FDA Compliance treating knee arthritis

NON-SURGICAL KNEE ARTHRITIS TREATMENTS CAN GET YOU ACTIVE AGAIN WITHOUT SURGERY!

 

The doctors at Southcoast believe regenerative therapy is the future of medicine.  Patients who previously would have had surgery, are now finding relief without going under the knife, with less recovery time, less major risks, and no hospitalization.  The promise of Regenerative Medicine and stem cell therapy is incredible. 

cell therapy can get you active again!

 

In 2017 the FDA commented that they decided to regulate cell therapy more aggressively. Their concerns were that there were “bad actors” in this field who were offering products that could be dangerous and may have little potential for benefit.  Many healthcare groups offering regenerative treatments were making incredible promises and even offering treatments to cure COPD and vision issues, with more than one patient sustaining further injury.

How does a patient know whom to believe?

On June 6, 2021, the FDA published “Important Patient and Consumer Information About Regenerative Medicine Therapies”. This statement was intended to caution the public about “Stem Cell” clinics that had been making false and fraudulent statements publicly and performing unapproved and potentially dangerous or life-threatening procedures without sound scientific proof for safety or efficacy.

Southcoast Medical, is an affiliate of the Bluetail Medical Group, and our centers in Missouri, Naples Florida, Wisconsin, Minnesota, and Arkansas conduct clinical research and currently have an investigational new drug (IND) application filed with the FDA for the use of bone marrow concentrate in the treatment of knee osteoarthritis (IND #27390.) We are committed to applying for and obtaining multiple future IND’s for other orthopedic conditions. We continue to compile outcome data on treatments for numerous musculoskeletal conditions. We have successfully published our outcome data related to the treatment of knee osteoarthritis as well as elbow ligament injuries in throwing athletes.

We started Southcoast Medical to give patients non-surgical options that really work. Many of these are not covered by insurance, but we hope one day that will change. Evidence mounts monthly that these procedures can be effective. It is our goal to offer patients procedures that have a good chance of success and that we, were we the patient, would choose to do ourselves.

When you are trying to choose your best option for regenerative treatments, consider this:

  • Choose a Medical Group with board certified physicians, not one run by ancillary providers
  • Expect to be seen and evaluated by a doctor
  • Expect your provider to understand your issues, be familiar with interpreting your studies, and able to offer you options
  • Consider a group that is currently following all current FDA directives and is committed to furthering the ethical advancement of autologous cell treatments

We believe regenerative medicine works, and our goal is to give you your best option for success. Often this is with regenerative treatments, but not always. If that is the case, we will explain why and direct you to those who can help.

At Southcoast, we are striving to give you the best options available, those we would choose were we in your position.

Come see us!

 

 

Can Cell Therapy Successfully Treat Chronic Back Pain?

Can Cell Therapy Successfully Treat Chronic Back Pain?

 

Chronic back pain can be one of the most disabling issues a person can develop. Current treatment options often fail to provide relief, leaving many patients relying on opiods for for some semblance of normal function. There is little data that opiods continue to give long term pain relief.

Back pain is multi-factorial, and often discerning a single most profound cause is impossible, as is developing a single treatment modality. Surgical outcomes when measured by patient satisfaction and degree of pain relief, are often poor for chronic back pain. Non surgical options, too, can fail to give relief.  Standard treatment regimens rely on a series of common modalities including:

  • over the counter medications
  • avoidance of activities
  • prescription nsaids
  • back bracing
  • Physical Therapy
  • Injections in muscle, epidural space, near nerve roots and in joints

Unfortunately, many patients fail these approaches to back pain and this has left us as physicians, searching for better treatment options.

Can PRP or BMC treat chronic back pain?

Over the past 20 years physicians have begun to treat back problems with newer options like cellular therapy. Cell therapy uses your own cells to try to find pain relief. This is typically not covered by insurance, nor are the treatments approved by the FDA. However, there is substantial science behind this work and many physicians around the world believe it to not only be a viable treatment, but better than our current conventional treatments.

In the first week of October, The Orthobiologic Institute held its annual meeting and there were many presentations on the use of cell therapy, including one by Dr. Sairam Atluri on the use of cell therapy to treat severe spinal degeneration.  Dr. Atluri gave the results of a study in which 80 patients were randomly separated to either a conventional treatment group, or to a cell therapy group. The cell therapy group was treated with lumbar injections which directed the patient’s own cells to treatment of joints, discs, muscle, and other areas. This group was then followed and their progress compared to a conventionally treated group.  There were some interesting findings in the group treated with BMC:

  • Back pain was markedly improved in the BMC group over 3,6 and 12 months
  • The disability index (ODI) improved in the BMC group
  • Function improved in the BMC group
  • There were no complications
  • Opiod use markedly decreased in the BMC treatment group

 

These findings strongly suggest that Bone Marrow concentrate may be successfully used to

treat chronic low back pain .  It is important to also note that the level of pain and disability remained constant in the group treated with

conventional methods, and the opiod use in that group actually increased.

