New Study Suggests Healthy Donor Stem Cells Better Than MS Patient’s Own Stem Cells

Pre-Existing Inflammatory Diseases Reduce Therapeutic Potential of Stem Cells for MS Treatment, Study Shows

BY ALICE MELÃO (Original Story from Multiple Sclerosis News Today)

Pre-existing inflammatory diseases affecting the central nervous system make mesenchymal stem cells (MSCs) less effective in treating multiple sclerosis (MS), concludes a study by researchers at Cleveland’s Case Western Reserve University School of Medicine.

Diseases like EAE and MS diminish the therapeutic functionality of bone marrow MSCs, prompting re- evaluation about the ongoing use of autologous MSCs as a treatment for MS,” the team wrote, adding that its study supports the advancement of MSC therapy from donors rather than autologous MSC therapy to treat MS while raising “important concerns over the efficacy of using autologous bone marrow MSCs in clinical trials.

The study, “CNS disease diminishes the therapeutic functionality of bone marrow mesenchymal stem cells,” notes that MSCs potentially produce several signaling proteins that can regulate immune system responses as well as help tissue regenerate. Preclinical studies have shown that this can reduce brain inflammation while improving neural repair in animal models of experimental autoimmune encephalomyelitis (EAE). This model resembles the inflammation and neuronal damage seen in MS patients.

Given the need for effective new MS therapies, the results will help MSCs to advance to human clinical trials. So far, results have reported good safety data, though such therapies have failed to demonstrate therapeutic efficacy. Most such trials so far have used stem cells collected from the patient, a process known as autologous transplantation — yet this may explain why MSCs have not been effective. It’s possible that pre-existing neurological conditions may alter stem cells’ responsiveness as well as their therapeutic activity.

To see whether that is in fact the case, team members collected stem cells from the bone marrow of EAE mice. But these stem cells were unable to improve EAE symptoms, whereas stem cells collected from healthy mice retained all their therapeutic potential and improved EAE symptoms.

A more detailed analysis showed that the MSCs derived from EAE animals had different features than their healthy counterparts.

In addition, the team confirmed that MSCs collected from MS patients were also less effective in treating EAE animals, compared to MSCs from healthy controls. Indeed, these MSCs from patients produced pro-inflammatory signals instead of the protective anti-inflammatory ones.

“Diseases like EAE and MS diminish the therapeutic functionality of bone marrow MSCs, prompting re- evaluation about the ongoing use of autologous MSCs as a treatment for MS,” the team wrote, adding that its study supports the advancement of MSC therapy from donors rather than autologous MSC therapy to treat MS while raising “important concerns over the efficacy of using autologous bone marrow MSCs in clinical trials.”

FDA DRAFT STEM CELL GUIDANCE DOCUMENTS EXPOSED AS IMPROPER RULEMAKING, BAD SCIENCE AND HEARTLESS PUBLIC POLICY

Go to Original Post on RickJaffe.com

FDA-NotApprovedStampToday was a good day for people who want continued access stem cells outside of clinic trials, and also for people who want the FDA to allow faster access to this promising technology.

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.

www.rickjaffe.com

Neil Riordan, PhD discusses stem cell therapy on Larry North’s “Better you Show” – CBS KRLD 1080am

Picture of Larry North

Larry North

KRLD 1080

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?

Image of Neil Riordan, PA, PhD

Neil Riordan, PA, PhD

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?

NR: I think the best resource is www.cellmedicine.com and RMIclinic.com. It tells you everything we do and don’t do.

Stem cell pioneer sets sights on Japan – Japan Times features Neil Riordan, PhD of Medistem Panama

Japan Times Article Medistem

“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.

Umbilical Cord Tissue Mesenchymal Stem Cells Best For Clinical Applications

A recent study concluded that umbilical cord tissue is the best source for clinically utilizable mesenchymal stem cells.

Comparative Characterization of Cells from the Various Compartments of the Human Umbilical Cord Shows that the Wharton’s Jelly Compartment Provides the Best Source of Clinically Utilizable Mesenchymal Stem Cells.


