Stem Cell Therapy – What Patients Should Know! The Truths and Myths.
I want to emphasize that this article is about stem cell treatments for back pain and joint pain. There is a lot of confusion regarding stem cell therapy among both patients and physicians. I hope this blog would bring some clarity. The questions that will be addressed are
Is there any clinical evidence that stem cell therapy for back pain and knee pain works?
Why are all the stem cell clinics NOT the same?
How can you differentiate a legitimate stem cell clinic from a fraudulent stem cell clinic?
1. Is Stem cell therapy for back pain and knee pain really the latest innovation?
Here are the reasons why…
For the first time, we are able to treat pain by healing the joints. Traditional treatments like Drugs, Steroid injections and Surgery which are used to treat pain are destructive to the body. Also, they are not very successful in treating pain. It’s no surprise that 20% of Americans suffer from Chronic Pain.
For the first time, we are able to use the patients’ own cells to treat pain by harnessing the power of mother nature. It is the most “natural way” to treat pain.
Compared to Drugs and Surgery, the side effects and complications are minimal. [If done properly and ethically]
Compared to Drugs and Surgery, the cost of stem cell therapy is significantly less. [If done properly and ethically]
Compared to Drugs and Surgery, the success rate is higher. [If done properly and ethically]
It should be emphasized that Stem cell therapy should be ” done properly and ethically”. I will explain this later.
2. Is there any clinical evidence that stem cell therapy for back pain and knee pain works?
Although the clinical data for Stem cell therapy for back pain and knee pain is preliminary, it is very positive. It has a lot of promise and this is the quote from the ex-FDA commissioner, Scott Gottlieb.
EVIDENCE FOR KNEE PAIN
Dr.Phillipe Hernigou has been performing bone marrow stem cell procedures for joint pain for the last 30 years. His work showed that
In his landmark study, he enrolled 30 patients with severe pain in both knees from serious joint destruction. Each patient received stem cell therapy in one knee and a total knee replacement in the other knee. He followed the patients for 12 years. He found that
He found 70% of patients were satisfied with stem cell therapy and only 30% were happy with a knee replacement.
Not surprisingly, there were more complications in the knee replacement group.
Even after 12 years, pain relief from stem cell therapy did not diminish.
20% of the knee replacements required a second knee replacement surgery
Knee regeneration was seen in patients who got the stem cell treatment.
Among all joints, stem cell therapy has been most studied in the knee. Here is a compilation of all the bone marrow knee stem cell studies.
Numerous studies have been published regarding the use of micro-fragmented adipose tissue [MFAT] stem cells. This maybe FDA allowed.
EVIDENCE FOR BACK PAIN Regarding back pain and stem cells, the best study is from Dr.Kenneth Pettine. He is an orthopedic spine surgeon from Colorado. He identified 26 patients who were suffering from back pain. Their only option was a back fusion surgery. Instead of performing fusion surgery, he injected patients’ own bone marrow stem cells into their discs. He followed these patients for one year. These are his findings.
70% of patients reported significant pain relief.
Most importantly 76% of patients avoided surgery.
