New York Times reports 3 patients going blind after stem cells.
Dr.Kondrot responds, “You need to be careful and select the right doctor, right type of stem cell and the right delivery method or you will be at a grave risk!”
This evening, we’re going to talk about a serious event that occurred in Florida. I was shocked when I read the article in The New York Times Magazine. The article is “Patients Lose Sight After Stem Cells are Injected Into Their Eyes.” The article dealt with three patients who had received stem cells in a facility in Florida.
Listen to the recording of the show!
First of all, I was shocked because I am doing stem cells for the eye. I am really concerned because this article is bad press to a procedure that can help many individuals. There was a problem with this study. There was a problem with how these stem cells were administered. I’d like to give you my opinion.
First, these stem cells were autologous stem cells from the fat tissue. There are many different ways of obtaining stem cells. Autologous stem cells are probably the most common. They are obtained from the patient’s bone marrow or abdominal fat. They’re processed, and then they’re injected into the tissue or bloodstream to put back into the person. There are a couple of problems with this. If you’re in your 70s or 80s and they’re taking stem cells from your body, these are going to be old stem cells, and they may not have much in the way of regenerative properties.
Another type of stem cell is called cord or placenta. These are cells obtained from the placenta or cord of a newborn baby. They are extremely potent stem cells. Some people estimate that they may be a thousand times more potent. You can see that the type of stem cells is something to consider when receiving stem cells for any condition.
The problem that may have occurred at this facility where these three people were blinded was the processing of the stem cells. Taking the abdominal cell and not processing probably can leave toxic material in them.
Later on in the show, we’ll have Dr. David Steenblock who is an authority on stem cells. As a matter of fact, he’s the author of a book about cord stem cells. He’ll be joining me at the bottom of the hour.
Another problem is the training in this facility. These were not ophthalmologists or eye surgeons that administered them to the eye. In fact, the article stated that a nurse practitioner injected them into the eye. That is important. You should have someone highly qualified, trained, and knowledgeable with that particular area that the stem cells are being administered.
It’s common sense that if you’re dealing with the eye, you should have an eye surgeon or eye doctor administer these cells, not a nurse practitioner, GP, or internist. I am an expert when it comes to the eye, but if I’m going to be injecting stem cells into the spine or knee, I probably don’t have any business doing that. I’m not knowledgeable with the anatomy, and I don’t have any experience.
The last issue is the way these stem cells were injected. I am using two methods for introducing stem cells into the body. One is intravenous, which I feel is the safest. It goes into the bloodstream, circulates in the body, and is slowly absorbed. The second way is retrobulbar. This is an injection that goes under the eye, not into the eye. It’s in an area very close the macula and optic nerve.
In this situation, I’m not sure if the stem cells were intentionally injected into the eye or inadvertently in the course of a retrobulbar injection they got into the eye. Either way, it was a tragic event.
In some situations, eye doctors will inject stem cells into the eye, but it should be done under supervision, and the doctor should be highly qualified. I am not injecting stem cells directly into the eye because of my concern of an increased risk of infection or complications. As a physician, our number-one oath states that we shall do no harm to the patient. It is rather tragic that this event occurred, and I think it brings up several important lessons for those of you who might be considering stem cells not only for your eye but for any other part of your body.
I have produced a webinar event which goes over in detail all aspects of stem cells for eye disease. You can go to www.EyeStemCell.org. This is a comprehensive webinar that goes over in detail several key things: timing of stem cells, the best stem cells, the best candidate for stem cells, who should be delivering the stem cells, and many other aspects you need to know not only if you’re considering stem cells for your eye but for any other part of your body.
I have come up with a mnemonic. I am going to be talking about each one of these during the course of the radio show. The mnemonic is STEM CELL.
S stands for the selection of the stem cells. By that, I mean the type of stem cells.