Arjunan Subramanian, Chui-Yee Fong, Arijit Biswas, Ariff Bongso

Department of Obstetrics and Gynaecology, Yong Loo Lin School of Medicine, National University Health System, National University of Singapore, Kent Ridge, Singapore, 119228, Singapore

Mesenchymal Stem Cell Harvesting Picture

Abstract

The human umbilical cord (UC) is an attractive source of mesenchymal stem cells (MSCs) with unique advantages over other MSC sources. They have been isolated from different compartments of the UC but there has been no rigorous comparison to identify the compartment with the best clinical utility. We compared the histology, fresh and cultured cell numbers,morphology, proliferation, viability, stemness characteristics and differentiation potential of cells from the amnion (AM), subamnion (SA), perivascular (PV), Wharton’s jelly (WJ) and mixed cord (MC) of five UCs. The WJ occupied the largest area in the UC from which 4.61 ± 0.57 x 106 /cm fresh cells could be isolated without culture compared to AM, SA, PV and MC that required culture. The WJ and PV had significantly lesser CD40+ non-stem cell contaminants (26-27%) compared to SA, AM and MC (51-70%). Cells from all compartments were proliferative, expressed the typical MSC-CD, HLA, and ESC markers, telomerase, had normal karyotypes and differentiated into adipocyte, chondrocyte and osteocyte lineages. The cells from WJ showed significantly greater CD24+ and CD108+ numbers and fluorescence intensities that discriminate between MSCs and non-stem cell mesenchymal cells, were negative for the fibroblast-specific and activating-proteins (FSP, FAP) and showed greater osteogenic and chondrogenic differentiation potential compared to AM, SA, PV and MC. Cells from the WJ offer the best clinical utility as (i) they have less non-stem cell contaminants (ii) can be generated in large numbers with minimal culture avoiding changes in phenotype, (iii) their derivation is quick and easy to standardize, (iv) they are rich in stemness characteristics and (v) have high differentiation potential. Our results show that when isolating MSCs from the UC, the WJ should be the preferred compartment, and a standardized method of derivation must be used so as to make meaningful comparisons of data between research groups.

The researchers considered the following factors in their in-depth analysis:

  • Fresh live cell counts
  • Cell counts after culture
  • Cell morphology
  • Cell proliferation
  • Cell viability
  • CD marker analysis
  • Telomerase analysis (TRAP assay)
  • Pluripotent marker analysis
  • Genomic markers
  • Cell differentiation
  • Degrees of differentiation

Click the link below to read the entire article.

Mesenchymal Stem Cells From Umbilical Cord Tissue Are Best in Clinical Applications

Stem Cell Therapy for Knee Pain and Injuries – Teresa Hamrick’s Story

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

Stem Cell Therapy: Study finds that autologous bone marrow disc injections significantly reduce lumbar disc pain

A study published last year (2015) in the scientific journal Stem Cells entitled “Percutaneous injection of autologous bone marrow concentrate significantly reduces lumbar discogenic pain through 12 months”, reported that patients suffering from chronic back pain due to degenerative disc disease who were treated by injecting their own bone marrow aspirate concentrate (BMAC) into their lumbar discs experienced significant pain reduction 12 months after treatment.

Woman Back PainDegenerative disc disease (DDD) is a term used to describe normal changes in spinal discs as one ages. Spinal discs separate the spinal vertebrae and act as shock absorbers that allow the spine to twist, bend and flex. DDD usually affects the discs in the lower back (lumbar) or the neck (cervical).

DDD in lumbar discs can cause lower back pain, osteoarthritis, abnormal disc bulging (herniated disc) and spinal stenosis (narrowing of the tunnel-like space that holds the spinal cord), any of which can exert pressure on spinal nerves and the spinal cord causing pain and affecting nerve function.

BMAC contains mesenchymal stem cells and CD34+ stem cells. Mesenchymal stem cells have been shown to promote tissue growth including cartilage and CD34+ stem cells can promote tissue vascularization, thus increasing blood supply to new or damaged tissue.

The researchers studied 26 patients who were suffering from discogenic lower back pain. Patients were followed up at 3, 6, and 12 months.

