You never know who you might run into at Riordan Medical Institute in Southlake, Texas (Dallas-Fort Worth area). We wish you the best of luck on your UFC title defense Kamaru!
PBS TV (KERA 13) in Dallas-Fort Worth – Go inside our clinic and lab in Panama, and watch interviews with 3 patients. The other episode follows a knee patient through the treatment process at Dr. RIordan’s orthopedic stem cell clinic in Southlake, Texas. Sunday, January 29th from 12pm – 1pm.
Stem Cells I
Riordan-McKenna Institute – Stem Cell Therapy for Orthopedics
Take a journey with marathon runner and knee patient Jim Morella as he undergoes a stem cell augmented arthroscopic knee procedure. Peer inside the operating room as Dr. McKenna harvests stem cells from Jim’s bone marrow, prepares them, and injects them into his knee. Tag along with Brenda as she interviews Jim at home following his recovery.
Dr. McKenna discusses Jim’s case with Brenda and explains why stem cell injections alone are not necessarily the best solution to knee problems, including Jim’s. He also touches upon the FDA’s current role regarding regulations.
Dr. Riordan talks about how the proprietary amniotic membrane tissue product used by RMI can enhance bone marrow stem cell therapy and the safety aspects of such treatments.
Stem Cells II
Stem Cell Institute in Panama: Spinal Cord Injury, Multiple Sclerosis (MS), Rheumatoid Arthritis (RA) and More…
Brenda Watson takes you inside the Stem Cell Institute and Medistem Labs in Panama. If you have ever wondered what stem cell therapy is like in Panama, this show is for you.
See inside the laboratory and clinic as Brenda follows three patients through the treatment and recovery process: Sam Harrell (MS), Juan Jose Ballareno (Spinal Cord Injury) and Todd Rinehart (RA).
Meet the team as she interviews key players:
Neil Riordan, PhD, Founder and Chief Scientist of Medistem Labs, explains how the Panamanian government regulates stem cells in Panama. He discusses how HUCT-MSCs work on RA before delving into the subject of clinical trials in Panama and the USA.
Medical director, Jorge Paz Rodriquez, MD discusses how HUCT-MSCs work and why they can be transplanted without immune system rejection.
Rodolfo Fernandez, Medistem Panama Laboratory Director talks about tissue selection and processing.
Applied Stem Cell Therapy Expert, Neil Riordan, PhD, Authors “Cell Therapy for Liver Failure: A New Horizon” in Contemporary Liver Transplantation Medical Reference
DALLAS-FORT WORTH, TEXAS (PRWEB) NOVEMBER 08, 2016 (Original Press Release on PRWeb)A new chapter by renowned applied stem cell therapy expert, Neil Riordan, PhD of the Riordan-McKenna Institute in Southlake, Texas; Medistem Labs Panama, and the Stem Cell Institute in Panama City, Panama, entitled, “Cell Therapy for Liver Failure: A New Horizon” is now available in the printed and online medical reference, “Contemporary Liver Transplantation – The Successful Liver Transplant Program”.
Contemporary Liver Transplantation provides a comprehensive review of the most crucial and provocative aspects of liver transplantation. The reference covers all disciplines involved in a multidisciplinary liver transplant team; provides a valuable resource for surgeons, hepatologists, anesthesiologists, transplant coordinators and administrators, amongst others; addresses organizational issues that are vital to the good performance of transplant programs; and offers the first 360-degree analysis of liver transplantation.
Liver failure is the seventh largest cause of death in industrialized countries. It occurs as a result of a number of acute and chronic clinical inciting factors, including drug-/alcohol-induced hepatotoxicity, viral infections, vascular injury, autoimmune disease, or genetic predisposition. The only available cure, liver transplantation, is severely limited by a lack of donors and further complicated by the adverse effects of chronic immune suppression.
In his chapter on stem cell therapy for liver failure, Dr. Riordan examines pre-clinical data and analyzes published clinical trials to identify promising sources of autologous stem cells to treat liver failure including: bone marrow mesenchymal stem cells (BM-MSC), adipose tissue MSC (AT-MSC), and bone marrow mononuclear cells (BMMC) including their purified forms. In addition, he delves into allogeneic stem cells such as those harvested from umbilical cords after normal, healthy births.
“Many liver failure patients contact our clinics in Panama and Texas asking if there is anything we can do for them. Unfortunately, we have to tell them that we cannot treat liver failure. Even though some clinical trials have shown signals of efficacy, which is encouraging, I don’t think sufficient rationale exists to treat liver failure patients with the types of stem cells I’ve studied at present,” stated Dr. Riordan.
About Riordan-McKenna Institute (RMI)
RMI specializes in non-surgical treatment of acute and chronic orthopedic conditions using *amniotic tissue allograft and bone marrow aspirate concentrate (BMAC) that is harvested using the patented BioMAC bone marrow aspiration cannula. Common conditions treated include meniscal tears, ACL injuries, rotator cuff injuries, runner’s knee, tennis elbow, and joint pain due to degenerative conditions like osteoarthritis.