T is the timing. We’re going to talk about that in a little bit more detail. The timing is important because if you have a lung infection or sinus infection and you receive stem cells, they are going to take care of that infection and not take care of the part of the body you may want to be treated.
E is education. I’m talking about education of the doctor. Are they trained in administering stem cells? Do they specialize in that particular area?
M is the method of injection. We’ll talk about the different types of methods.
C is continued growth. What can we do to keep those stem cells growing in the body?
E is extracellular nutrients. It’s like a farmer when he buys expensive seeds. He needs to have good, rich soil, water, and sunlight for those seeds to grow. It’s very similar to stem cells in the body. You need to have the nutrients.
L stands for light. We’re going to talk about light therapy that has been shown to stimulate stem cells.
L stands for low-level microcurrent. Believe it or not, frequencies have been patented that have been shown to stimulate the growth of stem cells and help release certain factors to keep those stem cells growing.
If you just joined us, we’re talking about the tragedy that occurred in Florida with three patients who went blind after stem cells. This should not have happened. Later on, we’re going to have some experts joining us to talk about this complication. If you want more information, go to www.EyeStemCell.org.
We’re coming up to a break. We’ll be right back. You’re listening to “Healthy Vision.”
Welcome back to “Healthy Vision.” This is your host, Dr. Edward Kondrot. We’re talking about stem cells and risks that you should be aware of. With me is Mike Basich, a representative of a stem cell manufacturing company. Mike, it’s great to have you on “Healthy Vision.”
Mike: Thank you for having me.
Dr. Kondrot: It’s a tragedy that occurred with those three folks in Florida. It’s a tragedy that should not have occurred. It’s very upsetting to me, and I want to get your opinion on how this could have been prevented. What is your take on it?
Mike: You couldn’t be more right. It is tragedy. I don’t know all the ins and outs of how it might have been presented. One thing I can say for sure is that if the individuals who were treating these folks would have followed the same guidelines that the company I represent follows, the FDA guidelines, this would never have occurred.
Dr. Kondrot: What are the FDA guidelines?
Mike: The FDA guidelines for autologous cells, because these were from their own body, are that they need to be clean and tested. They need to be administered by a licensed physician. The article I read indicated that none of those things occurred. It’s an unfortunate tragedy. My understanding is that a nurse practitioner administered these cells, there were contaminants in them, and they were the wrong cells to use in that application. That was my understanding from the article.
Dr. Kondrot: This is really unfortunate because the day that study came out, I had several people in my office ready to receive stem cells. I had to explain that we do not use stem cells from the fat. We do not process that. Any time a physician prepares stem cells in his office, there’s always a risk of contamination and other issues which may develop.
One of the reasons I use BioBurst is that your company is an FDA-monitored company. You only use cord stem cells. There’s a strict processing quality control. Maybe you could talk about the requirements your company has in order to deliver these stem cells.
Mike: We have to follow FDA guidelines. For screening, it’s for disease, bioburden, and drugs or chemicals of any kind of that nature.
Dr. Kondrot: That’s a good point. One of the concerns all my patients have is, “How do I know this is a healthy baby? How do I know the mother doesn’t have some heredity disease that might be transferred to me?” You really investigate this.
Mike: We investigate it very thoroughly. These cells are homologous. They are taken from a donor and given to a recipient. In our particular instance, the red blood cells and the Class 1 and Class 2 antigens are removed, so they are considered DNA neutral and immune privileged. There’s no chance of DNA material being passed along there.
In addition to that, there’s also a process at a CLIA-approved lab, which is an FDA-certified laboratory. Our company as a whole is monitored on a regular basis by the FDA. There are very strict guidelines we must follow to process these cells.
Dr. Kondrot: What advice do you give to patients? The marketplace is very confusing. Everyone is advertising stem cells. It upsets me because people think a stem cell injection or delivery is going to be an instant cure. It’s not. It’s just a way to help strengthen the body to help the body utilize its own regenerative properties. It’s not a miracle. You have to do so much more before and after you receive stems to make sure they work.