After 12 months, 21 out of 26 patients experienced statistically significant improvements in pain scores and impairment. The most dramatic improvements were seen in patients with higher stem cell counts.

The original publication can be found here: http://onlinelibrary.wiley.com/doi/10.1002/stem.1845/epdf

At Riordan-McKenna Institute, Dr. Riordan’s orthopedic stem cell clinic in Dallas-Fort Worth, Dr. McKenna performs a procedure for degenerative disc disease that is similar to the one described in the Stem Cell Journal study.

However, Dr. McKenna augments the BMAC injections with *AlphaGEMS amniotic tissue product. AlphaGEMS is a pliable tissue allograft (transplant) derived from human placental amnion, which contains over 100 growth factors and functions as a biologic structural matrix to facilitate and enhance tissue healing and repair. The inclusion of AlphaGEMS adds a new dimension to the tissue repair process that was successfully tested in the cited study.

“Since we perform lumbar disc injections with BMAC and AphaGEMS at RMI, we are encouraged to see an independent study published that shows the effectiveness of a similar procedure for patients suffering from discogenic lumbar back pain,” states Riordan-McKenna Institute Medical Director, Wade McKenna, DO.

For more information about BMAC and AlphaGEMS treatment at RMI, please visit: http://www.rmiclinic.com/non-surgical-stem-cell-injections-joint-pain/stemnexa-protocol/

If you are suffering from degenerative disc disease and would like to be evaluated for treatment at RMI, the first step is to complete an online medical history. Once we receive it, our staff will contact you to answer general questions and to guide you through the rest of the evaluation process, which usually requires recent MRI images and an MRI report.

https://secureform.rmiclinic.com/forms/13299/3207/VVp7/form.html


*AlphaGEMS tissue is procured from contracted hospitals after normal, healthy births

Stem Cell-Augmented Achilles Tendon Rupture Repair Yields Excellent Results

Int Orthop. 2015 May;39(5):901-5. doi: 10.1007/s00264-015-2725-7. Epub 2015 Mar 22.

Outcomes of acute Achilles tendon rupture repair with bone marrow aspirate concentrate (BMAC) augmentation

Stein BE, Stroh DA, Schon LC.

“Excellent results, including no re-ruptures and early mobilisation, were observed…”

Abstract

Kobe-AchillesPURPOSE:
Optimal treatment of acute Achilles tendon ruptures remains controversial. Positive results using stem-cell-bearing concentrates have been reported with other soft-tissue repairs, but no studies exist on outcomes of bone marrow aspirate concentrate (BMAC) augmentation in primary Achilles tendon repair.

METHODS:
We reviewed patients with sport-related Achilles tendon ruptures treated via open repair augmented with BMAC injection from 2009 to 2011. Data on operative complications, strength, range of motion, rerupture, calf circumference and functional improvement through progressive return to sport and the Achilles tendon Total Rupture Score (ATRS) were analysed.

RESULTS:
A total of 27 patients (28 tendons) treated with open repair and BMAC injection were identified (mean age 38.3 ± 9.6 years). At mean follow-up of 29.7 ± 6.1 months, there were no reruptures. Walking without a boot was at 1.8 ± 0.7 months, participation in light activity was at 3.4 ± 1.8 months and 92% (25 of 27) of patients returned to their sport at 5.9 ± 1.8 months. Mean ATRS at final follow-up was 91 (range 72-100) points. One case of superficial wound dehiscence healed with local wound care. No soft-tissue masses, bone formation or tumors were observed in the operative extremity.

CONCLUSIONS:
Excellent results, including no re-ruptures and early mobilisation, were observed in this small cohort with open Achilles tendon repair augmented by BMAC. No adverse outcomes of biologic treatment were observed with this protocol. The efficacy of BMAC in the operative repair of acute Achilles tendon ruptures warrants further study.

LEVEL OF EVIDENCE:
IV – Therapeutic.