Additionally, RMI augments orthopedic surgeries with BMAC and amniotic tissue allograft to promote better post-surgical outcomes and uses amniotic membranes as part of a complete wound care treatment regimen.
BMAC contains a patient’s own mesenchymal stem cells (MSC,) hematopoietic stem cells (CD34+), growth factors and other progenitor cells. Amniotic tissue allograft is composed of collagens and other structural proteins, which provide a biologic matrix that supports angiogenesis, tissue growth and new collagen during tissue regeneration and repair.
*Amniotic tissue is donated after normal healthy births.
Riordan-McKenna Institute Website: http://www.rmiclinic.com
801 E. Southlake Blvd.
Southlake, Texas 76092
Tel: (817) 776-8155
Toll Free: (877) 899-7836
Fax: (817) 776-8154
About Stem Cell Institute Panama
Founded in 2007 on the principles of providing unbiased, scientifically sound treatment options; the Stem Cell Institute (SCI) has matured into the world’s leading adult stem cell therapy and research center. In close collaboration with universities and physicians world-wide, our comprehensive stem cell treatment protocols employ well-targeted combinations of autologous bone marrow stem cells, autologous adipose stem cells, and donor *human umbilical cord stem cells to treat: autism, cerebral palsy, multiple sclerosis, spinal cord injury, osteoarthritis, rheumatoid arthritis, heart disease, and autoimmune diseases.
In partnership with Translational Biosciences, a subsidiary of Medistem Panama, SCI provides clinical services for ongoing clinical trials that are assessing safety and signs of efficacy for autism, multiple sclerosis, osteoarthritis, rheumatoid arthritis, and spinal cord injury using allogeneic umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC) and hU-MSC-derived mesenchymal trophic factors (MTF). In 2017, Translation Biosciences plans to expand its clinical trial portfolio to include heart disease and cerebral palsy.
*umbilical cord tissue is donated after normal, healthy births
For more information on stem cell therapy:
Stem Cell Institute Website: http://www.cellmedicine.com
Stem Cell Institute
Via Israel & Calle 66
Plaza Pacific Office #2A
Panama City, Panama
About Medistem Panama Inc.
Since opening its doors in 2007, Medistem Panama Inc. has developed adult stem cell-based products from human umbilical cord tissue and blood, adipose (fat) tissue and bone marrow. Medistem operates an 8000 sq. ft. ISO 9001-certified laboratory in the prestigious City of Knowledge. The laboratory is fully licensed by the Panamanian Ministry of Health and features 3 class 10000 clean rooms, class 100 laminar flow hoods, and class 100 incubators.
Medistem Panama Website: http://www.medistempanama.com
About Contemporary Liver Transplantation
Edited by Cataldo Doria, Contemporary Liver Transplantation provides a comprehensive review of the most crucial and provocative aspects of liver transplantation. It represents a unique source of information and guidance for the current generation of transplant surgeons that evolved from being pure clinicians into savvy administrators knowledgeable in every regulatory aspect governing transplantation.
The book contains 35 chapters covering every single aspect of the surgical operation in the donors as well as the recipients of liver transplants. The pre-operative work-up, as well as the post-operative immunosuppression management and the treatment of recurrent diseases are addressed in detail. Single chapters are dedicated to controversial issues like transplantation in patients diagnosed with NASH, transplantation for patients diagnosed with HCC beyond Milan criteria and usage of HIV positive donors. Dedicated chapters on HCV, HCC, FHF and NASH will make this book a unique resource for any health care provider part of the multidisciplinary liver transplant team.
The book goes beyond the analysis of the formal medical and surgical aspects of liver transplantation and introduces deep knowledge on key aspects of contemporary transplant programs, such as: physical rehabilitation, palliative care, pregnancy, the multiple requirements of regulatory agencies ruling transplantation, quality measurements for transplant programs, finance and liability.
The book is organized in 9 sections focusing on each key aspect of liver transplantation. Contemporary Liver Transplantation addresses the need and the questions of the multidisciplinary group involved including surgeons, Hepatologists, anesthesiologists, infectious disease specialists, radiologists, transplant coordinators, financial specialists, epidemiologists and administrators.
Contemporary Liver Transplantation Online: http://www.springer.com/us/book/9783319072081
The U.S. Food and Drug Administration held public hearings for two days this week to allow for public commenting on proposed guidance relating to the regulation of human cells, tissues or tissue-based products.
In its current form, this guidance will classify a woman’s own fat tissue as a drug when used in breast reconstruction procedures. This is certainly bad news for the over 100,000 female cancer patients who seek this procedure each year.
According to the FDA, the sole purpose of a woman’s breast is to lactate. Of course that begs the question of what the purpose of a man’s breast might be but we will leave that for another day. Since fat from other parts of the body does not produce milk, it cannot be transferred into a woman’s breast.