Mike: What most people don’t realize is the reason stem cells are so effective is because they are uncompleted cells. They have yet to finalize and ultimately become the cells they will become. Multipotent cells, the safe cells that are FDA approved, can only become one of the six major body types: bone, cartilage, nerve, vasculature, and these types of things.
The body of the recipient is sending off signals that these cells respond to, to help the regenerative process in their body. That process is different for each person. That response is different for each person because the need is different from person to person. Some folks have one disease or injury they’re battling. Other people have multiple things.
The cells come into an environment where they’re responding to these requests that are made to them at a cellular level. While it would be awesome if we could guarantee that this or that would be healed or that another function would happen, that’s not the way the body works. They respond to the signals they are given, and they work that out within the recipient’s own body.
Dr. Kondrot: One of the biggest problems we have is directing the stem cells to the particular tissue where we want to have the maximum effect. That’s one of the reasons I’m using microcurrent and light therapy. The thought is that the light and microcurrent will help guide those cells to the retina or optic nerve when you’re administering microcurrent. I’m working with a company called EyeCell out in California that has patented some frequencies that help produce stem cell derivative factors that help the stem cells replicate and grow in a directional signal. It helps guide them.
Your company produces only cord stem cells, which are much more potent than autologous. I mentioned earlier that if you’re 70 or 80, you bought 70 or 80 autologous cells. There’s nothing you can do about it. They’re older. The telomeres are shorter. The stem cells have less ability to generate. That’s probably part of the reason why when you’re in your 80s and you get a cut, it takes a little bit longer to heal. If you’re unhealthy or sick and your stem cells are sick, it may not heal at all.
There is a purpose and a place for autologous. They work remarkably well in the treatment of joints and some musculoskeletal problems. When you’re dealing with a more serious issue like vision loss, you probably want the most potent stem cells available to help.
I’m grateful your company did get FDA approval. I don’t want to mislead people out there. It’s not FDA approved for the treatment of eye problems. It’s just the cells are approved to be used under the physician’s discretion. Correct?
Mike: That is one of the most important points. I was about to make the point that one of things I think went wrong with this unfortunate thing that happened with this stem cell clinic in Florida is that the FDA licensure for homologous cells is as determined to be homologous by the treating physician. At least from the article I read, one of the issues was that the physician was either not treating or involved in it or was missing in that process at some point in time.
That struck me just in that moment as you described those treatments. That’s one of the things that are most important. You as the physician need to be the one making those decisions that, “Yes, these cells are required for these reasons. We want to help them along with this treatment or another treatment,” or whatever else you do to maximize those. That’s the responsibility and expertise you’re bringing to the table as the physician. That’s part of why the FDA has given the licensure to these cells. It’s with the understanding that the physician is making that decision.
Dr. Kondrot: Right. In this particular case, it could have been in the processing of the cells. It’s really an unfortunate event that occurred. Part of me feels that there should be more regulation. On the other hand, any time there’s more regulation, it will drive up the cost. It will be less affordable and less available for patients.
We’re coming up to a break. Mike, I want to thank you so much for joining us and giving us your opinion as a manufacture. We’ll be right back with “Healthy Vision.”
Dr. Kondrot: Welcome back to “Healthy Vision.” We’re talking about stem cells and that tragedy can happen if you have them administered in the wrong way or by the wrong person. With me now is Dr. David Steenblock who is considered one of the leading authorities on stem cells. In fact, he wrote the book on cord stem cells. Dr. Steenblock, it’s good to have you on the radio.
Dr. Steenblock: It’s nice to be here. Thank you.
Dr. Kondrot: When you read The New York Times article about stem cells and blindness in Florida, you probably said, “Kondrot is probably up to no good.” Tell me the truth.
