GLORIA: I’m Gloria Campos and I’m here again with Dr. Bill Johnson at Innovations Medical.
We’re talking about stem cell deployment.
Now, we’re actually going to walk through this procedure and who actually should be interested in this.
DR. BILL: Yeah, help patients know what to expect. This is kind of a new world for a lot of people.
GLORIA: Both of your patients told me that one of them saw you on television and heard you talking about it; the other one did some research after a relative came and had a successful treatment.
Tell me a little bit, let’s start at the beginning, what kind of disorders are you seeing and treating with this stem cell therapy can I call it?
DR. BILL: Stem cell therapy.
The area that we have the very most data, the area we feel the very most confidence is in arthritis disorders – knees, hips, shoulders, elbows, wrists. We’re doing very well and evidence is really increasing. We’re learning more and more who’s not a good candidate. And so, the majority of the time, we’re seeing really nice responses.
We’re doing more and more COPD patients. Some of the COPD websites are starting to recommend this as an alternative. We’re learning more and more. We’ve had some folks with a really dramatic response, others with less dramatic response, but what’s really unique in the COPD world is, having treated for many years as an internist, there’s nothing you can offer those folks to reverse their illness and this is the first time something has been around with the potential of actually reversing their illness.
We’re doing a lot of work with neurologic disorders. We’ve probably had the most experience with neuropathies because we can deploy the cells not only IV but we can also deploy the cells locally into the area that they have a problem. And so, we’re seeing really nice responses in those folks.
We’re doing stroke patients, MS patients, ALS patients, seeing some response in those and getting better at it, I think, all the time. We’re doing some neurologic disorders like male erectile dysfunction, interstitial cystitis. We’re doing some work with patients with heart failure – that was one of our personal interests and one of the reasons I got involved in this to begin with. Again, seeing some folks that have some increased mobility, increased ability to breathe and move around from their heart failure.
GLORIA: Now, we know that stem cells have the ability, the capability of regenerating and just making duplicates of themselves. You’re harvesting these stem cells from a person’s fat which is basically through liposuction which is a very common procedure. What is the difference between the stem cells that you’re harvesting from the fat than, say, embryonic stem cells?
DR. BILL: Well, you call it “adult stem cells” because they come from an adult and they’re your stem cells because they’re from your fat. Embryonic cells are cells that have been taken from, typically, a frozen embryo – an embryo that has been derived from an in vitro fertilization. Typically, when they do that, they will harvest a large number of eggs and fertilize anywhere from ten to twelve and rarely does anyone use all ten or twelve and so there’s an estimated 35,000 to 40,000 fetuses in the United States that are frozen right now because they are in existence and mom and dad don’t want to raise any more children. And so, some of those have been historically used in small amounts because it’s very tightly controlled in the United States, so those have been used for stem cells for the individuals. That has a lot of legal and ethical ramifications. While there is some good work being done, it’s probably never going to be widespread because there are concerns about ever having a baby just to benefit yourself.
GLORIA: All right.
DR. BILL: There’s also cord blood being used. Cord blood has started becoming mentioned as a non-living, non-related. The issue with that is cord blood has only stem cells in small numbers but, also, there is a slight risk of what’s called graft-versus-host disease where, when you receive stem cells from a non-related donor, then those stem cells can come in and attack the person that receives them and so there are some concerns on that with cord blood.
GLORIA: With cord blood, there’s the possibility of…
DR. BILL: Graft-versus-host.
GLORIA: Graft-versus-host which is basically where the tissue would attack because it’s not from you.
DR. BILL: The donated tissue attacks the new host. It’s a different disorder from the host body rejecting a transplant organ. It’s the opposite; it’s the transplant organ rejecting the host.
GLORIA: Wow. So, then there’s also, obviously, we hear a lot about bone marrow transplants.
DR. BILL: Well, bone barrow are also known as hematopoietic stem cells because they come from “hemato” or blood origin.
DR. BILL: They are the leader in the United States. They’ve been around in the United States for thirty years. Everyone you’ve ever heard that had a bone marrow transplant, that was really a stem cell transplant. Now, they’re referred to as hematopoietic stem cell transplant as opposed to bone marrow transplant because it’s only stem cells that are able of producing new blood cells in the recipient.
The issue with hematopoietic is it gets many fewer cells from the harvest so, in order to have enough cells to transfer, we have to grow them out blights and that requires a bunch of regulatory things on the FDA and, really, a commercial-grade laboratory to be able to do that so it really adds to the expense of the procedure.