 

Chronic back pain can be disabling. I have spent the last two decades of my life treating patients with chronic back pain and am all too familiar with the poor treatment outcomes, both surgical and non-surgical. I believe the data presented on the use of BMC this week is a big step in helping us to understand these newer treatment options, which may give patients more hope for a normal life.

The physicians at Southcoast Medical hope to continue to explore these options for patients. It is our goal to give patients every possible legitimate option to find long term pain relief. Studies like this, with no complications, and excellent outcomes over one year, suggest that cell therapy may help relieve chronic back pain.

If you have chronic back pain and would like to discuss this or other options, please get in touch.

SOUTHCOAST MEDICAL

843 990 8390 or GETACTIVEAGAIN.COM

Phillipe Hernigou and Bluetail data showing bone marrow success in treating knee arthritis

Bone Marrow Can Improve Knee Pain, Function, and Stiffness in the Treatment of Knee Arthritis

NEW INFORMATION FROM TOBI 2021

 

You may find yourself facing total knee replacement and you are looking for other treatment options.  New presentations at this year’s major Orthobiologic confernce, TOBI 201, have examined outcomes of treatment using Bone Marrow and given encouraging results!

Dr. Kristen Oliver is a good friend, and long time member of Bluetail Medical. She has treated knee arthritis with bone marrow since at least 2006 and along with Dr. Phillipe Hernigou, at this year’s premier Orthobiologic conference gave us  promising updates on new ways to treat knee arthritis pain.

 

First some background. Knee Arthritis is painful, limits activity, limits mobility, affects daily living, and affects 75% of people age 75 and over, and many younger patients as well. Knee Arthritis is a major cause of disability in the United States.

 

 

For the last few decades, the treatment of knee arthritis has followed a specific protocol, ending in Total Knee Replacement, an irreversible surgery that leaves many in pain and causes many more long periods to recover. The AARP has published information suggesting that one in three patients is left in Chronic Pain after Knee Replacement.

Doctors who deal with patients after total knee replacement are aware of these poor outcomes. Though some patients do quite well, many do not.  Any patient with significant knee pain and arthritis on x-ray knows the standard treatment regimen:

  • rest
  • therapy
  • nsaids
  • bracing
  • injections, like steroid and hyaluronic acid injections

AND….if you fail the above:

  • TOTAL KNEE SURGEY

This lack of effective treatment options, combined with less than ideal outcomes in knee replacement, has led to the study of newer, less conventional methods of treatment. This includes options not approved by the FDA, nor covered by insurance, but options that have legitimate scientific basis for use and which are being used and studied around the world. Organizations like TOBI (The Orthobiologic Institute) have taken it upon themselves to make physicians aware of progress in this realm.  This year’s TOBI had encouraging information presented about the use of  BONE MARROW, (the patient’s own cells) to treat knee arthritis. Two of the most well known and exciting presenters were Dr. Kristin Oliver, and Dr. Phillipe Hernigou, with both presenting data that BMC may help relieve arthritis pain and function.

Dr. Hernigou, a French orthopedic surgeon who does over 200 total knee replacements yearly, has spent his last two decades studying other treatment options for knee arthritis, including the use of bone marrow concentrate (BMC). Previously, he had published many papers including a 2018 study on the use of bone marrow to treat knee arthritis.

In his discussion this year, Dr. Hernigou presented new information which was accepted for publication in the International Journal of Orthopedics in April 2020. This was a study that looked at 140 adults, all with serious knee arthritis in both knees and all aged 65-90. These patients agreed to have one knee replaced, and the other treated with BMC. The knees were randomized, then the patients treated and followed for 15 years.

Of 140 patients, 21 required revisions of the knee they had replaced. There were loosenings, two fractures, five patella fractures, and two patients who required anesthesia for mobilizations. Twenty five of the 140 patients chose to have Total knee surgery on the cell therapy knee knee (this was a similar percentage of more surgery to those who required repeat surgery on the operative knee). Not only did the BMC knees overall NOT convert to surgery, they also had slightly less pain and more improvement than the Knee which was replaced. Better pain relief in a  Non-Surgery knee in patients followed for 15 years. This is remarkable information and information that strongly suggests the use of BMC to treat knee arthritis is a very reasonable option.

Dr. Oliver, presented data on the use of BMC here in the U.S. to treat knee arthritis. She had good outcomes with improved mobility, function and less pain, in a treatment with few complications.

Using WOMAC scoring to quantify, she showed that patients could find pain relief from knee arthritis using BMC.  She also showed that there were few complications.

 

 

 

 

 

 

 

If you are facing knee replacement surgery you may want to consider other treatment options.

At Southcoast, our goal is to help you find the best treatment option for you, and provide it in

the simplest, safest, most professional manner possible. We believe options like PRP and BMC

are worth consideration.

If you need more information, contact us or look up the cited studies.

843 990 8390

or getactiveagain.com

 

Cell Therapy Efficacy in knee arthritis

Can we reduce pain from Knee Arthritis, and improve mobility, using PRP or BMC?

