Invited to a Stem Cell Seminar for Back Pain or Joint Pain? 10 Questions You Should Ask Before Signing up for the Procedure.
Unless you are living in a cave, most of you have seen ads as shown above inviting you to attend a Stem Cell Seminar for Back Pain or Joint Pain. If you are suffering from pain, this sounds like music to your ears. However, all stem cell clinics are not cut from the same cloth. It is very important to find the right clinic to avoid complications and to get the best possible results-especially when the money is coming straight from your pocket. The purpose of this blog is to inform you about how to find the right clinic to treat your back and joint pains while avoiding scams.
What could happen if you choose the wrong clinic:
STEM CELL COMPLICATIONS REPORTED IN THE MEDIA
As many media reports have shown, there are a lot of bad players in this field who scam vulnerable patients. CNN reported that a patient died when stem cells were used to treat a heart condition. Additionally, a report from Scientific American revealed that a California woman developed painful bone fragments in her eyelids after a stem cell facelift. Another patient developed a mucous-secreting growth of nasal tissue in her spine after undergoing stem cell treatment in an attempt to cure her paralysis. Furthermore, CBS news televised a story about 3 women in Florida who were blinded by stem cell procedures. Also, the Washington Post has reported a patient in Georgia who was also blinded by a stem cell procedure. Lastly, Dr.Oz televised a show about a doctor in Florida whose patients died from strokes after a stem cell procedure. E-Coli bacterial infections have been reported by CNN in 12 patients who received contaminated Umbilical Cord Stem Cells.
STEM CELL COMPLICATIONS PUBLISHED IN SCIENTIFIC LITERATURE
Stem cell complications have also been reported in medical literature. The prestigious New England Journal of Medicine [NEJM] published an article about 3 women in Florida who were blinded from stem cell injections. NEJM reported a case where a patient developed a spinal tumor and paralysis after a stem cell therapy. Additionally, the medical journal Spine reported a case of severe spinal infection after stem cells were injected to treat back pain.
2. They don’t provide the pain relief you seek
Even though stem cell treatment complications are rare, they are devastating and life altering. Sadly these could have been avoided as they are almost always a result of poor medical practice. Equally important is the fact that most patients, in spite of spending large amounts of money, are not seeing results. Recently, Dr.Oz had a show about how stem cell clinics are scamming patients by not providing the promised pain relief. It is also worth taking a look at his blog regarding an investigation of fraudulent stem cell clinics which explains how to identify them as well. A television channel in Denver had an investigative report about the aggressive advertisement tactics and poor patient outcomes by these stem cell clinics. TV and print media journalists are increasingly reporting about these clinics all over America.
What about lawsuits against shady stem cell clinics?
After receiving numerous complaints from patients who got poor pain relief [some actually had increased pain after the procedure], the state of North Dakota ordered a clinic to stop non-FDA stem cell procedures and ordered the clinic to pay back $20,000 to the patients. Additionally, there is a class action law suit in North Carolina against a stem cell clinic offering dubious treatments. Another lawsuit is brewing in California where 5 patients claim to have been victims of false advertising by a stem cell clinic. Similarly, 6 patients are suing another company in California for being misled into believing that treatments, still in the experimental stage, had already been proved effective. Law suits are being filed by the aforementioned patients who were blinded in Florida.
What is the Government doing to protect patients?
The Federation of State Medical Boards [FSMB] has paid attention to these complaints and is in the process of drafting guidelines to regulate stem cells clinics in order to protect patients from scams. California and the state of Washington passed a law requiring stem cell clinics to post warnings that their treatments are unapproved by the FDA. The FDA has also jumped on this bandwagon, and is seeking injunctions to stop two stem cell clinics from providing care to patients. These clinics were in clear violation of FDA stem cell regulations. The FDA is also facing pressure from Senators to take action against these illegitimate clinics.
Can the Government do enough to protect patients?
With an estimated more than 500 stem cell clinics currently operating and new ones mushrooming everyday, it is practically impossible for the Government to take action. The FDA stated in their latest stem cell guidelines that their priority is policing stem cells administered by intravenous injection, aerosol inhalation, intraocular injection, or injection/infusion into the central nervous system. They will also closely look into procedures used for the prevention or treatment of serious and/or life-threatening diseases and conditions. Unfortunately, stem cell procedures for back pain and joint pain are typically done with an intra-articular (in the joints) approach. Furthermore, these procedures are usually done to treat arthritis, which is not life-threatening. Therefore, these procedures will escape FDA scrutiny.Hence, the onus is on you to pick the right clinic in order to avoid complications and get the results you desire.
Now that you are on you own, what should you do?
When you are invited to a Stem Cell Seminar for Back pain or Joint pain, these following recommendations will help you to identify a illegitimate clinic.
As reported by various media, shady stem cell clinics generally tend to spend a lot of money on advertisements in the TV/newspaper or radio. Do not fall for that bait.