Specifically, in its industry guidance entitled Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance, the FDA states, “The basic function of breast tissue is to produce milk (lactation) after childbirth. Because this is not a basic function of adipose [fat] tissue, using HCT/Ps from adipose tissues for breast augmentation would generally be considered a non-homologous use.” “Homologous use” refers to a tissue’s ability to serve the same “basic function or functions” as the tissue into which it is being transplanted. So in this case, “non-homologous” use equals FDA-regulated “drug”.
That’s right ladies. Your fat tissue is an FDA-regulated drug if your doctor wishes to use it to help reconstruct your breasts following a mastectomy unless she goes through the FDA drug approval process, which can take a decade or two and cost upwards of 2 billion dollars. Needles to say, this is a financial burden that no doctor, clinic or hospital can bear. Once finalized, this new guidance will effectively shut the door on using a woman’s own fat tissue to help reconstruct her breasts.
And it doesn’t stop there. According to the FDA, in most cases, our own cells are drugs too. An FDA panel member even went so far as to state that our blood is an FDA-regulated drug.
For example, if your doctor wants to remove a small sample of bone marrow from your hip and inject part of it into your knee because she has read the literature and believes it can help you heal without surgery, the FDA says that’s verboten because you guessed it – it’s a drug that is subject to the full FDA drug approval process.
As the FDA becomes increasing intrusive in our lives, restricting the ability of licensed medical doctors to practice medicine, one has to wonder where it all will end? The answer seems to be that once the FDA has its way, our bodies, down to the very last cell, will be classified as drugs, and therefore subject to federal regulation by the FDA.
If you agree that the FDA has no business outlawing the use of your own fat tissue to reconstruct your breasts, please spread the word and ask your friends, family members and doctors to let the FDA know what you think before September 27th by commenting here: https://www.regulations.gov/comment?D=FDA-2014-D-1856-0061
You might also consider contacting your local congressman, congresswoman, and state senators.
FDA DRAFT STEM CELL GUIDANCE DOCUMENTS EXPOSED AS IMPROPER RULEMAKING, BAD SCIENCE AND HEARTLESS PUBLIC POLICY
There was a wide spectrum of opinions. Some stem cell companies involved in clinical trials wanted the non-clinical trials clinics shut down. But at least there were representatives from some of these “unproven” clinics and interest groups who made some important points about the rights of patients and how the needs of patients are not being met by the current clinical trials model as it applies to stem cells. I heard a number like 250,000 people are not getting the stem cell treatments they need because of clogged research and regulatory hold-ups. There were numerous calls from very serious, highly credentialed people for the FDA loosen its death grip (my term) restricting access to these therapies, and the thrust of most of these presenters was that these draft guidance documents make thinks much worse.
The guidance documents are really bad and deny access for many
And that was the big takeaway for me; that the guidelines were much, much worse than even I thought. I understood that the guidelines would make illegal the 21 CFR 1271.15 exempt same surgical procedures provided by many of the 600 plus unregulated stem cell clinics.
But what I didn’t understand until Monday’s hearing is that the FDA intends to radically change the rules so that, for example, the most popular form of breast reconstruction surgery post mastectomy (flap something) would become illegal under the new guidelines. Many other popular and widely successful procedures in other areas like orthopedics would be eliminated (outside of clinical trials). We’re not talking unboarded docs with no relevant experience who take a weekend course and starts shooting people up with stem cells. We’re talking about big-time breast reconstructive surgeons, highly regarded orthopedists and other highly skilled and specialized physicians who have successfully worked with tens of thousands of patients. If the FDA gets its way, according to these folks, Poof! These best practices transplant procedures are gone.
Fortunately, there were some very smart professionals making presentations, including an extremely knowledgeable law professor from Boston College, Mary Ann Chirba. She and several other people with regulatory expertise made the case that this whole guidance exercise was an illegitimate attempt to pass new rules without complying with the rulemaking requirements under federal law. Works for me!
They and others honed in on the radical revisions to the two key preexisting terms/concepts used by the FDA to work its illegal magic: homologous use and more than minimal manipulation.
What’s a “main function?”
It was also pointed out that the guidance documents invented a new concept not existing in the statute or rule, namely the “main function” of a cell or HCT/P which is used as a way of forcing stem cell procedures from just registration under 362 into the IND/NDA drug approval path. It was argued persuasively by several regulatory experts that the creation of this new concept and its resulting transfer of many heretofore legal uses of stem cells into illegal new drug products turns the guidance documents into rulemaking without following federal administrative rulemaking procedures.