40% of patients had disc regeneration
There were no complications
Dr.Pettine later followed these patients for 5 years. He reported that even after 5 years, patients continued to report pain relief. In another important study, 10 patients who were suffering from back pain were selected for back fusion surgery. To avoid surgery, these patients’ discs were injected with their own bone marrow stem cells. These bone marrow stem cells were tagged to they could track them in the body. 50% of patients [5 patients] got significant pain relief and avoided fusion. Out of the remaining 5 patients, 4 had surgery during the study period. The disc material which had injected stem cells was removed during surgery and analyzed. The authors of the study found that
Injected stem cells survived in the disc
Stem cells replicated in the disc
Some of the stem cells turned into cartilage cells
Stem cells produced collagen and extra-cellular matrix which indicates regeneration
Other smaller studies were done using non-FDA approved stem cells which also showed positive results. This table is a compilation of all stem cell studies [FDA allowed stem cells and Non-FDA approved stem cells] done to treat back pain. In conclusion, the clinical evidence for stem cell therapy for back pain and knee pain shows that
The evidence for stem cell therapy for back pain and knee pain is preliminary
The evidence is very positive
If done appropriately, there are no complications
3. ARE ALL THE STEM CELL CLINICS THE SAME? NO. As I emphasized earlier, patients will experience good results only if this procedure is done properly and ethically. I cannot highlight this point enough. There is a reason for this. Unfortunately, there has been an explosion of “scam” stem cell clinics in America who are preying upon desperate and naive patients. These clinics are not only providing substandard and dangerous care but charging ridiculously high fees. In one shocking example, a clinic in California was charging a firefighter $30000 to inject multiple joints. All he had was a pain in one knee joint. You have to be sick to cheat a firefighter who risks his life to save others. Sadly most patients are not aware of the existence of the “scam” stem cell clinics. Patients think all stem clinics are the same. Nothing can be further from the truth. These “fake” stem cell clinics hurt patients by
Providing poor results
Charging enormously high fees
Causing severe complications like blindness, serious infections, tumors, and death.
Not following the FDA stem cell therapy regulations
By tarnishing the reputation of stem cell therapy, there is a danger of stem cell therapies being banned. Stem cells have been banned in Canada.
Our government is trying hard to prevent the harm done by these unscrupulous clinics. Senator Grassley wrote to the FDA asking them to take serious action against these dubious clinics. Senator Frank Pallone also addressed his concerns about the “shady” stem cell therapies to the FDA. Some of the actions taken by the FDA to curb this illegal activity are
Stopping 2 of these clinics from performing illegal procedures.
Sending a warning letter to 20 clinics who were accused of providing illegal stem cell therapy.
Sending warning letters to manufacturers who were creating illegal stem cell products
Recalling illegally manufactured stem cell products which caused complications
Creating a patient advisory warning about these clinics on their website.
Creating a webpage where patients can inform the FDA if they have been harmed by stem cell therapy
The FTC [Federal Trade Commision], State Attorney Generals [New York and North Dakota], State Medical Boards have also taken action on some of these fraudulent clinics. Patients have also sued these clinics. Regrettably, this is only the tip of the iceberg. There are so many scam clinics beneath the surface that it is not possible for the government to identify them and take action. Unfortunately, most doctors do not know much about stem cell therapy. Your doctors are not capable of guiding you. WHICH MEANS YOU ARE ON YOUR OWN. If you are considering getting stem cell therapy for back pain or knee pain, please do your research before signing up because
It is your hard-earned money
Most importantly it is your health
4. How can you differentiate a legitimate stem cell clinic from a fraudulent stem cell clinic? The first red flag is when you get invited to a seminar or you get a mailer at home or you see an ad on Facebook. These “scam” clinics spend a lot of money on advertisements, sometimes up to hundreds of thousand dollars a year. They have to recuperate their costs. They do this by
charging huge fees
most importantly, offering the procedure even if you are not a candidate for the procedure
Don’t be their bait. These are the questions you should be asking the clinic.
First question. What stem cells are you using?
FDA compliance is very important for legitimate stem cell clinics. Currently, among all stem cells, bone marrow stem cells seem to be the most compliant. They have the longest history of safety. Most clinical studies in back pain and knee pain show that they are very effective. Most importantly since they are your cells, there is no risk of infection transmission or allergic reactions. Contrary to the common belief bone marrow aspiration is not painful because
patients are sedated
local anesthesia is used
small aspirations are done at a time.
The other myth is that as we age the number of stem cells decreases dramatically, so elderly patients do not get pain relief. However, bone marrow aspiration is done from the back of the hip in a bone called iliac crest. As we age, the number of stem cells from this bone does not decrease as dramatically as seen in other bones. This is why good results are seen even in older patients. Most legitimate stem cell clinics use bone marrow stem cells. Some use fat stem cells that may be allowed by the FDA. The source of these stem cells is called “Micro-fragmented Adipose Tissue [MFAT] “. Destructive enzymes like collagenase are not used to extract stem cells from fat tissue. FDA does not approve of using the collagenase enzyme to create a product known as SVF [Stromal vascular fraction]. However, the scam clinics use either Amniotic or Umbilical cord stem cells. These are clearly not FDA approved. They use these cells are that are delivered to the clinic in a vial. They use these cells as they do not have the expertise to perform bone marrow aspiration. The problems with Amniotic and Umbilical stem cells are
They are not FDA approved. I have heard through patients that they were told by these clinics that Amniotic and Umbilical cord stem cells are FDA approved. Don’t believe them. See this video created by the FDA which explains this.