Dr. Steenblock: Any time we have a new profession, a whole new way of doing things, there’s always going to be some troubles. Those three cases and the few cases we’ve had with the use of autologous stem cells compared to all the problems we have with drugs on a daily basis is absolutely miniscule when you compare to the drug problems and drug deaths we have in this country that are FDA approved. It’s quite interesting to see how the public relations people and the media really held this up as a terrible thing, yet we don’t hear much of anybody dying every day from drugs, drug overdoses, and side effects.
Dr. Kondrot: You’ve been doing stem cells for 10 years or longer.
Dr. Steenblock: It’s since about 2000.
Dr. Kondrot: In your vast experience, this should not have happened. What is your take on this?
Dr. Steenblock: Obviously, these people were not trained well and did not do the procedures well. They were not even doctors, and they put injections of these stem cells into these peoples’ eyes. They didn’t check for things like bacteria, yeast, particulate matter, and all that.
They were taking fat and using a certain enzyme called collagenase. They digest that together and separate the stem cells out of that mixture. The trouble is the separation has to be done correctly. If you don’t check on it, you can wind up with a lot of particulates in that soup you get from processing the fat. When they inject that directly into the eye, it will clog up the eye and the trabecular channels in the eye. Then the enzyme can digest the retina too.
It could have been one or both of those things that caused these problems, but it was all down to the fact that these people were not trained, didn’t know what they were doing, and were not even doctors.
You can rant and rave about how we need more rules, but there are no rules in the world that will stop people who are crazy and stupid from doing things without thinking about it and getting people in trouble because they don’t know what they’re doing. No laws will protect people from that. You, yourself, have to look at everybody you’re working with and decide whether these people are talented, trained, and have good experience and whether you trust them to do the job.
Dr. Kondrot: Ultimately, it’s the physician’s responsibility. It’s easy to blame it on a lab or something like that.
One of the things that concerns me and I think the public in general is that there seems to be a lot of hype concerning stem cells. People think it’s a miracle instant cure. A lot of physicians are quickly getting into this business of overselling stem cells. They’re poorly trained, and there are going to be problems.
Dr. Steenblock: There’s no question about that. In general, the whole fat stem cell industry is overhyped and under regulated. The people who are doing it really don’t have the training, education, and experience to be involved with it. I’m rather pessimistic about that whole group. The FDA has been trying to come up with rules and regulations. I don’t know what they’re going to come up with, but they should have some way to make sure the people who are doing fat stem cells have some kind of training.
I was looking at a website offering a five-day course on stem cells for $600 or $700 to learn how to do all this stuff. In three or four days, you don’t learn things like microscopy. Microscopy takes weeks and months of sitting at a microscope assessing things and understanding differences between small nuances. These people are not trained. They don’t even know how to turn a microscope on. They don’t even have one.
When you’re dealing with cells, which are microscopic, you want to know whether or not those cells are pure. The only way to know that is to look at these cells with a microscope and know what you’re looking at. These people just don’t know.
Dr. Kondrot: In case folks are interested in finding out more about you, you have an extremely reputable center in California. You’ve written one book. Do you have a second book now?
Dr. Steenblock: I have one book out about chlorella, single cell wall algae, as a nutritional supplement. It is an immune stimulant and detoxifying agent. Then I have my umbilical cord book. Now I’m just publishing articles. I just published a bunch of articles in Townsend Letter about amyotrophic lateral sclerosis, the cause of amyotrophic lateral sclerosis, and how to go about treating it. My focus right now is neurological cases more so than anything else, but I do general work with stem cells.
You talk about miracles. There was a book published in 1987 about hyperbaric oxygen. They call that book Hyperbaric Oxygen: The Uncertain Miracle because hyperbaric is the same way. You get results most of the time, but not all the time, so you can’t really promise anybody that you’re going to always get good results. The reasons for that are many.