The FDA doesn’t understand what fat does
Another extremely cogent criticism made by a variety of people including Professor Chirba, other regulators and by both of the two top presenting stem cell researchers, Arnold Caplan and Keith March had to do with the FDA’s view of fat. According to the guidance documents, fat just has a structural function. But these presenters and especially March and Caplan showed that the FDA’s view was biologically unsound. Fat has definite, known and extremely important non-structural uses, starting with energy storage and continuing to assistance in the healing function. The FDA’s unscientific, unsubstantiated restriction on fat allows it to find most of the important uses of fat and fat stem cells illegal as either non-homologous or as a more than minimally manipulated product. The FDA was absolutely and repeatedly pummeled on this point by my count, at least a half dozen very, smart experts. I don’t see how even the FDA, which has a very particular agenda, is going to be able to hold on to its limitations/restrictions on fat/adipose tissue.
The Big Guys say regulations are holding back progress
The two big-time researchers (Caplan and March) also made the point that the regulatory climate is holding back research. Kaplan said that some bone marrow pioneers had observed that if they had the regulatory environment back then as what exists today, bone marrow transplants might never have taken off. Ouch!
Interestingly, Peter Rubin, the plastic surgeon who last Thursday presented the inspiring cases of reconstruction work from fat transfers, presented again. This time he was more critical of the FDA and stated that many of the most successful reconstructive plastic surgery procedures, including breast reconstruction would become illegal under the draft guidance documents. He and many other excoriated the draft homologous document which classifies fat tissue for breast reconstruction as non-homologous because the primary purpose of the breast is lactation. Several of the female presenters had some polite but pointed words to the FDA about that. Most of the day’s presenters agreed that regulation/regulatory expense was delaying bringing this technology to patients.
The 3 Billion Dollar Player Weighs-in
The biggest dollar player was the California Stem Cell Institute which has a 3 billion dollar budget and 12 research centers. Its director spoke, and his message was clear, concise and right on the money (and with 3 billion, it should be). The FDA has to loosen-up its grip and find an intermediate path between unregulated stem cell clinics and full-on clinical trials, because there is a desperate unsatisfied need and that need will be satisfied – just as water flowing down a hill will find a path – with or without the FDA’s help. He was very persuasive. Reminds me of an old TV ad: “When EF Hutton talks, people listen.”
Interestingly, no one picked up on what I though was the most egregious over reach in the draft guidelines, namely that the FDA tacitly incorporated or read the homologous and more than minimally manipulated requirements from registration facilities (1270.10) into the exemption for same surgical procedures (1271.15). Under the actual rule (1271.15) same day surgical procedures can do non-homologous and more than minimally manipulation. At least those two terms are not in that rule. Legal Method 101 says that if terms are in 1271.10 but not in 1271.15, then they’re in in 1271.15. (Maybe too technical. I’ll have more to say about that another time.)
Maybe there is a viable lawsuit
Something else I realized as a result of a couple of the astute presentations. I said in the last post that you can’t sue on a guidance document because it’s just the agency’s “current thinking.” However, if a guidance document is really disguised rulemaking without meeting the rule changing requirements, then maybe there is a lawsuit. Many presenters were clear about the fact that these guidance documents are disguised rule changes, so I’m now more optimistic about the chances of a legal challenge.
People are Mad and are going to do something about it
And speaking of possible legal challenges, while all of the presenters were very professional, very cordial, ostensibly courteous and complimentary to the FDA panel members on the dais, I sensed that quite a few, many in fact, were pretty upset by what the FDA is trying to do with the draft guidance documents.
So here is my prediction/wish/what I hope to make happen. There won’t be one lawsuit filed if the draft guidelines go into effect. There will many lawsuits. I don’t think these folks are going to go quietly. My sense is that the big players, sophisticated players, like Rubin, the fellow who started a society and has 5800 members, the guy with dozens of clinics, they have seen too many good results to give up their most effective tools. All these guys either run or are closely connected to prestigious professional societies and I predict that many of them are going to try to stop these guidance documents, in court or in Congress.
I hope for everyone’s sake the FDA really listened today, because people are mad as hell and there not going to take it. They want better and quicker access to this new technology, and my hope is they will get it.
Rick Jaffe, Esq.
Larry North has been helping people become healthy for over 25 years. He’s done this with three best-selling books, seminars, and gyms. These people were no different than you. The only difference is that they chose to make a change in their life. Now it’s your turn. Don’t put it off any longer. Let Larry help you become an even better you. Here’s Larry North.
Larry: Hey everyone. We had a cold front. It went from 105 degrees down to 97. It was really like a cool breeze for everyone in North Texas. This is the Better You show. I’m just thrilled! I’m always seeking to help you in my quest to deliver the best experts, the best guests, the best technology, the best medical advice that you could possibly get; be it exercise or nutrition, and of course your health. My guest is Dr. Neil Riordan, chairman of MedStem out of Panama. There’s so much to talk about. He’s published dozens and dozens of scientific articles, [and] internally peer reviewed journals. He’s just a cutting edge expert when it comes to stem cells. In fact, he and his colleagues have published articles together on MS, spinal cord injuries, heart failure, arthritis, autism. He’s also CEO of Riordan-McKenna Institute right here in Southlake. So he’s local, but he’s actually more international that he is local. Just happens to be close by, consults with numerous universities, and I consider him a friend. You flew in from Wichita, which is where you’re from, right?NR: Yeah, that’s my hometown. We were doing a fund raiser for a young man who has Duchenne’s muscular dystrophy, and originally we started treating him in Panama using stem cells from umbilical cords, and he responded very well, and he responds each time he gets treated, but we have to keep treating him. It’s a very long-term treatment. He has to get new cells every 4-6 months. He is the first person in the US to get umbilical cord stem cells for any indication, and we’re under the FDA. They’ve given us an investigational new drug, compassionate use, because he was treated seven times out of the country, but they gave us the green light for him to get treated in the country. He’s been treated now three years, every four months now, and when he gets those stem cells his breathing goes up, everything improves. In fact, now, eight years later since his first treatment, he’s in better health now than he was at 22, and he’s about 30 and a half.