Knee Arthritis can be very painful and can cause disability, limiting a patient’s lifestyle significantly.  According to recent data 40% of people over age 40 have knee arthritis. This causes a substantial strain on our medical system. Traditionally, treatment options are quite limited ending in Total Knee Replacement. These options include:

  • Therapy
  • Bracing
  • NSAIDs
  • injectable steroids and hyaluronic acid
  • Finally…Total Knee Replacement Surgery

Physicians like me, who have treated patients with joint arthritis for many years, understand the negative consequences of this algorithm. Many patients who have Total Knee Replacement are unhappy. According to materials published by the AARP, as many as1 in 3 patients who undergo total knee replacement are left with chronic pain. Patients know this and are left looking for effective, less invasive options.

One of these options is one of the newer formulations of Hyaluronic acid, like Hymovis, or Durolane. These are typically covered by Medicare, are simple and easy to inject with little or no pain, and can provide fast relief. In our practice, we have been astounded by the number of patients who are unhappy with total knee replacement, had surgery before even trying these simple solutions.  We absolutely recommend trying this as a early treatment, if more simple options fail to relieve knee pain.

 

There are some patients who fail to gain improvement from hyaluronic acid or any other of the conservative approaches. Are they destined to go on to Total Knee Replacement?

Maybe not!

Most Orthopedic practices do encourage patients to move forward with Total knee replacement if they continue to have pain. But there are other options for relief, including PRP and the use of Bone Marrow Concentrate (BMC). Though neither of these options is FDA approved, and neither is typically covered by insurance (though sometimes PRP may be), both have a solid scientific basis for use.

This years Orthobiologic Conference (TOBI 2021) included physician presenters from around the world, one of which was Dr. Nicholas Fiz. He reviewed prior data for using PRP to treat knee arthritis, and then presented his own study showing good results in relieving pain and increasing mobility, using PRP. Patients with mild to moderate arthritis had good relief with 3 simple, in office injections of PRP. Patients with more severe arthritis still did well, but required the injection of PRP into the bone below the damaged cartilage. This included the most severe grade of arthritis with 68% of these patients remaining improved at 15 months post injection.

___________________________

With regard to the use of BMC, in 2015 my colleagues published a paper on the use of BMC for the treatment of knee arthritis.  You can access the full content here:

http://www.journalofprolotherapy.com/wp-content/uploads/volume_07_02_bone_marrow_knee_osteoarthritis.pdf

This paper, published in the journal of prolotherapy, revealed that:

“The short-term follow up after injection of autologous
BMC and adipose in patients with knee OA showed
excellent results including decreased pain, increased
function, improved activities of daily living and improved
quality of life.”

Though neither PRP nor bone marrow aspirate are approved by the FDA for use to treat arthritis, there are ongoing studies, including a new investigational drug study begun by our group, Bluetail Medical. These studies will take time, and many other studies will be done, but physicians around the world are using these techniques to try to give patients more options and avoid a surgery with less than ideal outcomes like knee replacement.

If you have knee arthritis and limited activity, come see us. Let us guide you through all the Medicare-covered options first. If these don’t work, we would be happy to have a discussion about PRP or BMC.

Contact us anytime:843 990 8390 or Getactiveagain.com

 

 

New Help for Bone Damage in Knee Arthritis!

Have you been told that surgery is the only option to treat your knee arthritis? Now there may be another answer!

We all know that the loss of cartilage is the primary issue in arthritis. This cartilage loss leads to pain and loss of function, and quite often medications and injections will not relieve the pain and disability. The next option presented may be surgery.

As recently as only many months ago, once a patient had developed bony changes beneath their knee cartilage loss, there was no option but to proceed with surgery.  That surgery was often a total knee replacement, with long recovery times and often poor outcomes. Now Arthrex may be giving us a better alternative with the intra osseous bioplasty.

Surgeons have known for some time that arthritis could lead to swelling in the bones adjacent to the joint. This is known as subchondral edema, and is associated with a great deal of pain. Researchers believe that cartilage loss leads to damage in the underlying bone, which then leads to an influx of blood with limited venous drainage. This can increase pressure in the bone, cause further bone damage and lead to pain. Remember occasions when you may have slammed your finger in a door. The tip would swell, and the finger would hurt like crazy, even when it was barely touched. This is the type pain subchondral edema can create. For years it was thought that once this occurred,  the only option for pain relief was to do surgery. Now we think there may be another option.

Intra Osseous Bio-plasty and cellular therapy

Earlier this year, Kasik published a study on the treatment of such knee bone lesions.  His conclusion was:

“Biologic treatment of Bone Marrow Edema of the knee using BMAC (bone marrow) and iDBM (bone graft)  is an effective adjunct to arthroscopy that provides short-term pain relief for BMLs associated with degenerative conditions of the knee.”

As you will note in the title, this article presupposes that these procedures will be adjuncts to knee arthroscopy.  The journal article references “short term relief” only because the study is new, and patients have yet to be followed long term. The hope is that the next paper will reference “long term relief”. But the bigger question is about  knee arthroscopy.  Is a surgical procedure really required for this new approach?