Ruptured Achilles Tendon Treatment at Dr. Riordan’s Clinic in Dallas-Fort Worth

At Riordan-McKenna Institute, Dr. McKenna performs a procedure for achilles tendon rupture that is similar to the one described in this study. However, Dr. McKenna augments the BMAC injection with AlphaGEMS amniotic tissue product. AlphaGEMS is a pliable tissue allograft (transplant) derived from human placental amnion, which contains over 100 growth factors and functions as a biologic structural matrix to facilitate and enhance tissue healing and repair. The inclusion of AlphaGEMS adds a new dimension to the tissue repair process.

For more information about BMAC and AlphaGEMS treatment at RMI, please visit: http://www.rmiclinic.com/non-surgical-stem-cell-injections-joint-pain/stemnexa-protocol/

If you have suffered a ruptured achilles tendon and would like to be evaluated for treatment at RMI, the first step is to complete an online medical history. Once we receive it, our staff will contact you to answer general questions and to guide you through the rest of the evaluation process, which usually requires recent MRI images and an MRI report.

https://secureform.rmiclinic.com/forms/13299/3207/VVp7/form.html

Recent Study Concludes Patients’ Own Stem Cells with Core Decompression Could Delay or Avoid the Need for Hip Replacement

A recent University of Rome study published in Acta Orhopaedica Belgica entitled “Stage-Related Results In Treatment Of Hip Osteonecrosis With Core-Decompression And Autologous Mesenchymal Stem Cells” reported that avascular hip necrosis patients treated with a combination of bone marrow aspirate concentrate (BMAC) and surgical core decompression experienced significant improvements that could delay or avoid the need for hip replacement.

Femoral Head RoundedOsteonecrosis is the death of bone tissue caused by lack of blood supply to the bone. Another name for osteonecrosis is avascular necrosis. Tiny breaks in the bone caused by avascular necrosis can eventually lead to bone collapse. If the bone is fractures or becomes dislocated, its blood supply can be cut off. Early stage avascular necrosis may be treated with a combination of physical therapy, however most people with avascular necrosis will eventually need surgery including total joint replacement.

Core decompression is surgical procedure that involves removing part of the inside of the bone to relieve pressure and allow new blood vessels to form.

BMAC contains mesenchymal stem cells and CD34+ stem cells. Mesenchymal stem cells have been shown to promote tissue growth including cartilage and CD34+ stem cells can promote tissue vascularization, thus increasing blood supply to new or damaged tissue.

The researchers studied 29 patients (31 total hips) with Stage I and Stage II avascular osteonecrosis of the femoral head (AVNFH). The femoral head is the “ball” end of the thigh bone that fits into the hip socket. Patients were followed-up for two years after their procedures.

After 2 years, 25 out of 31 hips showed a relief of symptoms and a resolution of the osteonecrosis. The researchers concluded, “…treatment of AVNFH with implantation of autologous concentrated MSCs is indicated for patients at Stage I and Stage II”. They went on to state, “Our results show a significant reduction of joint pain level, and this could take to a delay, or avoid the need, of hip replacement.” Another significant finding was the association of corticosteroid therapy to a larger chance of treatment failure.

The original publication can be found here: http://www.actaorthopaedica.be/acta/download/2015-3/09-Persiani%20et%20al.pdf

At Riordan-McKenna Institute, Dr. McKenna performs a procedure for AVFNH that is similar to the one described in the Italian study. However, Dr. McKenna augments the BMAC injection with AlphaGEMS amniotic tissue product. AlphaGEMS is a pliable tissue allograft (transplant) derived from human placental amnion, which contains over 100 growth factors and functions as a biologic structural matrix to facilitate and enhance tissue healing and repair. The inclusion of AlphaGEMS adds a new dimension to the tissue repair process that was successfully tested in Rome.

“Since we perform core decompression with stem cell therapy at RMI, we are encouraged to see independent study results published that show the effectiveness of a similar procedure for patients with avascular necrosis of the femoral head,” states Riordan-McKenna Institute Medical Director, Wade McKenna, DO.