Larry: I’ve been around you long enough and I’ve heard these types of stories, I really hope we can inspire a lot of our listeners. I’d like to start from the beginning. Your father was really kind of a holistic pioneer when it came to better health, was he not?
NR: Absolutely. My father and later myself, we did a lot of work on cancer therapy, and what we worked most on was intravenous vitamin C for cancer treatment, decades ago, back when that was really quackery. Now we have universities like Thomas Jefferson starting their third clinical trial using intravenous vitamin C for cancer patients, university of Iowa, even Johns Hopkins has started a study. Some of these ideas take time to catch on, but they’re really catching on now.
Larry: What was it like growing up with a father so cutting edge, so way ahead of his time?
NR: I think in retrospect now I realize how brave he was in doing the things he was doing. As my brother says, you can recognize a pioneer by the arrows in his back. He certainly had a few, but I think his legacy is that those arrows were unwarranted, and now you have major universities carrying on the research. The quality of life of cancer patients when they get intravenous vitamin C has improved. It’s been proven. More and more literature comes out, and he’s being vindicated.
Larry: What I’ve found, and this is why I’m so excited to have you, what I’ve found is that I know just enough about stem cells to really be dangerous when I try to educate people, and I don’t. Most people really have no clue. They’ve heard of stem cells. They think they know a little bit about it, but they’re really not sure. They’ll just be inquisitive. Where did all the stem cell research start?
NR: It actually started with one of our other research projects alongside the vitamin C research at the Riordan Clinic in Wichita, where we were looking at host non-toxic therapies for cancer. One of them…, there are cells in your body called dendritic cells. They are commanders of the immune system. They tell the immune system what to do, and in cancer patients they’re being blocked. One way to overcome that blockade to the immune system is by enhancing these dendritic cells and harvesting white blood cells to convert to dendritic cells. That was late 80s, and I left in the 90s to start my own clinic to actually make dendritic cells, to make cancer-therapeutic vaccines for cancer patients. I was in the Riordan Clinic for fourteen years, working on intravenous vitamin C and dendritic cell vaccines.
Larry: Interesting. What are the most common types of stem cells people have available to them today? I want to talk about that, and also, why umbilical? From what I’ve read, if you want stem cells that’s where you want to go, but I understand there are other options. You were able to treat this young man locally, but most people have to go out of the country. What were the early stages of stem cell options for people and where has it evolved to?
NR: First I want to exclude embryonic and fetal stem cells, which are subject to a lot of debate–religious and ethical–and we want to exclude that because that’s not even part of our conversation. It’s from an ethical and scientific standpoint that we’ve never utilized or even studied embryonic or fetal stem cells. We only use what’s classified as adult stem cells, and what’s included in that, is after a full-term healthy birth, we call those post-natal or adult stem cells. Once a healthy, normal life has begun on until your demise, those are all considered adult stem cells, and we can separate those into two major categories: one is blood-forming stem cells that are formed in your bone marrow, and those are called hematopoetic stem cells or blood-forming cells because that’s what they do. There’s a lot of confusion these days about those cells being used to treat cancer or MS, but those cells don’t really treat anything. When you hear about a cancer patient being treated with stem cells, they’re actually being treated with chemotherapy and/or radiation, in the hope that they get a high enough dose to kill the cancer, but it also kills your bone marrow’s ability to produce blood cells, so you die of an infection or you die of bleeding or something like that. The stem cells in that world are a rescue, not a treatment. Your stem cells are gone. They’ve all been obliterated, so you need new stem cells and start making all these blood products again. The world we’re in are repair stem cells -the repair stem cells are found throughout your body called MSCs. We use the term MSC for mesenchymal stem cells. We have them throughout our body and as we age, they become fewer in number, and as we age they lose their ability to fix things. They become less robust. So you have them in your fat, your bone marrow, every organ in your body. The healthiest, most robust stem cells from a non-dangerous, non-controversial source are from the umbilical cord. If we look at the potency of umbilical cord MSCs compared to mine, I’m 57 years old, my cells are going to divide once every 50-60 hours, whereas the umbilical cord cells divide every 24 hours, which doesn’t sound like a lot, until you look at the numbers. One cell after 30 days you’re going to have a billion cells from one if they divide every 24 hours. If you look at my cells in a lab, I’ll have a pitiful 2-300 cells after that period of time. It’s not just the cells, but it’s also what the cells secrete, molecules that stimulate regeneration. Our cells because we’re over the age of 50, they do not produce as many of those factors that stimulate regeneration, they’re also less robust their capacity to modulate the immune system and decrease inflammation. We all know that inflammation is the real key to aging.