Do your research on the internet. There will be many clinics near you. Thoroughly check out their websites. I will detail below what you should be looking for in those websites.
1o questions you should be asking in the stem cell seminar for back pain or joint pain.
This is the most important part of the blog. Once you have decided to go the seminar, or if you are at the first consultation in a clinic, these are the questions you should be asking.
Is the clinic owned by a physician or a business entity? Mostly, but not always, when a clinic is owned by a business entity, their primary motive is profits. Patient care is secondary. Not surprisingly, most stem cell clinics are not physician owned. The owners usually are business entrepreneurs or chiropractors.
Is the procedure being done by a physician or non physician? Usually, these clinics employ nurse practitioners or physician assistants to do the procedures. They are supervised by a physician who may or may not be on site. While this is legal, it is not good medical practice. In fact, when a physician assistant performed the stem cell procedure in Florida it resulted in 3 patients going blind. Beware of these clinics!!!
If a physician is performing the procedure, is he/she a specialist in the area of injection? Many physicians are jumping on to the stem cell bandwagon because they are realize its profit potential. Primary care physicians or physicians who are not specialists in the particular area of pain should not be doing these procedures, unless they receive extensive training from legitimate sources.
Is the physician following FDA allowed protocols? Since this is a new field, safety of the patient is paramount. FDA allowed procedures can reduce complications. Also, it assures you that the clinic is legitimate.
Is the clinic using amniotic stem cells, umbilical cord stem cells or fat stem cells? The FDA has clearly spoken that all the above three types of cells are illegitimate and should not be used for regenerative purposes unless they are a part of FDA approved clinical trials. As stated before, the FDA has sought injunctions against 2 stem cell clinics offering adipose stem cell procedures. It has also sent warning letters to numerous companies which produce amniotic stem cells. Additionally, these are not your cells. Remember, once these cells are injected, they cannot be removed. If these clinics are not following the rule of the land, you should be skeptical.
Is the clinic using bone marrow stem cells? Bone Marrow stem cells seem to be allowed by the FDA. So far no stem cell clinic has ever gotten into trouble with the FDA for using bone marrow stem cells. Bone marrow stem cell extraction takes time, training and expertise. Hence most sham stem cell clinics shy away from them. Its much easier to inject “over the shelf” amniotic or umbilical cord stem cells which are available in a vial.
Is the clinic treating only back/join pain or many conditions like cancer, rheumatoid arthritis, neuropathy and other complex neurological conditions? Treating back pain or joint pain using stem cells is very complex. It takes a lot of expertise to perform these procedures safely and effectively. It is not possible for one physician to treat other complex conditions along with spine and joint pain with the same level of care and expertise. More over, there is not much clinical evidence regarding safety and efficacy when treating the conditions mentioned above.
Is the physician using fluoroscopic guidance or ultrasound guidance to perform these injections? Back and joint pain is usually multifactorial. Its not just one structure which causes pain but usually multiple structures within the joint that cause pain. For example, knee pain can stem from arthritis in the joint lining, along with degeneration of the ligaments and necrosis of the bone. Unless all these structures are injected, it is difficult to get pain relief. Precise injection of these structures requires the use of fluoroscopy or ultrasound. It also needs special training. If the clinic is not using this equipment or not injecting multiple structures, you should be skeptical.
Is there a lot of sales pressure to sign up for the procedure after the seminar or after the consultation? One of the telltale signs of a shady stem cell clinic is the pressure for a sale after the seminar. Some even have a “patient co-ordinator” whose job is to get you an approval for a loan, in case you cannot afford the procedure. The reason for them doing the seminar is not for educational purpose but to make sales. Avoid these clinics as they don’t have your best interest in mind.
Is the clinic following up with patient outcomes by using a patient registry? This will tell you if the clinic is genuinely interested in knowing if their procedures are providing the pain relief or not.
Stem cells work very well in a lot of patients suffering from back or spine pain. Finding a legitimateclinic is the key to success. Most people do research before they buy a car or TV. This is no different. When invited to a stem cell seminar for back pain or joint pain, do not sign up for a procedure immediately. Ask questions. Do your research. By not doing so, many people have unfortunately paid a price literally and figuratively as the media reports have shown. Do your research and the find the best clinic. I hope you got valuable information from this blog and it helps you in making the right decision. After all its your hard earned money and your most importantly your health!!!
Dr. Sairam Atluri is a pioneer of stem cell therapy in the Cincinnati area. He is one of the very few in the country performing intra-discal and subchondral injections to treat back pain and joint pain. He gives national talks and teaches other physicians about stem cell therapy. He is also a co-editor of one of the largest textbooks about regenerative medicine. Dr. Atluri is part of the team which wrote the ASIPP guidelines for stem cells to treat back pain. He is one of the few in the area to be certified in Regenerative Medicine by American Society of Interventional Pain Physicians [ASIPP].