It's 2:30 in the afternoon in the Dominican Republic, and Karen Velline, a 66-year-old grandmother from Cold Spring, Minnesota, is lying on an operating table, swaddled in sterile surgical sheets. She's just moments away from a procedure so experimental that no doctor will perform it on U.S. soil. Yet she calmly stares up at the ceiling, more excited than anxious. Despite the controversy surrounding it, Velline believes that this procedure—which she has paid Regenocyte Therapeutic, a stem-cell company in Bonita Springs, Florida, $64,000 in cash to perform—could save her from a debilitating lung condition. After months of anticipation and planning, she's ready for things to get under way.
Cardiologist Hector Rosario nods to his team and begins inserting a clear, narrow tube into a vein in Velline's leg, slowly threading it all the way up to the right side of her heart. "That's the catheter," whispers medical supervisor Leonel Liriano, who has agreed to let me watch the surgery. I can see the tube moving on an x-ray imaging screen, inching closer to its final destination, the branched pulmonary arteries that supply blood to her lungs. With the catheter in place, Rosario reaches for a syringe filled with a solution of Velline's own stem cells: the $64,000 potion. He inserts it into the catheter and depresses the plunger. A subsequent injection of saline serves as a chaser, ensuring that the cells migrate all the way to the lung vessels.
If the technique works as advertised, the cells—hand-couriered on a plane from Israel, where they were mixed with platelet growth factor to make them multiply, and delivered minutes ago to the operating room—will grow into the delicate gas-exchange regions of the lungs. Over several months, they should regenerate failing tissues that have been ravaged by Velline's hypersensitivity pneumonitis, a degenerative lung disease caused by an allergic reaction to dust and chemicals that has left her dependent on three liters of oxygen a day. Doctors at the Mayo Clinic in Minnesota told her that the only hope of reversing her condition was a lung transplant, a high-risk procedure with a drawn-out recovery period. "That was something I didn't want to consider," she says.
Regenocyte presented an enticing alternative. Its glossy brochures and the effusive patient testimonials on its Web site offered hope that stem-cell therapy could not only keep her condition from getting worse but return her to her old self. If regenerative stem cells could help others, Velline reasoned, why couldn't they help her too? As far as she was concerned, waiting years for the government to put its official seal of approval on the procedure wasn't an option. She was dying.
Every year, hundreds of desperately ill Americans like Velline are making similar decisions, sidestepping government regulations and heading overseas to access a smorgasbord of stem-cell therapies unavailable in the U.S. Many of these treatments—offered by companies like Regenocyte, Germany's XCell-Center and China's Beike Biotechnology—involve autologous adult stem cells, meaning stem cells harvested from your own blood or bone marrow. These are thought to be safer than stem cells drawn from other donors or harvested from embryos, because they incur fewer risks of rejection or tumor formation. Just how safe, though, no one knows precisely, which is why the U.S. Food and Drug Administration insists on stringent regulations.
I think that these kind of grey area procedures are OK for those people with really life threatening diseases, but they do so at their own risk. If someone want to do something that isnt really needed, like regrowing a tooth or something, then they should go into it knowing that it isnt approved.
I understand that because this is a new field of medical research and treatment that we should be careful but I do think it would be wise to take into consideration the true scope of the possible benefits of stem cells treatment. Basically stem cells can be used is such a wide variety of treatments its not even funny. Not to mention that they can also grown complete new organs should you ever need one. I'm not sure if any of you have ever seen the amazing work Dr. Atala has complied in the field of stem cell research but he has been at the forefront basically since the beginning. His team has even been able to regrow complex living tissues such as the ones found in the human heart. It's pretty trippy to see a heart beating in a test tube! I'll post a link to video if you would like to check out some of his work. Stem cell research is obviously the medical technology of the future and the U.S. better not wait much longer or we might just miss the boat which could cost us countless millions of dollars.
I think the best thing that can be done for stem cell treatments is start making the cells from the patient's fat cells. It'd help rejection too to have matching DNA; rejection is not a non issue in stem cell treatments. And the most important reason is that it'd help with the ethical dilemma of embryonic stem cells. That said, I think that most politicians if not all would endorse stem cells research if the stem cells were made from fat cells.
It's unfortunate that reality disagrees with you. As noted in the above article, the stem cells in question for these treatments *are* harvested from the patient.
The question is -- is this a safe and effective treatment?
Without some sort of an approval process, it's awfully difficult to determine. Yes, that means delays, but otherwise we end up back in the days when they were selling radium as a 'cure and energizer'.
I can see the FDA's point in classifying these types of stem cells as 'drugs'. They are clearly significantly altered before being returned to the patient.