Larry: You’ve touched on a lot of things. You are so brilliant and so smart. You’re a scientist. One of the great things about having you, is that this is the future of medicine, and being able to explain to people how they work. I want more stories from people who are actually, truly changing their lives as the result of stem cells, but I also want to talk to you about the confusions. I’ve had some friends who have gone to Houston and had some body fat taken out of their body, processed, and what are the benefits of that vs. umbilical? We’ll come back and talk about that. [Commercial break] We’re talking about the umbilical stem cells. Let’s say someone lives in Dallas. How would they know if they’re a candidate for stem cells?
NR: Typically we would want them to go to our website, and we’d want them to read all about what we do what we don’t do there. [www.cellmedicine.com]
Larry: So let’s say they go to the site, and one of my sponsors here is BioMedical and they’re about hormone optimization, and I love that your clinic actually does BioT. So if you’re thirty, and you test your testosterone levels and it’s high, let’s say above 800, they’d tell you you’re not a candidate for it. What tells you about who needs stem cells?
NR: We have a number of protocols. One of the things we do most of is we treat autoimmune diseases, and one of the indications we have is multiple sclerosis, rheumatoid arthritis and others. The cells are very good when you infuse them in the vein. They change the auto-immune environment in the body. If someone wants to explore it as a treatment option, they’d go to the site and read about what we do and fill out an application. We have six MDs that work at the Stem Cell Institute in Panama. They review every case and will call them and typically ask them for medical records.
Larry: I’ve been there, to Panama, visited and got to work with your medical professionals, and I found it an amazing experience because for me, it was orthopedic because of the fact that I was a body-builder back in the 70s and 80s and we did things back then we probably shouldn’t have done. We sort of didn’t know any better. After being in several auto accidents, my neck, my back, my knee, and I have to tell you I had stem cells directly into the knee, and prior to meeting you I thought I was going to have to have surgery. In the month or so since we last saw each other, I don’t know what’s going on in my body but I’m feeling amazing. I want more of that! For me it was orthopedic. For others listening, you talked about inflammation, and stem cells are definitely able to help with that.
NR: Absolutely. They’re producers of the anti-inflammatory molecules in your body, the producers of your natural ibuprophen or naproxine. A lot of people, if they have a lot of arthritis, that’s another one of our protocols. Osteoarthritis, they don’t need to take those things anymore. We can inject right into the joint as well as do intravenous [injections]. The cells have this capacity to home to inflamed areas and respond to the situation to make the appropriate antibodies.
Larry: Let’s open up the phone lines. Let’s go to Said in Arlington:
Said: I am 60 years old and have been diagnosed with diabetes for six years. My A1C average is about 7-7.2. My question is, is there any research on diabetes and diabetic people? Will what you do help me?
NR: We don’t treat Type 2 diabetes in Panama, but there was a very good study done by the University of Miami, and they used bone marrow stem cells from the patient themselves, isolated the stem cells and pushed the stem cells into the pancreas, and if I remember correctly got a reduction in hemogloben A1C of 2.5 points was the mean for 20-some patients. I can post that study to my blog for you.
Said: Did that study proceed further?
NR: That was a one-time study and they followed the patients for a year. The procedure itself took one day, the bone marrow harvest, concentrating, and then the injection.
Said: What I have read, all these pharmaceutical companies are making money, tons of money, so naturally they don’t want anyone to promote to cure this disease. I’m sure there is a cure but no one wants to do the research.
Larry: Also, with Type 2, you do want to exercise, eat right, have your hormones in balance, take good care of yourself. That’s one of the best ways you can deal with your overall health and wellness, which you do control. Good luck to you. Neil, so, help me out here. Stem cells is a hot topic right now but you’ve been doing this for decades. You’ve devoted your life to it. I’ve seen and I’ve read on social media that locally, people are offering stem cells you can get locally. But really, without that special dispensation you have for one patient, what are people doing that are saying they can get it from a local clinic here.
NR: In our case at RMI in Southlake, we do stem cell therapy but we’re limited by FDA to using the patient’s own bone marrow. We also use amnion from afterbirth that has growth factors to make your bone marrow perform younger. We’ve got Dr. Wade McKenna, our board certified orthopedic surgeon. He does treatments using the patient’s own bone marrow in a relatively painless extraction procedure. He uses that in combination with amnion and with surgery. In his words, he likes to take big surgeries and make them small surgeries, and small surgeries and make them injections.
Larry: It’s a relatively new clinic but he’s busy, right?