The article above, clearly suggests patients can get improved function and less pain through the use of a demineralized bone product, mixed with cellular therapy (your own stem cells that are taken from your hip). All patients in the study had arthroscopy, thus it is difficult to determine if the actual arthroscopic procedure played any role other than as a delivery agent of the major products. In light of studies showing no improvement in patients with degenerative arthritis treated with arthroscopy alone, the question becomes “can we provide these products without surgery and anesthesia?”   We believe these products can be safely and comfortably provided without surgery.

Knee arthritis can be disabling.  It can cause severe pain and limit activities and many people go on to have total knee replacement, with high numbers of patients having chronic pain even after surgery.  Research has shown that there is reason to believe cellular therapy can work for patients with knee arthritis.  In our clinic, we have found good success treating knee arthritis and we already address these subchondral problems by placing cells in this injured region. Nonetheless when failures patients do fail to get the degree of relief we had hoped for, one is often left to wonder if the subchondral bone changes are the reason. Now Arthrex may have helped us find a better solution to treat this problem.

It is important to understand that the actual procedure itself, is essentially the same as what we do now. The only difference is the addition of a demineralized bone product that may act as a scaffold, and give the new cells guidance as they work to become osteoblasts (bone precursors) and go on to create new, healthy bone.

Don’t wait for treatment

If you have knee arthritis don’t wait too long to seek treatment. Regenerative therapy is a very reasonable option, but using our own cells to heal is a balance between repair and regeneration. Once tissues are damaged beyond a certain point, there is only so much that can be done, and we are left with a “repair” process that may not be as successful as the regeneration we had hoped to obtain.  With this new option we hope to improve patient outcomes even further.

At Southcoast we are here to help.  We promise to have board certified physicians evaluate your issues, and help you find your best option to return to an active, healthy lifestyle. We won’t mislead you. We won’t sell you a product that has no chance of success.  Come see us soon and let us tell you if you might be a candidate.

 

 

 

Why did my Doctor tell me NOT to have CellularTreatments?

You have arthritis and have been told that you need  a knee replacement. Unfortunately, your friend had knee replacement and is miserable. He continues to have pain and has been unable to get back to sports and even to simply return to normal activities. In addition, you have done your research and you see that medical papers quote as much as a 1/3 to 1/4 chance that patients who have knee arthroplasty will have pain and limited function after knee replacement. You don’t want to go through that!

Despite fearing knee replacement, you need to do something. Your knee hurts and therapy, injections, and the high doses of motrin you take daily (which your doctor told you would ruin your kidneys and might cause a G.I. bleed) has not worked.

After looking through your options you come to the conclusion that cellular therapy might be your answer. You see how this could help with the pain and you’ve been told it may even help heal your tissues. Prior to having the procedure you decide to run it by your physician and are surprised to hear that he tells you NOT to go through with the procedure. “Don’t do it” he says. “There are no studies to prove this can work.”  “We need more research and many of these clinics are simply out for the money” your doctor stresses.

Why would he tell you exactly the opposite of what the regenerative medicine specialist told you?

You have read how many major athletes have tried stem cell treatments and attest to the success. Why is your physician opposed to this treatment?

Who should you listen to?

The Truth about Cellular Therapy

 

Here is the truth about using Cellular treatments for Orthopedic conditions.

Regenerative Medicine is the future of medicine.

Regenerative Medicine will change how we treat diseases and will affect virtually every medical specialty. It uses undifferentiated cells (cells that have the ability to grow into almost any cell type) to treat tissues that have been injured or lost to injury or disease. It allows our bodies to heal through normal mechanisms and we are only within the last two decades really beginning to understand the incredible potential of this breakthrough science. I believe the day will come when we no longer do organ transplants, but instead grow healthy new organs using this therapy.  Currently there are many trials and research ongoing including:

  • Stanford University conducting  a trial on the safety and efficacy of stem cell use in spinal cord injury
  • UCSD is conducting a trial on the use of stem cells to treat diabetes
  • University of Minnesota is currently studying the use of stem cells to replace damaged heart muscle
  • Stanford Univesity is studying the use of stem cells in eye disorders

and there are many more of these studies around the globe. Stem Cell research in other countries often includes research using embryonic cells. The advantage is that these cells are pluripotent, and can develop into any of the 200 different cell types in the human body, unlike the cells in our bone marrow or fat, which can only differentiate into certain cell types.

With regard to the efficacy of stem cells, here is a quote from a former FDA commissioner:

We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction”        FDA commissioner Scott Gottlieb  2017

You can read the press release in its entirety here.

Regenerative Medicine will, in the coming decades, affect virtually every major medical specialty and almost every major medical institution has, or is developing, a regenerative medicine department. This includes:

The above list is abbreviated with many, many more institutions in the United States and around the world developing regenerative medicine departments.  The research in regenerative medicine over the next two decades will change outcomes for a variety of diseases.

If Regenerative Medicine has such incredible potential, then why would my doctor tell me NOT to do it?