The other thing that is important about hematopoietic stem cells versus fat stem cells, as we age, we have fewer and fewer stem cells in our bone marrow. But, as we age, fat stem cells stay pretty constant. By the time we’re in our 40’s and up, you have to have quite a few “pokes” if you will to the bone marrow to get enough or quite a few hours to get enough peripheral blood cells and then you have to plate them out and grow them where, with fat, we can do one procedure in a couple of hours, harvest 50 ccs – which is about three tablespoons – and get anywhere from 50 to 100 million stem cells.
GLORIA: So, the stem cells found in one’s fat – your fat, my fat – are really the best candidates for helping someone?
DR. BILL: They’re the most readily available and easiest to get and easiest to use.
GLORIA: Okay. So, now we’re getting people interested in what you’ve mentioned as far as what you’re seeing results in. They’ve seen the videos. Where do they start?
DR. BILL: Well, I’d say this video is a really good start because they can understand the whole process. But, once they feel like, “Yeah, I’m interested,” they can call and meet with a consultant. The consultants are well-versed. If they wish to, they can set up an appointment to meet with me and we can talk about their disorder and make sure that they’re a good candidate.
Oftentimes, when they meet with the consultant, the consultant will get the necessary information for me to be able to review the chart and I can look over the material and let them know if you’re a good candidate because we have a lot of patients that come from out of town and even out of state. And so, it can be real helpful to know before you get in and drive or fly here that, “Yeah, this is going to be a good idea for me when it’s done.”
GLORIA: All right. There is a procedure then.
So, what are you looking for in their materials?
DR. BILL: We’re looking to see, is this a good candidate? Are they a good joint candidate? Are they a good lung candidate? Do they have a profile for one of the disorders that we know we’re having some effect and that we have an IRB protocol.
One other thing that’s real important to know is we’re working under the guidance of Investigational Review Board or IRB. The IRB looks at all the things that we’re doing and says, “Yes, that’s safe for doing to human beings,” and they give us blessings on how we do what we do. Because of that, we have some protection in the state of Texas and the state of Texas says, “You can do stem cells as long as you’re working with an IRB.” It also gives our patients some assurance that we’re not just out to make a buck or just out to take something from them. We’re actually doing legitimate research that has oversight by investigational board and we are reviewed on a regular basis. We put all of our data into a common data bank. And so, when patients come in, what they ultimately have to fit is they have to fit into one of our protocols that the IRB has set out for us.
GLORIA: And approved.
DR. BILL: And be approved. And so, we look and say, “Yeah, we can fit them under our neurologic protocol,” or, “We could fit them under our orthopedic protocols,” and, that way, we could say, “Yeah, you’re okay to do this.”
GLORIA: Okay. So, say they’re a good candidate and you’ve reviewed their information. What happens next?
DR. BILL: Well, now there’s a lot of paperwork. Anyone that’s had a surgery in a US hospital in the last two years knows there’s a whole lot of paperwork to be done and, on top of that, we have paperwork that has to do with this being investigational. So, it’ll take an hour for someone that really is going to actually read – which we highly recommend. It’ll take an hour for someone to read and go through and sign all the materials. If you want to do it here in the office, that’s fine, but you need to understand you need to be here about an hour ahead of time. It’s going to take you an hour to do the research, do the paperwork, and we really encourage you to do that.
GLORIA: And understand it.
DR. BILL: Understand it. The paperwork, yeah, there are regulatory reasons for it being it there but, ultimately, it’s there for the patient’s protection. Ultimately, it’s there so the patient really understands what’s about to happen. By signing on that, that’s what they’re acknowledging – that “I understand what’s about to happen and why it’s about to happen.”
GLORIA: And it’s patient-driven research. They are part of a research project.
DR. BILL: They are part of the research project and that’s also made clear within the paperwork.
GLORIA: All right. So, they’ve done their paperwork. You recommend doing that before you even step foot here. They can do it over the internet. Once they get here, the day of the procedure, what happens? A lot of times, they tell you, “Don’t take aspirin. Don’t do this and that.” What do you tell them?
DR. BILL: We prefer not to have aspirin but, with some of their disorders, we actually will do a harvest with patients on aspirin and we’ve done that safely.
DR. BILL: If they’re on blood-thinners or anti-coagulants, they need to let us know before they arrive. We can give them instructions on that.