I bring out in a lot of my writings what you have to do to avoid having failure with stem cells and things like infections you don’t know about. Those are causes of it. Drinking alcohol, exposure to toxins, and trauma are other causes. There are all these different factors that can block the effect of the stem cells. Your doctor who’s working with you should evaluate these things carefully and make sure you don’t have these things to deal with when you have your stem cells. Otherwise, you do have failure. Sleep apnea and lack of oxygen at night is another factor.
Dr. Kondrot: When I was at your center a few years ago, I hung out with you learning some of these tricks. You take very seriously getting the patient ready, getting rid of infections, and improving the oxygenation and circulation. I think that is essential.
Dr. Steenblock: Being an ophthalmologist, I’m sure you’re aware of the fact that the fovea, the center area of the macula that causes us to be able to look at something carefully and see the sharp outlines of your face when we’re looking at it, is the most oxygen-dependent and oxygen-utilizing tissue in your body.
If that tissue doesn’t get enough oxygen, that doesn’t work. It says to the surrounding tissue, “We need more blood vessels.” Then the eye starts to make more blood vessels. The process of making blood vessels in these patients becomes intermittent. The intermittency of capillary growth causes poor blood supply to the eye, and you wind up with macular degeneration. If you check for oxygen at night and they have lack of oxygen, put them on oxygen. Often you can stop the macular degeneration very quickly because you have them oxygenating. They no longer have to make these poor blood vessels to try to bring oxygen to the fovea.
Dr. Kondrot: That’s one of the reasons the hyperbaric oxygen, oxidative treatments like ozone, and even good old-fashioned exercise will improve the oxygen to the back of the eye, which is unheard of right now.
Dr. Steenblock: One of my cases did hyperbaric oxygen and external counterpulsation. She was a legally blind lady about 65 years old. By the time she finished six weeks later, we did a video of her threading a needle with her bare eyes. She had no glasses or anything, and she was threading a needle.
Dr. Kondrot: Give the listeners your website and the best number to call.
Dr. Steenblock: My website is www.StemCellMD.org. My phone number is (800) 300-1063.
Dr. Kondrot: Thank you so much for taking time to clarify your insights on this tragic event that occurred in Florida. Thank you so much.
Dr. Steenblock: Surely.
Dr. Kondrot: We’re coming up to another break. I will return with more information after this break.
Welcome back to “Healthy Vision.” This is Dr. Kondrot. We’re talking about the tragedy that occurred in Florida with three patients who lost their sight after stem cells were injected into their eyes. This is not supposed to happen. Stem cells are supposed to help your vision, not cause blindness. I appreciate Michael Basich and Dr. Steenblock joining me on the show to give their insight into this.
I’d like to summarize the problem. First is the selection of stem cells. I think it’s really important you are certain you have the highest quality stem cells. How are they produced? We mentioned that autologous stem cells taken from your body may not be processed properly. There could be contaminants, fungi, mold, or other toxic elements that can cause great harm if injected into your body.
I’m a big advocate of utilizing cord stem cells. These are cells taken from the placenta and cord of a newborn. I work exclusively with a company that is monitored by the FDA, so we know we’re getting quality cells that come from a very good donor source. That is critical.
The second thing is timing of the injection. Dr. David Steenblock mentioned having a serious infection, like a sinus infection. Who buys expensive seeds and throws them on barren soil without water, nutrients, or sunlight? They’re not going to grow. If you are receiving stem cells and investing in these potentially amazing cellular elements that can help with rejuvenation, you want to make sure your body is in top physical condition.
Third, what is the education of the doctor? Hopefully, it’s a doctor administering it and not a nurse practitioner or technician. Has the doctor just taken an evening course? Did he just read a book? What is his training?
Also, what is the doctor’s specialty? If you’re getting stem cells from your eye, make sure that doctor is an eye surgeon or trained ophthalmologist. They know the anatomy of the eye. They know eye disease. Being a board-certified ophthalmologist, I know the eye. If someone asked me to inject stem cells for their joint or back, I could probably do it but I’m not going to do a good job, and I may get into trouble. I would probably not do it because my expertise is in another area. You want to make sure about the doctor’s education and their specialty.