The story I have just described about the incredible potential of stem cells and other regenerative medicine therapies is balanced by another story. That story is the story of some providers (often not medical doctors) who see Regenerative Medicine as the Wild, Wild West, a poorly regulated and policed realm in which they can make large sums of money if their sales pitch is right. They see an option to capitalize on patient fears by promoting treatments for diseases such as:

  • Alzheimer’s
  • cancer
  • COPD
  • heart disease
  • spinal injury
  • ALS

The time will come when we can use Regenerative treatments for these diseases, but much more research is needed before we get to that point and you should stay away from any provider who tells you otherwise! The FDA this year shut down U S Stem Cell, which had been implicated in causing blindness in three patients through stem cell treatments to “cure” macular degeneration. Again, I don’t question that one day we will use regenerative medicine to cure macular degeneration. I simply don’t believe it is reasonable to suggest that time is now, nor to recruit and sell patients on such treatments.

Providers who currently promote treatment for cancer and systemic diseases using stem cells, prey on individuals with little or no knowledge in this realm, patients who are looking for any treatment. These providers sell these treatments, and contrary to FDA guidance, inject small samples of cells intravenously to treat almost any disease. The fluids they provide often don’t even contain any living cells (download and listen to the podcast BAD BATCH, episode 5). In addition to patients often not gaining from these treatments, there is documentation of many patients being harmed by such injections.

Your doctor may or may not be aware of the story recounted in the podcast Bad Batch and of the injury to patients in this instance. But more than likely he or she is aware that one of the risks of stem cell treatments is the risk that a patient may choose treatment from a provider who is poorly qualified and whose interest in patient well being is less than profound.  The truth is that in South Carolina most of the stem cell providers are not physicians, but instead are non-medical providers such as chiropractors who have hired a physician (with no experience) to simply inject cells. Why hire a physician? Because by law the Chiropractor is not allowed to give injections.  How do these offices know if the patient is really a good candidate for this therapy or not? …..Well, unfortunately in many instances ALL who are willing to pay are candidates!  Your doctor likely knows this too.

So if Regenerative Medicine has Potential in many areas, but more research is needed

Has cellular therapy been proven effective for anything?

At Southcoast Regenerative Medicine we believe that research already has given us reason to believe that cellular treatments can be effective in spine and joint disease.  It is possible that your doctor simply is not aware of the advances that have been made, nor the clinical studies that have shown some success.

Many patients come to us for knee pain secondary to arthritis. We share Mayo Clinic’s belief that regenerative treatments can help with arthritis pain in the knee, and in other joints, and we use the same techniques using autologous treatments. We also believe that when compared to the poor outcomes associated with the current standard of care:

  • arthroscopic surgeries (no better than sham surgery in degenerative knees)
  • nsaids (G.I. bleeds, kidney issues, possible heart disease)
  • hyaluronic acid and steroids (into the joint steroids may destroy cartilage faster)
  • cartilage microfracture (which grows fibrocartilage rather than hyaline cartilage…..different properties)
  • Joint replacement (high risk of chronic pain)

that these treatments are often a very reasonable option. Many physicians are simply unaware of the advances in this realm and are likewise unfamiliar with the poor outcomes of current, widely accepted approaches to joint arthritis. Most patients are aware that high dose Motrin and other non-steroidal medications rarely solve joint pain and can be dangerous. Physical Therapy fails to give pain relief and joint injections only rarely work. Studies have shown that arthroscopic surgeries in patients with degenerative joint issues, are typically as ineffective as sham surgery. The British Medical Journal reported that one out of three patients has chronic pain after total knee arthroplasty and one such case and the seriousness of this issue was described in an article last year in the Washington Post.  Unfortunately, once a patient has had knee replacement, there is little that can be done to relieve such pain. We at Southcoast Regenerative Medicine have treated these patients for years, and have searched for newer, better, treatment options. The same is true for our approach to patients who fail spinal fusion. NBC news recently did a story on the poor outcomes of spine surgery, citing a study in the journal Spine that showed such surgery may be associated with more pain. The study reviewed 1450 patients who had spine surgery, revealing only 26% returned to work after two years. Again, we have treated these failed spine patients for years, are familiar with the miserable outcomes associated with some of these surgeries and the complete failure of medicine to offer a satisfactory alternative. We think Cellular treatments may be the start to better alternatives.

Research evidence suggesting cellular therapies may work

Many major institutions around the United States, and around the world, offer autologous stem cell for the treatment of arthritis pain and are getting good results. There is significant laboratory research to explain why and how autologous stem cell treatments may work.

The primary issue in arthritis is loss of cartilage. Physicians have believed for many years that once cartilage was gone, it was gone forever, however we now know that is not true.

Dr. Freddie Fu is an orthopedic surgeon at the University of Pittsburgh.  He runs an Orthopedic department that is deep into research involving the use of cells in musculoskeletal disease. They have shown that stem cells in the lab can grow new cartilage. Dr. Arnold Caplan Phd, at Case Western, who is a long time stem cell researcher known around the world, has shown similar results. These eminent professionals have shown that under laboratory conditions mesenchymal stem cells have the power to

  • self replicate
  • stop inflammation
  • grow cartilage, bone, muscles, ligaments and other tissues

Recognizing that cells can grow cartilage in the lab, then leads us to ask if we can use cells in clinical settings to grow cartilage in patients with arthritis. While the answer to this question is still being debated, orthopedic surgeon Dr. Jason Dragoo at Stanford, has presented evidence of such growth at TOBI conference 2018.

