I was at the Personalized Lifestyle Medicine Institute’s annual conference in 2015 in Chicago. I was on the edge of my seat listening to Dr. Richard Burt of Northwestern University report on the amazing outcomes he was seeing in his research using stem cell therapy in MS and other autoimmune conditions. I immediately suggested to a patient of mine that she be evaluated for inclusion. Unfortunately, she was denied entry into his trial for a handful of reasons, including previously prescribed medications. While my patient is responding to a FxMed approach, the possibility of progressing further with stem cell therapy became inspiring for her. We decided to continue looking.
As you probably know, stem cell therapy outside of the research setting is the Wild West. It’s offered everywhere, here and outside of the US (there’s a whole “stem cell tourism trade”). Radical claims are made routinely without much evidence or oversight. Pricing for therapy and protocols used vary widely, although anyone (even those participating in research trials) can expect to spend thousands of dollars.
Given that my patient has MS, I reached out to Dr. Terry Wahls and asked if she had any insight into a direction for us. She suggested I look into a massive, years-long multi-center clinical trial using stromal vascular fractions (AKA adipose-derived stem cells and growth factors) for a variety of conditions, including MS. The first publication from this study out February 2017, focusing on the safety of SVF over 5 years, demonstrated a very low number of adverse events, and significant improvement in pain rating in a variety of musculoskeletal diseases. (N =1524)
Note that this research project is patient-funded and the involved clinics are for-profit centers. Not surprisingly, this is a strong criticism lodged against it. That said, they are following a strict IRB-approved protocol, gathering data and importantly, publishing it. Their goal is FDA approval.
This far-reaching study deserves a second look, for sure.
I reached out to Dr. Tami Meraglia, who heads one of the many clinic sites. Turns out Dr. Meraglia–who started in aesthetic medicine, as many early adaptors of adipose-derived stem cell therapy do, given their familiarity with liposuction and fat transfer —originally looked into stem cell therapy to assist her father, who was struggling with COPD.
Through a serendipitous cancelation, leaving me in need of a podcast interview, what started out as a scheduled conversation to discuss a potential patient referral evolved into April’s interview!! I am eager to hear what you think: Are you a clinician referring for stem cell therapy? Are you opposed? Are you thinking about bringing it to your clinic? Are you a patient thinking about stem cell therapy? Have you already received stem cell therapy? If yes, I’d appreciate hearing about your experience with it.
In this podcast, you’ll learn about:
- The FDA trial currently underway
- Overview of adipose-derived stem cell
- Conditions included in the study, appropriate indications for stem cell therapy
- Osteoarthritis: stem cells vs PRP or prolotherapy
- Outcome data?
- Breast cancer and stem cell therapy
- Cost, insurance
- Banking stem cells
- Outcome with Dr. M’s father
Kara Fitzgerald: Hi, everybody. Welcome to New Frontiers In Functional Medicine. I’m your host Dr. Kara Fitzgerald and today I have a really, really interesting topic that I’m learning about actually. We’re going to be talking about all things stem cells today. I’m talking to Dr. Tami Meraglia. She is the medical director at Seattle Stem Cell Center. She’s actually involved in a national clinical trial right now that she’ll tell us about. She is double board certified in aesthetic medicine as well as integrative and natural medicine. In fact, she is a member of the Institute for Functional Medicine. I think she’s just well trained in a lot of modalities in our world.
She’s passionate about creating natural aesthetic results in her patients. She can help and discover and correct medical conditions, hormone deficiencies, hormone imbalances and just help people look and feel beautiful and energetic. I am grateful to have her on today to talk about just this amazing emerging field using stem cell therapy. Welcome to New Frontiers, Dr. Meraglia.
Tami Meraglia: Thank you for having me. I’m excited.
Kara Fitzgerald: I know. I am too. Listen, you come from aesthetic medicine. You’re in the natural/functional world and now you’re the medical director at Seattle Stem Cell Center. Talk to me about your entry into using stem cells in practice and just talk to me a little bit about just an overview, an introduction to stem cells therapy.