NR: Yep, he’s done thousands of surgeries using bone marrow in Decatur and now he’s here, only for orthopedics, but we have another doctor there for overall wellness and optimization and hormone replacement therapies.
Larry: What led you to umbilical stem cells over other forms of stem cell treatment?
NR: It was mainly the science. One of the misconceptions is that the cells actually become new tissue. We have people come to us asking for new bladders and new body parts. These cells do not do that. These cells do home to places of inflammation in your body. That’s the sweet spot for these MSCs and they secrete substances that turn off these inflammations, and another sweet spot is autoimmune disease. If you look at what they secrete and their activity on the immune system and compare that to fat stem cells, you can get MSCs from your own fat, if you compare that, you have way more modulation potency from the umbilical cord than you do from your fat.
Larry: That’s quite significant.
NR: Basically you have to get this rock over a hill from an immune standpoint, and you can get halfway up the hill and it doesn’t do any good. If you want to get the rock over the hill, the best way to do it is with the best cells that produce the right molecules that stimulate your immune system to normalize.
Larry: The science agrees with you, there’s no question, but in the early stages, where did you go to get the cells in the first place?
NR: In Southlake, we have specialized equipment that allows us to take out the bone marrow, and we also have the amnion product that “hops up” the bone marrow. In Panama, we have a 16,000 square foot laboratory where we isolate the stem cells from umbilical cells, grow them out, freeze them down, and then we thaw them as required for use. All the hard work in Panama is in the laboratory because the actual therapy is nothing more, as you know.
Larry: Now, are there a lot of labs in the world that produce those types of cells?
NR: There’s about a handful. We’re creating a wedge with this Duchenne’s, and we’re creating a wedge for larger studies with more individuals.
Larry: Our callers touched upon it a little bit with pharma, I imagine there’s a lot of red tape and lobbying and I imagine pharma’s a lot of the pushback on why you’re not able to have your labs all over the United States.
NR: If you take rheumatoid arthritis as an example, and there was a study that came out where they treated over 172 people with umbilical MSCs, and all of them improved, after one infusion.
Larry: This is huge for those patients, because it’s very painful and there’s no cure before stem cells.
NR: If you look at the drugs that you hear about all the time watching television, you see these anti-rheumatic drugs over and over again, and they represent a 14 billion dollar industry in the US. So if you have a competitor that’s not yet FDA approved, there’s not going to be a great deal of pharma support for that.
Larry: Am I wrong in believe that the future is here, stem cells are going to be much bigger in peoples’ lives than they ever imagined?
NR: Yeah, I think it’s definitely right up there with vaccinations and antibiotics as far as the next leap forward in medicine, and as congressman Joe Barton pointed out in a meeting we had a couple of months ago, the truth always comes out. Sometimes it takes longer, and in this case the effectiveness of these cells, the safety of these cells, the naturalness of these cells, all those truths will become self evident at some point. How long it takes, I don’t know. There are other countries investing and building a regulatory process that will speed things up. For example, Japan has put in rules and regulations that will speed things up. Germany, South Korea, and Taiwan are right behind Japan. They’re going to allow for innovation like we’ve never seen before. If we don’t do something in this country, we’re going to be left in the dust. So, Japan’s rule basically states that once you prove the safety of your product, it can go to market for seven years, and in that seven years you can demonstrate what it’s effective for. I think we need something like that in this country if we’re going to stay competitive. There’s a bill being revised right now called the Renew Act. I don’t know that that’s going to make it, but we need something like it or for one of the states to create a statute much like medical marijuana, where the state of Colorado has said in spite of federal regulations we’re going to allow this and the attorney general’s going to back us up. I think Texas has a pretty good chance of that. I just got back from Kansas, and they’ve got a pretty good chance too.
Larry: Partly because of you! You’re at the forefront pushing and lobbying and really trying to create awareness.
NR: If you look at the economic benefit, I hate to use marijuana as a comparative, but if you look at the economics in Colorado, the state coffers are swollen with cash, and I think that would happen if a state were to say to the federal government, this is what we’re going to do. There’s enough evidence of safety, certainly with the patient’s own stem cells, with the post-natal stem cells, there’s enough safety data that one state will stand up, or the federal government’s going to have to make a break.
Larry: Any parting words?
“We enjoy the advantage of having a large amount of clinical data on 2,000 patients. So we analyzed who received which cells and which cells worked best in different conditions. This allowed us to create our selection process through molecular profiling,” explained Medistem (Panama) Founder and CEO Dr. Neil Riordan.
Operating what is arguably the country’s most advanced laboratory, an 8,000-sq-ft facility in the City of Knowledge science and technology cluster, Medistem has raised its profile in recent years as it develops stem cell-based products for clinical trials for treatment of autism, asthma, multiple sclerosis, osteoarthritis, rheumatoid arthritis and spinal cord injuries.