Dr. Fu and his research team in Pittsburgh have also examined the quality of cartilage grown under lab conditions and have shown that the cartilage growth is not scar tissue, but healthy, mature, normal cartilage, with tensile properties consistent with healthy tissue. The implications of the above findings in the treatment of arthritis are overwhelming.

Despite the above, those in medicine realize that sometimes lab studies don’t convey to clinical (patient) use as well as one might think. However, we at Southcoast think that current research has shown promise for clinical use.

In April 2019 an article published in Stem Cell Translational Medicine recounts significant improvement in patient’s pain, function and quality of life, using autologous stem cells. The full article, “Bone Marrow Mesenchymal Stromal Cells in Patients with Osteoarthritis Results in Overall Improvement in Pain and Symptoms and Reduces Synovial Inflammation,” can be accessed here. The main conclusion published was that “autologous bone marrow stem cells (BM‐MSCs) are safe at all doses tested and  likely improve various dimensions of knee‐specific joint function and quality of life”. The authors also note “early clinical data have also demonstrated improvements in cartilage volume and quality.” Perhaps this data will be the beginning of clear evidence of cartilage growth.

Another stunning article exhibiting the remarkable clinical success of cell treatments for arthritis was published by Orthopedic surgeon  Dr. Phillipe Hernigou, from Val de Mame University in Paris In January of 2018.  Dr. Hernigou’s work, STEM CELL vs. TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS details the use of stem cells in patients with osteonecrosis of the knee. Osteonecrosis is essentially a more rapid progression of arthritis which destroys the knee joint faster and typically in younger patients. Dr. Hernigou studied 30 patients who had such arthritis in both knees.  The study was a prospective, randomized, controlled clinical trial in which each patient agreed to have stem cell treatment on one knee and total knee surgery on the other knee. The patients were followed for between 8 and 16 years, (average of 12 years). The results did not reveal stem cell treatments to be as good as total knee arthroplasty, but instead better with 21 of 30 patients (70%) preferring the stem cell knee as the better treatment option.

One of the interesting things about this research is that quite often it is orthopedic surgeons who are publishing this data. Despite this, many in the orthopedic community either remain unaware of these results, are unaware of the terribly poor outcomes with traditional orthopedic approaches, or simply don’t believe it is clinically useful for some other reason. Sometimes these surgeons will dismiss the use of cell therapy now, because “we need more research” or because “no randomized, controlled clinical trials have been done” or because we cannot be sure patient improvement is not from “the placebo effect.”

While there is much more research to do, we disagree.

Please take a moment to watch this Mayo Clinic video with Dr. Shane Shapiro in which he describes a randomized and placebo controlled, clinical trial at Mayo on the use of stem cells for the treatment of knee arthritis. These cells come from bone marrow, are re-injected on the same day, and the procedure uses your own cells, as do we at Southcoast.

If my doctor has told me NOT to have cell therapy treatments who should I believe?

Right now the world of stem cell treatments is really the wild, wild west. There are many, many providers and most may not have your best interest in mind. If your primary care physician is telling you to avoid cell therapy, the odds are that he or she is trying to protect you from some bad actors in the regenerative medicine field.

If your orthopedic surgeon surgeon has told you to avoid stem cell treatments, he or she may simply be unaware of the poor outcomes with knee replacement or the they may simply not be aware of all the advances in this new science, many of which are being published by Orthopedic Surgeons. It is interesting to note that in a 2017 article  published in the journal Stem Cell International entitled The Holy Grail of Orthopedic Surgery, Mesenchymal Stem Cells” the authors speculate that “the use of MSCs in orthopedics may transition the practice in the field (Orthopedic Surgery) from predominately surgical replacement and reconstruction to bioregeneration and prevention.” They also comment in the conclusions section that “it is important to recognize that, instead of being a distant goal in the future, the use of MSC’s (mesenchymal stem cells) already comprises a realistic option for treating several musculoskeletal diseases.”

At Southcoast Medical we believe that it is becoming more clear daily that cell therapy can treat arthritis. This applies to both spine and joint disease. We recognize that research and clinical trials are ongoing that will give us further insight into these therapies.

In this article we have recited how the former director of the FDA believes that “stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction”. We have shown that most major medical institutions have stem cell departments and that Freddie Fu and Arnold Caplan have used stem cells to grow cartilage. We have described clinical studies by Phillipe Hernigou and others that show patients prefer stem cell treatment outcomes to surgery and we have recounted the poor outcomes with traditional treatments like arthroscopy and knee replacement where many patients are left in pain. We have no doubt that cellular therapy is a viable option for joint and spine pain, but the best chance is when it is done properly. That is why we are part of the Bluetail Medical Network using data from over 50,000 such autologous procedures.