Tami Meraglia: Yes, absolutely. Well, I’m an MD that’s board certified in naturopathic medicine. That’s where the sort of impetus came from, but also my father has COPD and there is no cure for that. I kept pumping up against “well, stems cell for COPD” and so I kept researching and researching and researching. I was invited to be medical director at a few overseas stem cell clinics. That just didn’t feel right. It didn’t feel like it had the safety. I’m a very cautious physician. I was able to align and join a group, here in the United States, that has a national clinical trial that’s registered with the FDA.
Kara Fitzgerald: Let me just back up for a second. I do, I want to hear about the trial actually, but you came upon stem cells and started to research them because you wanted to help your dad with COPD? That was your entry?
Tami Meraglia: Yeah.
Kara Fitzgerald: Okay. Then you started investigating overseas, as many of my patients are doing, in their journey towards wellness. In particular, you and I were talking about, you and I connected because Terry Walsh referred me to you for some MS patients that I want to refer your way. Your journey is a really personal one. The obviously you were inspired by the efficacy or the possibility of them and then came on board here. Okay.
Tami Meraglia: Yeah, absolutely. Then, I have a functional medicine, naturopathic medicine practice. I have patients that have been with me for over ten years. We have a membership model. They just keep coming and then we keep refining and fine tuning and making sure that they’re optimally healthy. I thought, “What can I do? What more can I do? How can I bless their life even more?” Especially the arthritis and I have a couple of patients who have MS and a couple who have Parkinson’s and there just was nothing more I could do. [inaudible 00:04:08] a nutrition good, adrenal hormone holistic approach, I kind of bumped up against a wall. Then my other practice that I started many years ago was as a cosmetic physician that sort of helped pay the bills early on. I danced at, my first career was dancing as a soloist in a ballet company for 13 years, so it was fun to have the artistry of cosmetic medicine as well.
Many, many stem cell surgeons are cosmetic physicians because we all did liposuction. Way back when, we were doing fat transfers for cosmetic purposes and going, “Huh, there’s something about this. It’s really amazing.” That really led to a lot of the research about what’s in fat. What is it? Now, we know that fat is not just a great source of stem cells, but we also know that it’s an organ and it produces hormones. It has enzyme activity that takes testosterone and converts it into estrogen. There’s all kinds of things that fat does, other than just give you cushion.
Kara Fitzgerald: Right, right, right. Kind of a natural … you guys are using adipose, hence your adipose derived stem cells, hence your interest. Geez, that’s really, that’s really fascinating. Yeah. You guys would be, practicing aesthetic medicine, well suited towards working with adipose.
You trained in this and then you brought it into your clinic. Talk to me about what’s happening in using these in various conditions. We’ll talk about the various conditions that you’re using them for, but what’s the mechanism around this therapy or the mechanisms?
Tami Meraglia: Well, we don’t know everything, but what we do know is that stem cells are what we call pluripotent. They can become, with the right messaging, basically any cell. At first, I was totally in awe and amazed and shocked and I’m still in awe of it because it’s pretty remarkable, but it actually makes sense. It was first described to me quite some time ago when I was doing dome training with our group. The physician that was doing a training and I was saying, “Oh my gosh. It’s so amazing. It can create new cartilage, it can create ne brain tissue and it can create myelination for the MS patients. This is so amazing.”
He said, “Is it?” He says, “If you were the power that be, whether you think it’s God or evolution or whatever it is, would you create hundreds and thousands of millions of backup cells to replace every single thing that’s going on in the body when it wears out or would you create a reservoir of something that could become whatever is needed.”
Kara Fitzgerald: Right.
Tami Meraglia: I thought, “Huh, I guess that’s a good way of looking at it.” That’s what’s going on. We know that in the early days of this study, we actually tagged the stem cells with radioactive nucleotides and ended imaging to watch well where do these go and how do they know where to go? If I give you an IV, how do I know it’s going to go to your lungs or to your left shoulder or to your brain? It does.
Kara Fitzgerald: Wow. It goes to the site with the dominant lesion in the body, the dominant area that needs repair?
Tami Meraglia: It seems to. Who knows, there’s probably a cytokine [inaudible 00:08:27] messaging pathway that we yet to completely elucidate. The body is unbelievably amazing. I think the more we find out, the more we realize we don’t know.