Also, if the FDA ignored them, there would be media frenzy after the first death ('FDA Ignores Risky Stem Cell Treatment')
Not to say that it's the same thing, but Rock Hudson died after travelling to Mexico for an AIDS cure that had much of the same hype and testamonial 'evidence'.
Why is the U.S. govt reluctant? Really? Who are the invested parties? Just asking...
There is so much misinformation out there its not even funny. There is consensus amongst top peer reviewed stem- cell researchers that these kind of treatments in everything but bone marrow are at least 5-10 years away. If there was direct and promising data in animal models that such a treatment would work it would be showered with funding and brought to the national scientific spotlight. Companies would trip over themselves trying to turn it into a viable way to treat humans and funding for clinical trials wouldnt be an issue.
Why hasnt that happened?
Because the science underlying these therapies isnt there. The idea that you can drop stem cells on cancer cells/damaged tissue for a cure is one of the biggest scams out there. The doctor in this story is charging 70K plus for a treatment that he knows science doesnt support and POPSCI is giving him free publicity. This article cites a sensationalist 60 minutes piece about the marval of stem cell treatments, but fails to mention another piece were they expose what a croc out of country stem cell treatments are. The doctor in this story may as well be selling snake oil. Deplorable is the right word for the practice.
As a person with a Spinal cord injury I've heard all about this. I know a few people who travelled all the way to somewhere in China. These clinics play on people's heartstrings. While stem cells can do no harm the biggest problem is targeting the celss that need repairing. As it stands the stem cells go in and randomly start repairing whatever. It's a crapshoot. You could spend $500,000 on litres of stem cells only for them to fix your liver because you drank too much the night before.
With spinal cord injury it looks like stem cells will eventually be ONE of the answers but not THE answer. A hybrid gel/cell injection looks promising but first the genius Neurosurgeons have to laser off the scar tissue and when injecting make sure there is no increased pressure on the cord or else......back to square one.
It is becoming increasingly obvious that the FDA is beholden to the pharmaceutical industry. This is done under the guise of "consumer protection."
“I may not have gone where I intended to go, but I think I ended up where I needed to be”
I am so grateful that I was open to be educated about ASCT for my lungs. I am alive because of Dr Grekos and Regenocyte. I travel, swim, play with GrandChildren. No Oxygen any more!!!! Get EDUCATED about something before guessing it is a scam.No scam here-just more good life!!!!
I am Howard Lindeman one of the people out here that Adult Stem Cells has not only changed but saved my life.
My Doctor performed this procedure on me approx. 21 months ago.
The fact that the FDA has not approved this procedure at this time is an area of hugh debate. I have gone through an amazing metamorphosis during this past year,
I AM back to the person I was prior to my heart attack in 1989 and years of health problems since then.
I am back to a normal life both at work and at play.
Please, before you post a blog saying it doesnt work or its a scam and say there are negatives about this procedure. I can tell you I am at work again in the music business, on the road at least 250 days a year working an easy 15-18 hours a day under high stress. I am also SCUBA diving, swimming, running, walking and LIVING again which I thought was gone forever.
Life is GREAT AGAIN because of Adult Stem Cells and because of Dr. Greckos, he did save my life.
My name is LouAnn Rest. I had adult stem cell therapy in the Dominican Republic on Sept. 28,2009. Life is so good since having my procedure. My heart had an EF20 before stem cell therapy and now it is EF43 at rest and EF46 with exercise.
I am now able to play with my grandchildren. To be able to pick them up for the first time since they were infants. I am living life now and not watching it past me from the sidelines. Life is good.
Dr. Greckos has given me my life back. I am so thankful to him and everyone that made it possible for me to receive my therapy.
With cardiomapathy and congestive heart failure the only real hope there was for me was to have a transplant at some time. Now I don't see myself needing that in the future. I am better than I was twenty five years ago.