If you choose to seek cellular therapy please seek out a qualified professional who is:

  • a licensed physician
  • has experience treating joint and spine pain and will evaluate you and review your imaging studies prior to recommending cell therapy or any other treatment
  • has experience, access to data on the best type of treatments available, and an association with an extensive group of like minded physicians with whom he can discuss your care
  • is capable using image guidance for all procedure
  • will have long term follow up with you
  • will commit to using only YOUR CELLS, to give you the best chance of success at the least risk

Come see us if you have questions or contact us for more information.

843 990 8390

 

 

 

 

 

What is Involved in a Cellular Therapy Treatment?

So you are thinking about cellular therapy and you want to know what is involved.

  • Do you have to go to a hospital?
  • Will you need general anesthesia?
  • Will the recovery times be long and painful?

The answer to all of the questions is NO!

Cellular therapy treatments involve no hospital stay, no need for general anesthesia and no need for prolonged, painful recoveries.

Lets take a few minutes to explain what will be involved.

First you must be seen in office

I know this sounds crazy, but there are many clinics that “sell” stem cell treatments in a seminar setting, signing the patient up for a procedure without ever having taken a history or having done a physical exam.

Southcoast is not like that. We have board certified physicians, with much training and experience treating joint and spine disease. Our doctors will need to see and examine the patient, make sure that the issue is in fact what the patient believes it is and not something different, and then determine what option is best. It is possible that may be a recommendation for surgery.

You will need imaging studies

If you have not already had imaging studies, we may need to order x-rays or MRI. Based on your history, location of pain, and your examination, we will decide which, if any,  imaging studies are required. If you already have had such studies, then please bring them to the initial visit. If they need to be ordered, we will review them with you on your follow up visit.

Most often such studies confirm our diagnosis, and help us to be certain we are treating the proper cause of pain.  However, they may also help us decide if you are a good candidate for cellular therapy, and if so what approach is best.

We will ask you to refrain from certain medications

Prior to the procedure, we will ask you to:

  • stop taking aspirin and non-steroidal medications like motrin, well in advance
  • scrub with antibacterial soap
  • wear loose fitting clothing
  • make us aware of any allergies
  • take any pain medications or sedatives prescribed
  • STOP any blood thinners several days in advance
  • drink more water than usual

The actual procedure is done in office under guidance

For these procedures, no trip to the hospital is required.

The procedure is typically done in office, most often using ultrasound guidance.

Ultrasound is used for location of the posterior iliac crest, and subsequent aspiration of the mesenchymal cells. It is also used in shoulder, knee and hip procedures for identification of the typical landmarks, and guidance of the injections.

In some cases, such as spine procedures, you will need to be placed on a table and a Fluoroscope x-ray will be used for guidance to allow specific targeted injections in the proper disc, ligaments, or posterior column structures.  There is no pain involved in the imaging and the injections are done using local anesthesia, which minimizes discomfort.

Supraspinatus muscle in shoulder

Aspiration and injection of cells involves minimal pain

We aspirate your cells from the hip bone near your buttocks. You are most often lying on your stomach during this part of the procedure. This aspiration takes about 5-10 minutes and involves only minimal pain.

Once the cells are obtained, they must be processed. This takes about 30-40 minutes and most often you will simply be resting on the bed during this time.

After the cells are properly processed, they are injected in the appropriate areas. We use small amounts of local anesthesia prior to the injections. In some instances, such as cases of knee arthritis with subchondral edema, the cells may be combined with other agents such as bone matrix, in order to provide the best chance of success.

What happens when the injections are finished?

Once the procedure is complete, small bandages will be applied. You will be watched in the office for 30 minutes or more, then assuming you are doing well, you will be discharged home in the care of your driver. Patients are asked not to drive themselves.

You will be given contact numbers, and we will follow up with you via phone the next morning. We will see you back in the office in 3-4 weeks and will expect you to begin to gain improvement by 12-16 weeks!

Cellular therapy is a reasonable option for many causes of spine and joint pain.  Contact us and let us help you decide which approach is best for you.

How PRP helped me!

 

 

Are you considering  PRP treatments to relieve your arthritis and spine pain? Are you skeptical that this can work? Let me share with you the story of how PRP worked for me.

I grew up in a middle-class family and we rarely went to the doctor. When we did, we knew the doctor would have all the answers and be able to help. So, it was only to be expected when I entered medical school that I was anxious to be able to cure illness myself.

I spent years in medical school in basic sciences and years on hospital wards and all the while I found myself learning more and more, but after a decade of training and early practice the thing that stood out most to me was how much doctors CANNOT cure!

I participated in a variety of surgeries but saw many patients fail to improve. I watched my colleagues have the same results. I was surprised how many patients came seeking relief from arthritis and spine pain but left without help. I wondered what had happened to my childhood idea of a physician able to solve all problems and I looked for more answers.

Then some time after I entered private practice, I developed an elbow injury. I sought help but the pain and loss of function became worse and worse. At the peak of my illness I could not hold a full glass of water because of pain.