Kara Fitzgerald: Yeah. Geez, it’s just really interesting to me. If you introduce stem cells into somebody who has MS, but they also happen to have osteoarthritis, would it be efficacious of both sites, the central nervous system and say the knee, if that’s the site potentially?
Tami Meraglia: Yes. Give everybody IV so that that can go where it goes, but we’ve also found that there’s increased efficacy for joints when we also inject into the joint. That could be because of [inaudible 00:09:17]. We don’t know. The inside of the capsule of the knee is not very vascular. Anybody who’s had a knee surgery, it’s not a bloody surgery.
Kara Fitzgerald: Right. Okay. Specifically for that, you do, for osteoarthritis you’re doing local injections, otherwise-
Tami Meraglia: Plus IV.
Kara Fitzgerald: Plus IV. You’re using adipose. Why not other stem cells? Overseas it seems like a lot of embryonic tissue. I think in the research setting here, we’re using embryonic tissue, but people are harvesting stem cells from a variety of locations. What are your thoughts on that?
Tami Meraglia: Since we have a clinical trial that registered the FDA, our goal is to have FDA approval. We felt like, first of all, using embryonic sources was a more difficult path for approval because of the controversy and the ethics. Second of all, autoimmune conditions are very much a part of what we treat. I think that if you talk to Terry Walsh, she thinks that it’s all autoimmune. Everything that’s happening to us has an autoimmune component to it. It think she’s right. Why would you use something that’s foreign, when you’re trying to treat an autoimmune condition? Would the risk of an inflammatory response because your body is really smart. It knows self from not self normally. When you have an autoimmune condition, it’s so confused that it’s attacking itself and then you put something foreign into it.
The other part of embryonic is that embryonic cells are rapidly dividing. They’re designed to make an entire human being in nine months. There’s a fear that there’d be an increased risk of tumor formation and cancer.
Kara Fitzgerald: Right. That makes sense. Has any of that born out? Is it too new to actually see long-term outcome with embryonic?
Tami Meraglia: There’s some studies that suggest that there is a slight increased risk of tumor formation and cancer with embryonic cells, but I’m not sure how good those studies are. We’ve done over 5,000 cases. We’re in our six year of our clinical trial and there has been a zero increase of tumors and cancers. It’s from you. There’s no possibility of rejection or a foreign inflammatory response. There’s no, thus far in 5,000 cases, there hasn’t been any increased risk of tumors or cancers and nobody minds donating a little bit of fat.
Kara Fitzgerald: Right, right. True. Yeah. All right. Well, listen, I want, just give me a little overview on the study that you’re doing.
Tami Meraglia: It’s a national clinical trial. We have an IRB number and all that jazz. That’s really, really nice from my perspective because it means that I don’t have to and I don’t get to do anything my way. I have a protocol that I follow with the exact equipment, the exact process, the exact same algorithms, so that our patients can be reassured that their statistical chance of success is the same as what we’ve been seeing everywhere. That’s how good studies are done. Multicenter studies are done that way. I love that we’re doing that. We recently published the largest safety paper in U.S. on stem cell medicine of this year. That was really exciting.
We have many arms of our study. There’s currently the only conditions that exclude you from the study are active cancer or an active infection, but we are starting and hope to, by the end of this year, have a cancer arm to this study.
Kara Fitzgerald: Oh, interesting. Okay. Looking at stem cells specifically in different cancers? Can you talk about that a little bit?
Tami Meraglia: Yes. We have early, early, small case studies of breast tumors completely dissolving,
Kara Fitzgerald: Oh, fascinating. Okay. Using adipose derived stem cells.
Tami Meraglia: Yeah. The technical term is stromal vascular fraction.
Kara Fitzgerald: Okay, thanks.
Tami Meraglia: That’s, stem cells are what everybody knows, but it turns out it’s stem cells in all of the juicy stuff that those stem cells need to do their work.
Kara Fitzgerald: Right. Got it. Yup. I actually have that, the SVF paper. Is this the study that you’re referring to? I want to make sure that I have the citation and a link to the study that you just referenced.
Tami Meraglia: I can send you the link to the safety paper and you can double check if that’s the one you have.