For more information about BMAC and AlphaGEMS treatment at RMI, please visit: http://www.rmiclinic.com/non-surgical-stem-cell-injections-joint-pain/stemnexa-protocol/

If you are suffering from avascular osteonecrosis of the femoral head and would like to be evaluated for treatment at RMI, the first step is to complete an online medical history. Once they receive it, RMI staff will contact you to answer general questions and to guide you through the rest of the evaluation process, which usually requires recent MRI images and an MRI report.

https://secureform.rmiclinic.com/forms/13299/3207/VVp7/form.html

Study Shows Bone Marrow Stem Cells Help Tennis Elbow

Tennis Elbow

A study published in the Jul-Dec 2014 edition of the Journal of Natural Science, Biology and Medicine entitled Bone marrow injection: A novel treatment for tennis elbow concludes that a single injection of bone marrow aspirate concentrate (BMAC) into the elbow lead to significant improvement of patients suffering from tennis elbow.

The study followed 30 patients for 12 weeks and concluded that treatment of tennis elbow patients with single injection of BMA showed a significant improvement in short to medium term follow-up.

Perhaps more importantly, it concluded that, “In future, such growth factors and/or stem cells based injection therapy can be developed as an alternative conservative treatment for patients of tennis elbow, especially who have failed non-operative treatment before surgical intervention is taken.”

Fast forward to the present where at RMI, we are augmenting BMAC with *AlphaGEMS, a proprietary, pliable tissue allograft (transplant) derived from human placental amnion, which functions as a biologic structural matrix to facilitate and enhance tissue healing and repair. AlphaGEMS contains 108 different growth factors including WNT-4 and prostaglandin.

Prostaglandin inhibits inflammation, which occurs after injury and marks the beginning of the healing process. The faster we can tame this inflammation, the sooner the body can move on to the next phase of healing, regeneration. It’s important to note that AlphaGEMS has more than 60 times the amount of prostaglandin compared to other products.

WNT4 is arguably the single most important molecule required for wound healing. AlphaGEMS has more than 10 times the amount of WNT4 as competing products.

For more information about BMAC and AlphaGEMS at the Riordan-McKenna Institute Click Here.

If you are suffering from tennis elbow and would like to be evaluated for treatment, please start by completing our online medical history. Once we receive it, our staff will contact you to answer general questions and guide you through the rest of the application process, which usually includes a in-office evaluation with Dr. McKenna for local patients or a free telephone consultation for those who live further away.

Apply Today

About Tennis Elbow

Tennis elbow is an inflammation of the tendons that join the forearm muscles on the outside of the elbow. The forearm muscles and tendons become damaged from overuse — repeating the same motions again and again. This leads to pain and tenderness on the outside of the elbow. More on Tennis Elbow from AAOS.

About: Bone marrow injection: A novel treatment for tennis elbow

Abstract

Objective:

The objective of this prospective study was assessment of efficacy of bone marrow aspirate (BMA) (containing plasma rich in growth factors and mesenchymal stem cells) injection in treatment of tennis elbow.

Materials and Methods:

A total of 30 adult patients of previously untreated tennis elbow were administered single injection of BMA. This concentrate was made by centrifugation of iliac BMA at 2000 rpm for 20-30 min and only upper layer containing platelet rich plasma and mononuclear cells was injected. Assessment was performed at baseline, 2 weeks, 6 weeks and 12 weeks using Patient-rated Tennis Elbow Evaluation (PRTEE) score.

Results:

Baseline pre-injection mean PRTEE score was 72.8 ± 6.97 which decreased to a mean PRTEE score of 40.93 ± 5.94 after 2 weeks of injection which was highly significant (P < 0.0001). The mean PRTEE score at 6 week and 12 week follow-up was 24.46 ± 4.58 and 14.86 ± 3.48 respectively showing a highly significant decrease from baseline scores (P < 0.0001). Conclusion:

Treatment of tennis elbow patients with single injection of BMA showed a significant improvement in short to medium term follow-up. In future, such growth factors and/or stem cells based injection therapy can be developed as an alternative conservative treatment for patients of tennis elbow, especially who have failed non-operative treatment before surgical intervention is taken.




*Tissue used for AlphaGEMS is donated after normal, healthy births. Once it has been fully tested for infectious diseases, sterility and a few other things, the tissue is processed by using proprietary methods developed by Neil Riordan, PhD.