Loving life thanks to stem cell therapy,
My sister, Lou Ann Rest was diagnosed in 1986 with cardiomyopathy. We were all tested for this disease after our younger sister died of this illness and Lou Ann was found to have this disease. Over the years I have watched her deteriorate until she was so ill the only treatment being offered was a heart transplant, which is not without its' own risks and expense. She attended a workshop offered by Dr. Grekos in the area where she lives and decided this was worth pursuing before going through a transplant. Because it is not accepted in this country, it is of course not covered by insurance. I find many people cite the expense of this procedure to be 'proof' adult stem cell therapy is a scam playing on vulnerable and desperate people. If it is not covered by insurance many medical procedures are very costly. We held fund raisers to raise the funds for Lou Ann to have the ability to go to the Dominican Republic and receive her own stem cells into her heart. At the time she had her treatment she was at high risk of sudden death. As she states in her comment, her EF was 20. The last time I saw her prior to receiving her treatment she couldn't walk without being short of breath. Her ability to do simple tasks no longer was able to be done. I saw my sister so ill and I began to prepare myself as much as I could prepare for it ~ to lose yet another sister to the disease of cardiomyopathy. Lou Ann went to the Dominican Republic and received her stem cells. The first thing I noticed when she returned home was her ability to speak on the phone again for more than a few moments and she did not choke and have to end the call. The first time I was able to see her a few months after her treatment she looked like a new person. Her coloring was better, she was able to walk without exhaustion and she had energy. Her EF of 20 is a thing of the past. Her EF43 is better than it was 25 years ago when she was first diagnosed with cardiomyopathy. Dr. Grekos saved my sister and gave her back her life. Now those of us who love her have to move past the worries we have created with since she was so ill and not seek to stop her from doing things out of fear she will die. Now we remind ourselves she can do the things she once did and will not die doing them. The fact that this therapy is not accepted in America is a matter of shame to me and to many people. Research in other countries was done and this procedure has been shown time and time again to have many positive results. I am so very grateful to Dr. Grekos for the work he has done and for all he seeks to do. He gave my sister life.
I have witnessed the results of the ADULT STEM CELL treatment that Dr. Grekos provides and is as close to a miracle on this earth.
I have a very dear friend that has had her quality of life resorted after the stem cell treatment for cardiomyopathy.
I met her almost 4 years ago and was shocked at her condition and how little she could do without becoming exhausted and very out of breath,I was wondering how long we'd be neighbors before something happened to her heart and she wouldn't survive.
Happily she had the ADULT STEM CELL treatment and since having it last September the change has been unbelievable.
Her color is normal she has so much more energy,is able to dance,exercise and any other activity our group of friends take on.
The whole neighborhood sees her out several times a day walking several miles to exercise herself and her new 4 legged friend Harley the dog.
Dr. Grekos is doing wonderful things and I'm so blessed he has helped my friend,she is an inspiration to all of us.
I believe one of the reasons this isn't being pushed in the United States is due to the big drug companies and medical community,due to the less invasive procedure and lack of a need for rejection drugs after a heart transplant.
I find it suspicious that in the last day 4 people wrote in praising Dr. Grekos- its almost as if he contacted his patients about it or wrote them himself. Im am not a hater, but I am a scientist- and as such I hold large amount of skepticism over claimed medical miracles. Why are the same types of procedures performed by Dr. Grekos with human stem cell lines unviable when performed in animal models? Why hasnt Dr. Grekos turned over his data to major research institutions for further study/funding? Why do our nations most esteemed medical researchers have such strong words against Dr. Grekos's practice and procedure? If Dr. Grekos is legitimate, he opperates amongst a sea of frauds and scammers. He isnt doing anything to legitimize himself or place his procedure onto any kind of approval track. There is a lot of evidence that his procedure is bullshit, and no published scientific defense in his favor.
Dr Grekos will quickly become your best ally and probably only chance of REVERSING your heart or lung disease if you have the misfortune of developing it. The fact that you are a scientist and yet have to ask the question why human cell lines do not work in animals makes me wonder where the bullshit really lies. If you are in fact a scientist, then you understand the tediousness of compiling and interpreting and presenting data and for what? Praise recognition? AAHHH yes research grants!!! well that's the point, Grekos is an interventional cardiologist not a scientist or researcher and is therefore in the healing business.
So, when your cardiologist has run out of drugs or surgery that can help you in his "bag of tricks"....you will be calling Grekos just as I did for my son who at 9 years old, was diagnosed with a very rare lung disease and hole in his heart. I was told he would need a heart and lung transplant in 5 years. His chances of his body accepting both organs were slim and if he did, it would only buy him another 5 years. Barely enough time to kiss his first girlfriend.
Doctors at a major research university hospital sent him home with a prescription of Viagra and said they could not close the hole in his heart because his lung pressures were too high. Dr.'s told me there was "no hope".
Three months later, we were in the Dominican and my son underwent Autologous Stem Cell Treatment. Within DAYS his endurance doubled. 3 months later his pressures continued to decline and 6 months later they were low enough to close the hole in his heart! Now, 18 months later, his heart is no longer enlarged and his pressures are more than 1/2 of what they were. He just finished his season in baseball and is registered for fall ice hockey.
There is a similar treatment clinical trial (IN HUMANS)in Canada where much data and research is being compiled and presented and probably to your liking because 7 years later and millions of govt dollars later, they are still doing the trials...do you realize where my son would be 7 years into his disease? Even stem cells have its limitations!!
MY DAUGHTER INLAW HAD ADULT STEM CELL BYBDR. GRECO HE IS MY MIRACLE MAN AS HE SAVED MY LOUANN. SORRY I CAN;T TYPE MUCH BUT BELIEVE ME IS THE BEST. DOUBTERS BE GONE, THIS IS FOR REAL
Nahla, I am so happy for you and your son. Iwish him continued good health. WE are so blessed to have been able to receive our therapy. God bless you.
