even contain any live cells.
    A: (Dr. Riordan)The amnion tissue used to make our products does not need to contain any live cells for benefit and weíve never made that claim.
    The cells on the left have the morphology of young, healthy MSCs. No flattening, a red color of mitochondria, and theyíre spread throughout the whole cell body. On the right, youíll notice in cells that were not cultured with amnion, the cells are flat, fibroblastic looking. They are becoming senescent, the last step before they stop producing growth signals and can do nothing but basically form scar tissue.

    Click here to view pictures of cells with and without AlphaGEMS

    Not to avoid the question of live cells, yes or no, but rather to obviate it. It does not matter if there are live cells in the samples we use because they contain large quantities of molecules known to decrease inflammation, stimulate new blood vessel growth, and stimulate regeneration.

    As witnessed in these photographs you can see the difference between stem cells treated with AlphaGEMS and those without.

    Q: I love hearing accounts from famous sports figures about their stem cell treatments, why do you think their accounts rile so many naysayers in the industry? What do they fear? If stem cell treatments are working then why are so many people trying to stop doctors from administering them?
    A: (Dr. Riordan) - I think it comes down to conflicts of interest with the naysayers. The biggest opposition Iíve seen comes from two groups, one out of Japan and one global, both of which focus on embryonic stem cells or IPS cells. For both of those, theyíre potent intellectual property rights held by corporations that have a highly vested interest in seeing those technologies accelerated and used in therapy.
    My colleagues and I wrote a paper about the final nail in the coffin of embryonic stem cells entitled, ďThe King is Dead, Long Live the King: Entering A New Era of Stem Cell Research and Clinical DevelopmentĒ.
    Thereís an awful lot of money on the other side of the table. The anti-rheumatic aspect of the drug industry in the states is worth about 14 billion dollars a year. In a recent study treating rheumatoid arthritis with umbilical cord MSCs, the immune molecules those Big Pharma drugs target were greatly reduced with just one infusion of MSCs.
    For those on the other side who have nearly unlimited resources, I think the last thing they want is for something inexpensive and easy to administer to come along to replace their 14 billion dollars in revenues.
    Iím not sure itís a conspiracy but itís definitely a conflict of interest. The FDA is predominately funded through payments from pharmaceutical companies that are run by former FDA employees. It seems to be a vicious cycle of influence.

    A: (Dr. McKenna) Even traditional doctors give more pushback against stem cell therapy than I expected regarding the treatment of athletes and overuse injuries.
    Itís common to do things differently than the way we did them 20 years ago. Smart phones are a good example. However, surgeons and physicians amaze me by insisting on doing things the way they were done 20 years ago. In fact, the vast majority of orthopedic surgeons are not onboard with using stem cells to augment or replace surgery.
    Thereís been obvious advances in the field of science, electronics, and in medicine with the use of biologics with which we can actually lower infection rates and shorten time off work by completing the healing process in less than half the time compared to traditional surgery.
    Resistance is primarily based on insurance companies not paying for it. Many doctors donít spend the time to learn the science and are not willing to advance beyond that which they were taught as a resident, which is an incredible disservice to the patient. Itís important to stay up-to-date and not just give professional athletes access to this technology. My motherís rotator cuff tear isnít less or more of an injury than an athleteís tear. Everyone deserves it.

    Q: PRP vs. Stem Cell Therapy: when is PRP appropriate, when is it not?
    A: (Dr McKenna) Itís really important to point out that PRP, which contains growth factors spun down from whole blood, is not a stem cell product and may contain at best a few CD34+ cells. Therefore, PRP should never be advertised as a stem cell product.
    Because bone marrow consists of greater than 90% whole blood, there is nothing in PRP that isnít in the bone marrow in greater quantities. The biggest distinction is that bone marrow contains mesenchymal stem cells and other types of stem cells. PRP does not.
    PRP has been shown to speed up repair, but bone marrow aspirate does it faster and with a lower infection rate because it contains mesenchymal stem cells and the antimicrobial peptide LL-37 (along with many other factors), which is cytoprotective (protects cells).
    Basically, anything that PRP does, BMAC does better, but PRP can be used as a cheaper stopgap alternative for inflammatory problems. However, if economics were not a concern, then BMAC with AlphaGEMs would be my first choice.

    Q: Do you treat carpel tunnel syndrome, and if so, how?
    ADr. McKenna) Yes, we treat carpal tunnel syndrome. However, the recommended treatment protocol is dependent upon complete physical examination and a detailed medical history.
    Most carpel tunnel symptoms can be treated with just a brace, stretches, and anti-inflammatories. For elderly or diabetic patients, quick surgical intervention before the condition worsens is usually better.
    If people are noticing weakness or need two hands to do simple tasks, then a minimally invasive surgical procedure can make a difference very quickly. It should be done expeditiously to avoid further damage. Injecting BMAC and AlphaGEMS at the time of closure helps to accelerate tissue healing and assist nerve repair.

    Q: What makes the Bio-MAC bone marrow aspiration catheter superior to other methods of extraction?
    A: For more information about the advantages of using the Bio-MAC catheter, please visit: http://www.rmiclinic.com/news/a-new-standard-in-bone-marrow-harvesting-for-stem-cell-therapy-in-orthopedics-bio-mac-at-riordan-mckenna-institute/
    Last edited by Jeannine; 06-07-2016 at 09:34 AM.
    Still Pioneering
    Had UC treatment April 5th, 2007
    Had autologous treatment March 19, 2010
    Had bone marrow and adipose stem cell treatment (autologous) June 16, 2010

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