Utilizing its patented technologies, Medistem harvests human adult stem cells from umbilical cords, tissues and blood as well as from bone marrow and adipose tissue. “We have intellectual property on a methodology for basically defining which are good cells, which are mediocre and which are the useless ones. The U.S. Food and Drug Administration has approved our cells for compassionate use in the United States. This is a big step,” Riordan said.
Compassionate use, also known as expanded access, refers to the use of investigational new drugs outside of a clinical trial by patients with serious, life-threatening conditions. After finishing its first prospective clinical trial, and with six others in the pipeline, the company is considering the favorable regulatory conditions for cell therapy in Japan, now a promising market for its products.
“Japan has a law on the books that allows a company of our size to commercialize such products. That makes it our number one priority. We are gearing up to present our data to regulators, as well holding talks with potential partners over there,” Riordan added.
An article published this month in Thieme Journal of Knee Surgery entitled, “The Use of Biologic Agents in Athletes with Knee Injuries” concluded that “Biologic agents… are becoming the mainstay of nonoperative therapy in the high-demand athletic population.” but “…Unfortunately, strict regulations by the FDA continue to restrict their application in clinical practice.”
The good news is they also believe, “As the volume and quality of evidence continue to grow, biologic agents are poised to become an integral component of comprehensive patient care throughout all orthopedic specialties.”
The article is authored by Michaela Kopka and James P. Bradley from the Department of Orthopaedic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
Biologic agents are gaining popularity in the management of bony and soft tissue conditions about the knee. They are becoming the mainstay of nonoperative therapy in the high-demand athletic population.
The most well-studied agents include platelet-rich plasma (PRP) and stem cells—both of which have shown promise in the treatment of various conditions. Animal and clinical studies have demonstrated improved outcomes following PRP treatment in early osteoarthritis of the knee, as well as in chronic patellar tendinopathy. Early clinical evidence also lends support for PRP in the augmentation of anterior cruciate ligament (ACL) reconstruction. Research investigating the role of biologic agents in collateral ligament and meniscal injuries is ongoing.
Studies assessing the utility of stem cells have shown encouraging results in the setting of osteoarthritis.
Unfortunately, strict regulations by the FDA continue to restrict their application in clinical practice. A major limitation in the interpretation of current data is the significant variability in the harvesting and preparation of both PRP and stem cells.
As the volume and quality of evidence continue to grow, biologic agents are poised to become an integral component of comprehensive patient care throughout all orthopedic specialties.
Registered Nurse and Stem Cell Recipient, Teresa Hamrick tells her uplifting story about how bone marrow stem cell therapy augmented with AlphaGEMS amniotic tissue product got her out of a wheelchair. Teresa received her treatments at the Riordan-McKenna Institute (RMI) in Southlake, Texas. RMI is Dr. Riordan’s new orthopedic stem cell clinic. For more information, please visit: www.rmiclinic.com
Why Stem Cells Work: Clinical Trials for Spinal Cord Injury, Multiple Sclerosis, Rheumatoid Arthritis, and Duchenne’s Muscular Dystrophy
Neil Riordan, PhD speaks at the Riordan-McKenna Institute and Stem Cell Institute fall seminar in Southlake, Texas on October 10, 2015.
Dr. Riordan discusses:
- How our lab selects uses specialized screening techniques to select only the stem cells that we know will be the most useful for our patients. Only about 1 in 100 cords pass this screening process.
- How umbilical cord mesenchymal stem cells (MSC) control inflammation, modulate the immune system and stimulate regeneration.
- How the number and function of our own stem cells decline over time.
- How MSC secretions promote healing
- Where MSCs are found in our body
- First clinic trial in the US using umbilical cord tissue-derived stem cells
- How MSC doubling times dramatically decrease as people age, which is why cord cells are much more robust than a patient’s own cells as they age
- The origin of Medistem Lab in Panama
- Why the Stem Cell Institute and Medistem Labs are in Panama
- Stem cell therapy laws and approvals around the world
- Global interest in mesenchymal stem cell therapy research
- Current clinical trials using mesenchymal stem cells
- Clinical trials in Panama
- Collaborations with corporations and educational institutions
- Mesenchymal stem cell selection, donor selection, and testing
- Brief tour of Medistem Panama stem cell laboratory
- Isolation and production of mesenchymal stem cells
- Discovery of mesenchymal stem cells in menstrual blood
- Umbilical cord mesenchymal stem cell studies for rheumatoid arthritis
- The role of T-regulatory cells in rheumatoid arthritis and multiple sclerosis
- Treating spinal cord injuries with mesenchymal stem cells
- Mechanism of mesenchymal stem cells on spinal cord injury. They are not becoming tissue. It’s their secretions that allow the spinal cord to heal itself.
- Umbilical cord MSC studies on spinal cord injury
- Data from Stem Cell Institute spinal cord injury patients
- Video from treated spinal cord injury patients
- Postnatal MSC safety
- MSCs and cancer risk – MSCs have been shows to actually inhibit tumor growth