Today I have another friend having her stem cell therapy done. Wishing you much success Nancy. Love ya.
ptownhero, I will show you my medical records any day you want to see them. I have test done at the Mayo Clinic, my local doctors and Dr. Grekos. They all agree. So any day you want to doubt us just let us show you our results.
Wishing everyone that has been blessed enough to receive their stem cells much good health and long healthy lives. May we all continue to live life and stop watching it from the sidelines.
"Hans Keirstead of the University of California at Irvine calls commercial stem-cell clinics like Regenocyte “deplorable.” “It’s absolutely terrible. They’re taking advantage of people’s need,” he says."
How can such a bright person be such an idiot? When a grocer sells a can of peas, he too is "taking advantage of people's needs." No need, no market. DUH.
Would Prof. Keirstead push stem-cell therapy only on people who don't require it?
God forbid we should have the freedom to make our own decisions - including, inevitably, some bad ones - about our own bodies! And we all know how wise and caring the FDA is. Let us by all means demonize Grekos and other pioneers, and conveniently forget that progress comes about only through the efforts of those who don't accept the status quo.
I don't know whether stem-cell therapy is the answer to many vexing problems or a complete waste of time and money, though I suspect the former. That's not the point. Each of us is ultimately responsible for his own health. If I decide to try something unapproved or even highly questionable, well - it's my body. Pity these people have to travel thousands of miles from home to get the benefit of research carried out in their backyard.
Nahla, I was refering to research in animal stem cell lines in animal models, not human stem cell lines in animal models. The reason we have approval processes, the FDA and regulation is because this "my body ill do what I want" philosphy in regards to medicine and surgery has historically lead to massive casualties- think third world surgery and cyanide pills as treatment. If you travel to eastern europe you may notice a very high instance of people in their 50's with serious physical deformities. This is because a drug back then, Thalidomide, which was perscribed far and wide there for morning sickness in pregnant women was an incredible teratogen. Thankfully our FDA was more stringent, blocking the drug and preventing millions of babies from suffering horrible birth defects.
If Regenocyte is a method of last resort and your willing to try anything, fly to the third world for risky medical procedures and buck the recommendations of our best doctors and scientists, nobody can stop you. Forgive me if I dont exactly trust Dr. Greko's supporters on this site- for 60K a therapy he can afford to have people write a number of positive reviews especially on such a high profile article.
If you have any other doubts about this- watch http://www.youtube.com/watch?v=Rb2NBlmL1es. There is also a pretty awesome 60 minutes peice exposing another offshore stem cell scammer.
In the interest of full disclosure, it should be noted that one of Dr. Grekos's frequent critics, Dr. Irving Weissman, has a substantial financial interest in embryonic stem cell research. To balance the 60 min clip on youtube check out www.fumento.com/biotech/greatstemcell.html
I'm wondering why Dr. Greko isnt willing to let a third party oversee the procedure or validate results! If the procedure is as great as its worked up to be than the results will speak for themselves and these comments wont be the only thing holding up any support for the procedrue. Im not against him, hes doing a good thing, trying to help people is great. But how effective is this procedure? Testimonials aren't actual scientific evidence, and they never have been.
The point that is being overlooked here is that mixing growth factors/multiplying the cells is not safe unless it is a regulated dose that has been through proven trials. Just taking stem cells and transplanting them is not is what is in question, that is not what the FDA regulates and not what this is about. What the FDA is saying is that you cannot just mixup a bunch of compounds in the OR and transplant them into your patients. It could be stem cells, BMP's, steroids, it doesn't matter. If this guy had his way he would probably be cooking Viagra in his garage and selling it at the swap meet. I don't know why he's complaining either, without the FDA he wouldn't have been able to carve out is nice little medical tourism niche in DR. I don't think it's wrong for people to take a risk on experimental treatment, I just hope they are well informed and know exactly what they are getting into first.
As the stage for stem cell therapies advances with better science, more clinical data, and new trials, these type of treatments will advance, albeit it may take years. But it is important to understand, the today's common place prescription meds, and treatments have taken 7- 10 years to develop as well. So stem cell-based therapies are still in their early stages. While the critics, including Dr Robert Lanza of Advanced Cell Technology certainly have taken the right approach with their comments, many factors for patient safety have already improved in just the last two years. Once Big pharma gets some of he stem cell firms on its radar, investment will flow and quicker development should occur. Big pharma is slowly getting its feet wet with investment. The humanistic side of this as indicated in this article is touching as people are just trying to survive the ravage of a disease and extend their life.