You want to know the method of delivery. How are these stem cells delivered? When it comes to eye disease, there is a national study underway called the SCOTS study, Stem Cell Ophthalmic Treatment Study. In this study, they are administering the cells in three ways. One way is intravenously, which I believe is the safest way. The second way is retrobulbar where it is injected under the eye. It’s not into the eye but under the eye near the macula or optic nerve. The third way is that the cells are injected into the eye, which is a risky procedure. It subjects the eye to infection and increased pressure.
I currently avoid injecting the cells into the eye. I prefer intravenous and retrobulbar. That’s under the eye near the macular, not into the eye. As a physician, I think our number-one mission is to do no harm to the patient. We should avoid a risky procedure.
An analysis written by a surgeon from Bascom Palmer stated that if you are injecting them into the eye, you should never do two eyes at once. Unfortunately, one of the patients that lost her vision had these stem cells injected in both eyes. That should have never happened.
You also need ways to help these stem cells with continued growth. By that, I mean the patient should be advised on having the body in maximum health and avoiding toxic food. Dr. Steenblock stated that alcohol can interfere with stem cell activity, so you want to avoid alcohol before and after. A glass of wine probably isn’t going to hurt, but you want to avoid high levels of alcohol.
You want to avoid toxins in the body such as heavy metals. If your heavy metals are off the chart and you have mercury and lead, don’t get stem cells. Wait and detoxify before you get the stem cells.
You need to investigate other methods to get these stem cells to grow. There have been several good studies showing that light therapy and low-level microcurrent can help stimulate existing stem cells. These modalities can stimulate your existing stem cells.
We have stem cells in our body already, but as you get older, those stem cells get a little bit weaker. We need ways to get them stimulated, and light therapy can help. There are several different light frequencies we use in our office, including a cold laser, an infrared light that helps. Low-level microcurrent can be phenomenal. There have been frequencies patented to stimulate stem cell derivative factors that have helped stem cells grow and go to the area where they’re needed.
I feel so strongly about microcurrent that when you receive stem cells at my clinic, we give you a microcurrent machine to use. It is essential to get those stem cells growing and multiplying and help direct those stem cells to the particular area where they need to do their work.
I put together a webinar at www.EyeStemCell.org. Listen to the webinar, and you’ll get all the information you need to make the right decision. In addition, if you are interested in more information on microcurrent, light therapy, or a consultation with me, you can reach me at my main office at (800) 430-9328. You can talk to folks at the office who will educate you on some of the services we do.
It was rather unfortunate this event occurred, but I think everybody I talked to feels this should have been avoided if all these precautions were taken where the doctors were properly trained and used the correct stem cells, and if the right person administered the stem cells.
I hope this report doesn’t put a lot of fear in patients. Stem cells can be an extremely viable treatment to help you regain your health and vision. I also have to emphasize that it is not a miracle treatment. It is not going to be an instant reversal of vision or an instant cure.
You really need to do all the other things the guests spoke about this evening. You need to look at getting your body health, eating the right food, and avoiding genetically modified food and food that’s been processed with preservatives. These foods are toxic, and you need to take the best nutrients so that when you do receive the stem cells, they’re going to grow.
You have to make sure you have the right vitamins and minerals in your body. You need to make sure you’re properly hydrated. You need to be tested for heavy metals. It’s a simple test. Get it done. You need to find ways to improve oxygenation, like exercise. Dr. Steenblock mentioned if you do have sleep apnea, you need to get a CPAP machine and improve your oxygenation at night. All these things are critical.
I have to joke with patients sometimes that if you do a lot of these things, you may not need stem cells, but if you’re going to be receiving stem cells, do these things.
All of these are outlined in my book, 10 Essentials to Save Your Sight. You can download a free copy of the book at www.KondrotBook.com.