Kara Fitzgerald: Perfect. Okay. If anybody, actually I’m sure loads of people are interested in that study and just make sure I’ll get that citation and, Tami, any other citations you think people would be interested in, we’ll pop them right on the website. We’ll also incidentally, folks, put Tami’s contact information and it’s the SeattleStemCellCenter. Is it .net?
Tami Meraglia: .net, yes.
Kara Fitzgerald: Okay.
Tami Meraglia: Yeah. All of these resources and pieces of information are also on SeattleStemCellCenter.net.
Kara Fitzgerald: All right. Let’s talk about the conditions that you’re addressing. You mentioned a couple of them and outcome data because I know you’ve been gathering a lot. I think this whole network of clinics participating in this research study, you guys have been pulling together a lot of clinical outcome data. What are you treating and what are you seeing?
Tami Meraglia: Well, we all in the United States started off in stem cell medicines treating orthopedic conditions. Those are the conditions, people who have been told that they need to have a knee replacement surgery, shoulder replacement surgery, those kinds of things. They’re the people that we have the longest data on and the highest numbers because there’s so many people that have those conditions. As opposed to MS or Parkinson’s or interstitial cystitis and things like that that people just, the numbers are not the same. It’s unbelievably successful.
For example, the data on the knee is 80% of patients who get the SVF from us have a success with their treatment.
Kara Fitzgerald: Wow.
Tami Meraglia: My husband, he was told by two orthopedic surgeons that he had to have a shoulder replacement surgery. He’s out of pain, lifting weights at the gym that he hasn’t in over ten years. He just thinks it’s a miracle. I would have to caution people that there’s nothing in medicine that works 100% of the time for 100% of the people. We’re not making and claims and we’re not making any promises. This is the same. It doesn’t work for some people. We don’t know why. That’s why we’re doing the research, but we want to make sure that we don’t over promise things, but it is pretty exciting.
Kara Fitzgerald: That’s amazing. Let me just ask you, how severe? Osteoarthritis is up to advanced stages, stage four, which would, I’m assuming that’s a bone on bone. Where are you guys seeing turn around? Are you able to affect- Yeah, go ahead. Go ahead. Go ahead.
Tami Meraglia: There’s a paper on that. The stage four, where there was no perceived cartilage at all left over, had a lower success rate. Up until that point, when there was … that sort of leads you back to, okay, maybe this getting in the area, looking at the cartilage and saying, “Okay, we need more of this. Let’s make more of this.” Maybe that’s why it’s more successful when there is cartilage still left there.
Kara Fitzgerald: Right, Right. How does it compare to, say, some of the more common interventions like PRP or some of the other injectables that they’re using?
Tami Meraglia: Night and day.
Kara Fitzgerald: Yeah.
Tami Meraglia: Night and day with regard to efficacy. Night and day with regard to the duration of success. PRP and prolotherapy and things like that, that hurts.
Kara Fitzgerald: Right.
Tami Meraglia: It hurts like crazy.
Kara Fitzgerald: Right.
Tami Meraglia: This does not. People often feel a relief the next day because stem cells are very, very anti inflammatory. Our very first patient in our study, patient number one, was a knee patient. She’s never had another treatment yet.
Kara Fitzgerald: Wow. Now is she the exception?
Tami Meraglia: No.
Kara Fitzgerald: Okay.
Tami Meraglia: No, not in orthopedic conditions, but what we have found is that if patients have chronic or progressive medical conditions, then they do benefit from more than one treatment over time, which makes sense because we aren’t curing things. How can you cure something if you don’t even know what causes it?
Kara Fitzgerald: Tell me about the conditions you’re using this in and seeing good outcome with?
Tami Meraglia: Autoimmune conditions, MS, Parkinson’s, the orthopedic conditions, interstitial cystitis, traumatic brain injury, heart conditions, congestive heart failure, MI, heart attack, stroke, the list is extensive.
Kara Fitzgerald: Well, let me ask you this. What are you not using it in? Just cancers at this point?
Tami Meraglia: Yeah, cancer and active infection.
Kara Fitzgerald: Otherwise, you’re basically recommending it?