DR. BILL: We’ve also found that patients with arthritis, for example, do a little bit better if they’ve been off their anti-inflammatory medications for a day or two.
GLORIA: Why is that?
DR. BILL: It looks like, when we have a little bit of inflammation – let’s talk about a knee – let’s say you’ve got a bad knee and you’re on Naproxen or an Ibuprofen for it, those drugs are anti-inflammatory and one of the things they do is they decrease the amount of growth factors in your knee that are yelling for help. So, about anywhere from two to three days beforehand, we like folks to stop those so we’d like those growth factors yelling for help because, when we put our stem cells in the knee and we put our stem cells in the vein, those growth factors call through our stem cells and encourage them to make change in the type of cells we need so that’s been one of the newer things we have learned in the past year – that having a little bit of inflammation in joints and nerves and other things helps. And so, we’d like them to stop their drugs a couple of days. They don’t have to be in horrible pain. They don’t have to be in full-blown rheumatory arthritis flare. We just need a little bit to get the job we need done.
GLORIA: And everything works better then, it sounds like.
DR. BILL: That’s right.
GLORIA: Well, like everything, once you’ve done the paperwork – which you said takes about an hour – and you know what’s going to happen – and we’ll talk about that a little bit more – what are the risks? Doing liposuction, to get your fat, it’s processed here in the office and then basically injected, say, into your knee, right here, one day, how long in time?
DR. BILL: It takes about two, two and a half hours from the moment you hit the door until the time you leave. You probably have an hour for that if you haven’t done your paperwork. We’ll take you first and do a little pre-op exam if I haven’t met you before then we’ll examine you and make sure that we are safe to do the harvest, do a little blood work, make sure we can do a little minor surgery, and then we take some pictures. Typically, we don’t medicate. It’s too comfortable so we don’t even give a sedative or a pain medicine because it’s just not necessary. We’ll take you in, we’ll do the harvest under a local and the harvest takes a whole lot less time than we’ve been talking here. It takes about five to ten minutes to do the harvest.
GLORIA: And it’s from your belly usually?
DR. BILL: We can do anywhere. We do it most often from abdomen because it’s easy. It’s easy access and most of us in the United States have some excess fat there. But we can take it from anywhere you have fat and we’ve occasionally taken it from a flank or a knee. So, there are other areas we can take it if we need to.
GLORIA: So, all of this takes about, you said about three hours.
DR. BILL: It takes about… Now, once we have the fat, we take it and first we centrifuge it to separate it out from the numbing fluid. Then, we add an enzyme called Collagenase and what it does is all of the fat cells are interconnected by strands of collagen which is a protein. The Collagenase, all it does is break down that collagen so that now the fat cells and the stem cells are all floating free. When I spin it again in a centrifuge, the fat cells are lighter than the stem cells so the stem cells all go to the bottom. Then, we wash away the Collagenase. At the end, we have a product that is commonly referred to as Stromal Vascular Fraction or SVF from the 50 ccs, three tablespoons of fat. When we’re finished, we have 50 to 100 million stem cells and a large amount of growth factors, and these growth factors are highly anti-inflammatory so a lot of the early benefit we see from deploying this comes from the growth factors turning off inflammation.
GLORIA: And that’s what we probably saw in JV, the patients that we interviewed.
DR. BILL: And folks that have an early response were convinced that that’s predominantly due to the growth factors because everything tells us it really takes about three months for stem cells to recognize where they are, turn into what we need, and grow in enough numbers to produce symptoms.
GLORIA: To heal.
DR. BILL: To heal.
GLORIA: Okay. So, what are the risks here?
DR. BILL: The risks are really minimal. You’ve got all the risks of liposuction, but it’s a small volume liposuction so, if possible, there’d be an infection, but we’ve done nationally well – probably around 2,000 cases and never had an infection. Given the typical infection rate of liposuction today, it’s very likely we’ll never see an infection.
There was one patient that was done within a network – not one of ours – that was on a blood thinner that couldn’t be stopped. It got a little blood clot in the area where they were harvesting. We’ve actually done several patients on blood thinner here and had no problems. Even then, it’s unlikely.
But you do have problems with some bruising – you usually see a little bruising, you’ll see a little swelling, and that’s realistically what most people have. Since it’s your cells, there’s really no chance of reaction so the risk of taking the stem cells and giving them back to you is quite minimal.