Numerous independent studies have shown that the Amniotic and Umbilical cord stem cell vials sold to the doctors HAVE ZERO STEM CELLS. They have growth factors that help with the pain. But it is not as powerful as stem cell therapy and should not be sold as such.
Many patients had serious infections from getting umbilical cord stem cell therapy. Some of them were hospitalized for 2 months. This was from poor donor screening and dirty tissue processing. When the FDA visited the lab, they found significant deficiencies in sterility.
Repeated injections of these products can cause severe allergic reactions.
There are no clinical trials showing the safety and efficacy of these products to treat back pain or knee pain
2. Second Question. Who would be performing the procedure? Good results without complications are possible only if the procedure is performed by qualified and well-trained physicians. Legitimate clinics usually have physicians with appropriate credentials performing the procedure. To find out if the physician is qualified, ask the following questions.
Is the physician board certified in the specialty which treats back pain and/or knee pain? These specialties are usually orthopedic surgery, interventional pain management, physical medicine and rehab, sports medicine, interventional radiology.
Is the physician does not belong to the above specialties, is he/she received extensive training in the stem cell procedure?
Is the physician certified in stem cell therapy? This may be rare to find as currently there is only 1 legitimate certifying organization.
“Scam” stem cell clinics rarely have physicians with the above qualifications. Some of these egregious clinics even employ non-physicians like nurse practitioners or physician assistants to do these procedures. In some states, even Naturopaths are also doing these procedures. They do not have the expertise to perform these procedures. More importantly, they are not equipped to identify and treat complications. 3. Third Question. What structures would you be injecting? The spine and joints have multiple structures that can cause pain. Back pain can be caused by the discs, facet joints, sacroiliac joints, nerves, ligaments, and muscles. Knee pain can be caused by the bones, cartilage, multiple ligaments and meniscus. In most cases, the pain is coming from multiple structures and not one structure. Unless all the affected structures are injected, you will not get the best results. To get the best results for back pain, most likely the discs have to be injected. Similarly, in cases of severe arthritis of the knee, unless the knee bones are treated, you will not see optimal results. Injecting the discs and bones does require specialized training and proficiency. Ask the provider,
Have you identified all the structures that can cause back pain or knee pain?
Will you be injecting all the structures that are causing the pain?
Most importantly, will you be using fluoroscopy or ultrasound machine to precisely deliver the stem cells to the painful structure?
4. Fourth Question. Does the clinic treat any other conditions apart from pain? Legitimate clinics using stem cell therapy for back pain and knee pain do not treat other conditions. They treat only pain conditions. Scam clinics usually treat a myriad of conditions from neurological diseases, lung problems, autism, heart problems, hair loss, erectile dysfunction, etc. Treating back pain or knee 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. Moreover, there is not much clinical evidence regarding safety and efficacy when treating the conditions mentioned above. 5. Fifth Question. Who owns the clinic? Make sure the clinic is owned either by a physician or a hospital. Generally, these clinics tend to put patients’ interests first. Avoid clinics that prioritize profits. These are usually owned by
For more in-depth identification of the scam clinics, click here In conclusion, many are suffering from chronic back pain and knee pain. Unfortunately, traditional treatments do not provide relief to most. Stem cell therapy for back pain and knee pain has the potential to help these patients. Beware of the “scam” stem cell clinics that are preying on vulnerable patients. This can lead to poor results and sometimes complications. Do your research and find a legitimate stem cell clinic close to you. Hopefully, this broad overview had equipped you with tools to get the best possible stem cell therapy. It’s your money and 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].