Tami Meraglia: Yes, with making sure that the patient is given a true informed consent and not promised anything because people say, “Well, it’s experimental.” It’s not experimental. We know it works, not all of the time, but we know it works. What it is is investigational. We’re investigating what is it that makes it work this time and not that time.
Kara Fitzgerald: Hmm-hmm(affirmative). What’s the outcome data?
Tami Meraglia: With what do you mean? I’m sorry.
Kara Fitzgerald: What kind of success, would you say, that you’re seeing in these conditions?
Tami Meraglia: Each condition is being followed. That’s the wonderful thing about having a clinical trial is that there’s a whole database that just follows patients along. Each condition is treated differently. It has a different success rate. Orthopedic conditions, like knees, they have one of the highest success rates at 80-85%. Some conditions are much, much lower. Whether that’s because the numbers are lower and if we see higher numbers, then we’ll see a better outcome, maybe. Maybe it’s just not. For example, ankylosing spondylitis. That does not seem to be treated very well. The success rate is much lower than many other conditions.
Kara Fitzgerald: Right, right.
Tami Meraglia: We just talk one on one with every patient and try to give them some reassurance of what it could do. Here’s the exciting part. In over 5,000 cases, no one has gotten worse. Nobodies been hospitalized. No bleeding, no infections, no deaths, no tumors, no cancers. I would challenge people to find a medication or surgery that has that on the list of possible outcomes and side effects.
Now, does it means that it’s impossible and it’s never going to happen? No. It is possible that it will make somebody worse. It is possible that somebody will get an infection. At 5,000, it hasn’t happened yet, so I like to think that it’s not probable at this stage.
Kara Fitzgerald: Yeah, that’s amazing. Just circling back to the ankylosing spondylitis and the lower response rate, we know that’s associated with gut infections, klebsiella and so forth. I’m assuming you’re concurrently in your practice, well maybe not in the research study. You might have guidelines around this, but outside of it are you, you’re employing functional medicine, I’m assuming with these patients as well. Is that right?
Tami Meraglia: I think that’s the biggest thing that we’re doing that’s different than everyone else. You’re right. It’s not the whole clinical trials, it’s me, because that’s the way my brain works, Dr. Walls is brilliant. Why don’t we get every MS patient to do stem cells and the Walls protocol?
Kara Fitzgerald: Yeah, exactly.
Tami Meraglia: There are some really profound new research about Parkinson’s in the gut and something called butyrate that is produced in the gut from one of the microbiomes. We dig into that. I spent the last year researching so what’s going one here and how do these cells get made? It goes back to the mitochondria and the energy to do all of this cell generation. I’ve created an entire stem cell nutrition guide and created a recipe book that I give to each and every patient so that the mitochondria has everything that it needs to be at full capacity.
Kara Fitzgerald: Are these the patients that are participating in the study or no?
Tami Meraglia: Yes.
Kara Fitzgerald: Oh, they are. Oh, okay. Okay. They can actually be in the study and have the additional support. It makes entire sense to me that doing a full functional approach would improve your outcome immeasurably. Are the data that you’re pulling together your outcome data as opposed to some of the other colleagues in this trial? Is it different if they’re not employing a functional approach? Can I ask that? Do you know that, out of curiosity?
Tami Meraglia: I don’t know that because I don’t have the exact details of everyone else’s outcome.
Kara Fitzgerald: Access. Hmm-hmm(affirmative).
Tami Meraglia: I have exceedingly high response rates and maybe that’s why. I didn’t want to be the center that when they gather all the data at the end to publish the conclusion, that they’d look at my site and go, “What the hell?”
Kara Fitzgerald: This outlier site.
Tami Meraglia: Yes.
Kara Fitzgerald: That’s really, really cool. That’s really, really cool. This little blip on the screen. What’s going on over there?
Tami Meraglia: Yeah, that’s investigate that instead of throwing it out.
Kara Fitzgerald: When does the study end?
Tami Meraglia: Our goal is FDA approval.
Kara Fitzgerald: Interesting. Is there a time on it?
Tami Meraglia: Well, we have to [inaudible 00:26:20] with the pharmaceutical companies and everybody else who’s got opinions about this, so no. Nobody knows.