GLORIA: You wouldn’t be making yourself sick because it’s your own tissue.
DR. BILL: That’s correct.
GLORIA: So, benefits?
DR. BILL: The benefits are what we’re investigating and I think it’s important to say that upfront and for folks to understand that. That said, we’re seeing about 85 percent of patients respond with a resolution of pain and hips are around 75 to 80 percent, shoulders up around 95 percent so we’re doing very well. We’re doing very well with neuropathic pain. Those patients are doing very well and many of them are, as they wait, because you often see a real rapid improvement with pain but, over time, they’re also seeing a recurring of normal function of the neurons and seeing some of the numbness and deadness go away.
With COPD, we’ve seen patients, the thing that’s been most reliable is seeing patients that were spending three or four months a year in the hospital. That’s been the thing we’ve seen the most.
We’ve seen some improvement in exercise tolerance as well which is what we’re really looking for.
Erectile dysfunction has done very well. We’ve not had anyone back. Everyone responded so well with that one.
We’re doing very well with some of the other neurologic disorders. Some of them, you’ll take what you get – a stroke patient that’s had less spasticity and increased flexibility when she had a stroke, had patients with MS and ALS that have arrested their disease. With ALS even, that can be important because it’s a progressive disease and, if you’re able to stop it, that in itself is significant.
GLORIA: All right. Well, we’re talking about, you said we’re doing research here and this isn’t covered by insurance and it is a little expensive but, compared to a knee replacement, tell us a little bit about this.
DR. BILL: Well, we charge typically $5,000 for a deployment and $2,000 for repeat deployment. Typical knee replacement, total charge that everyone experiences – your insurance company, everyone – is typically around $100,000 by the time you finish rehab.
DR. BILL: Your cost on that is probably going to be more than $5,000 on your deductibles and co-pays and that sort of thing. From a cost standpoint, it is still a very reasonable way and, from a savings on pain and discomfort standpoint, a pretty significant improvement.
GLORIA: And, really, because the research is kind of preliminary at this point, you don’t know how long it might last. You can’t empirically say…
DR. BILL: We’ve had people that are five years out and still doing well. But we really can’t speak much beyond the five-year window because there’s no one out there beyond five years.
GLORIA: Wow. But this is really, really giving people not only hope but giving their lives back.
DR. BILL: Yeah, on the joint pains, we really can’t say that and folks with some of the inflammatory arthritis, rheumatory arthritis are saying they’re really making a big difference. So, in the other disorders, we’re making some difference in areas that you couldn’t make any difference before.
GLORIA: At all.
DR. BILL: At all. And so, while it may not be everything we want, we’re getting better all the time and we’re talking about disorders that, prior to now, you couldn’t do anything for.
GLORIA: So, you have the deployment, you’ve walked through, you’ve harvested the fat, you reduced it down to the stem cells; after the deployment, what can the patient expect?
DR. BILL: Well, with the majority of patients, it depends somewhat on the disorder. But the typical knee, for example, most of those patients see a very early response in a day or two and that tends to get better for three to four weeks and then plateau. We believe that’s all due to the growth factors.
Now, over a few weeks, some of those patients will get worse, but most of our patients have plateaued and then, in about three months, start seeing an ongoing improvement and we believe that second slope of improvement is the stem cells finally growing in enough numbers to make a difference.
GLORIA: When you say growing in enough numbers, they have basically repaired?
DR. BILL: They’re starting to do their repairing and will continue to do that for several months to a year.
GLORIA: Wow. And that’s after the deployment of the stem cells.
DR. BILL: After the deployment of the stem cells.
GLORIA: So, I guess you would recommend anyone to check these videos, right? Carefully. But you’re always readily available.
DR. BILL: Readily available. Alan Vojtech is my assistant. Alan does all these consults. He’s always up-to-date on this and we’re readily available and Kim is an excellent source for patients to get questions answered.
GLORIA: We also have some videos about patients that have undergone the procedures and are very pleased with the results.
DR. BILL: They can take a look and see and get some understanding of what this is like.
GLORIA: And they are very happy, I can say that for a fact.
Thanks a lot for your time, Dr. Johnson.
DR. BILL: Thank you.
GLORIA: Appreciate it.
Email us at email@example.com with any questions that you may have or if you want to know what special offers that Innovations Medical may have regarding stem cell therapy. Contact our Dallas branch at 214-420-7970.