Kara Fitzgerald: Okay. Okay.
Tami Meraglia: I’m just grateful we can do it legally, above the boards, in the United States, in a transparent manner because stem cell medicine is like the wild wild west right now.
Kara Fitzgerald: Yes.
Tami Meraglia: There are a lot of stem cell clinics popping up. There are chiropractors who have never done surgery time, who are piercing the body cavity and doing stem cell medicine from … I get a little bit concerned about what’s going on.
Kara Fitzgerald: Yup. Absolutely understandable. Absolutely understandable. I know. I was just, actually a patient of mine emailed recently on a Costa Rican location, actually started by a group out of Arizona that was just recently shut down. I don’t know why. I don’t know the details. It might not be, they might be absolutely above board, but you’re right. The fact is how we vet what you’re doing and advise our patients is and how patients figure this out, who want to go and participate, it is. It’s the wild west. It’s nice that you’re following this and that I think you’ve got this FDA approval and you’re following a structure. You’ve got the safety publication out, demonstrating really good results there. I appreciate that as well. Obviously, you’re actively recruiting.
What about clinicians interested? There’s no doubt after people hear some of the physicians that hear this podcast, myself included, how would one enter into learning about this?
Tami Meraglia: They can contact me. I have a lot of physicians that I sort of help get them lined up. There’s the clinical trial that does the training for entering the clinical trial. Then I have some physicians that I help do the holistic approach and my protocols and my resources and all of that, so that they can just treat patients.
Kara Fitzgerald: That’s great. I really appreciate it. All right. Just a couple of wrap up questions. You, I just noticed on your site that you guys are banking stem cells.
Tami Meraglia: Yes.
Kara Fitzgerald: Talk to me about that a little bit. It sounds kind of, it’s interesting.
Tami Meraglia: It’s pretty new. I did very little of it. I extract an additional harvest of the fats for the purpose of shipping it to another company that does the stem cell banking. I do not have, nor do I want to have a license to store people’s biologic material.
Kara Fitzgerald: Basically if they need it later on, boom. You get it and they can be injected or receive another IV.
Tami Meraglia: Yeah, exactly. There’s enough cells there, we can replicate them and grow them and expand them. There’s enough cells there for 15 or 20 treatments, so how amazing for the patients with those chronic medical conditions.
Kara Fitzgerald: Yeah. What about cost? There’s definitely a wide range of pricing, some extremely exorbitant, a little bit more, some of it more realistic.
Tami Meraglia: I think that the cost is unfortunate. When it gets to be FDA approved, insurance will be forced to pay for it, but there’s no pharmaceutical company backing this clinical trial and trials are expensive.
Kara Fitzgerald: Yeah.
Tami Meraglia: It’s patient funded.
Kara Fitzgerald: Right, right, right. Well, I just, I have to say when I looked and the cost associated with your therapy, it was certainly cheaper than some of the other areas, some of the other clinics that I was looking at. Although I’m very new to this, so I’m not quite sure how to compare at all. Listen, Dr. Tami, it’s been, it’s just really been great to talk to you. I’m so excited about it. Is there anything else that I haven’t asked, given that this is really sort of a new area for me, one that I’m eager and interested in, but is there anything else you want to add? Anything I didn’t ask that clinicians or folks that would be interested in pursuing this [inaudible 00:31:25]?
Tami Meraglia: Yeah, just call me. Contact me and I would … We’re going to change the future of medicine.
Kara Fitzgerald: Yeah, got it. I hear that. Listen, how did your dad end up responding, since that’s how you started this journey?
Tami Meraglia: Amazing. He doesn’t use oxygen around the house anymore. His oxygen saturation, when he was walking previously, was in the 80’s and now it’s 95.
Kara Fitzgerald: Wow. Okay. That’s a great place for us to end. Thanks again, Tami. Folks, you’ll find all of the details to reach Dr. Meraglia. I’m sorry, Dr. Tami.
Tami Meraglia: No, no. That’s not your fault or mine. I married an Italian.
Kara Fitzgerald: I’ll grab the citations that she wants you to be aware of and you’ll find contact information for Dr. Tami. Again, thank you so much.
Tami Meraglia: Thank you.