I had to stop tennis
I had to stop golf
I could not lift weights or do arm exercises
My forearm muscle mass decreased dramatically.
My life was changing, and like anyone with such an injury, I did not like the change.

I tried many treatments including:

  • using a brace
  • steroid injections
  • physical therapy
  • acupuncture

The pain always recurred. So, I finally made the decision to go ahead with surgery and guess what?

THE SURGERY WAS A FAILURE!
I WAS STILL IN PAIN AND MY FOREARM BECAME WEAKER STILL.

My pain persisted for years and I had resigned myself to learn to live with it, knowing I had tried everything.

Then one day in the hospital an orthopedist friend, Dr. John Ernst, showed me a journal article about
A WAY TO HEAL INJURIES WITH AN INJECTION OF A PATIENT’S OWN CELLS.

I was skeptical, and other doctors laughed and told me the idea was silly. I thought about options and of course knew no one who had done such a procedure, but I finally decided there was little to lose, so I asked Dr. Ernst to do the injection.

As incredible as it may seem, the injection worked!

My pain resolved.
After years of pain and a failed surgery, ALL IT TOOK WAS THE INJECTION OF MY OWN CELLS TO END MY PAIN. THAT PROCEDURE CHANGED MY PAIN AND CHANGED MY APPROACH TO MEDICINE!

Since that time
I have treated thousands of patients with spine and joint pain.
I have followed hundreds of patients with lasting pain after spine surgery.
I have seen many patients have knee replacement and be left with chronic pain.
Through it all I have searched for newer treatment options trying find some way to help.
All the while I remembered how much my elbow injury had limited me, and the seemingly simple solution that solved my problem.

SO, WHEN ARTICLES BEGAN TO APPEAR IN MEDICAL JOURNALS STATING THAT CELLS FROM OUR OWN BONE MARROW MAY HEAL ARTHRITIS AND SPINE PROBLEMS, I PAID ATTENTION, KNOWING SOMETHING SIMILAR HAD HELPED ME!

Doctors now know that the injection that cured me was really because of the incredible healing power of Platelet Rich Plasma (PRP). This is a portion of our blood that calls stem cells to help with injury! Now, years later, research has clearly shown that these cells can heal bone, cartilage, ligament and muscle. We know where these cells live in our bodies and how to capture them to use their power to stop arthritis and spine pain and heal injury. I have partnered with one of the most prominent groups in North America (Bluetail Medical with over 50,000 BMC procedures done) in order to bring the best options to my patients!

If you have arthritis or spine pain, I’m sure you too would like to learn how you can avoid surgery and still end your pain and heal your tissues using your own cells. Skepticism is normal and this may sound too good to be true, but these treatments can work! Read Dr. Hernigou’s study on knee arthritis and see how his patients preferred outcomes from cell therapy to surgery.

The online magazine Bioinformant
lists many professional athletes who have used cell therapy including: Stephen Curry, Tiger Woods,
Kobe Bryant, and Peyton Manning. These athletes could have any treatment but chose this option.

We at Southcoast Regenerative Medicine know cell therapy has incredible potential and can work.
We can help you take advantage of the incredible healing power of your own cells.

Come see us and allow our board certified physicians to hear your story, examine you and review your imaging, and then decide the best option for you.

But please, DON’T WAIT TOO LONG BECAUSE THESE TREATMENTS WORK BEST WHEN USED EARLY!

Take the advice of a physician who learned about the healing power of cell therapy when this option worked for him! Your body has a reservoir of healing cells that can stop joint and spine pain. We can show you how this can help you. CALL US TODAY 843 990 8390 or sign up for an appointment online, or even simply request more information. We want to help.

Charleston office:
3070 N. Hwy 17   Mount Pleasant, SC  29466  843 990 8390

Aiken/ Augusta office:

440 Society Hill Dr., suite 100
Aiken, SC 29803  803 226 0102

 

Autologous Bone Marrow or purchased Amniotic Products / Which is better?

Across the United States amniotic tissue products are being used and sold as “STEM CELLS”.  Several companies produce injectable amniotic products and many healthcare offices use these products with advertising suggesting they contain many millions of Stem Cells able to remedy most any problem.  In these clinics patients come in for treatment, the amniotic product is thawed and injected, and hopefully the touted treatment will solve the patient’s particular issue.  However there have been questions in both the research community at large and in the clinical field of regenerative medicine as to whether these products actually contain living stem cells.

ARE THERE REALLY STEM CELLS IN AMNIOTIC PRODUCTS?

Researchers have known for some time that amniotic fluid in living humans does contain stem cells and growth factors. The worry has been that through processing, including freezing of the samples, these cells may be damaged. Dr. Alberto Panera and several of his colleagues at the University of California Davis  published a paper in the American Journal of Sports Medicine evaluating three of these products to determine their cellular composition.

Dr. Panera and his group approached seven companies that produce amniotic products. These companies were invited to participate and submit samples to be tested, but only three did so. Those samples were analyzed for the presence of stem cells, and growth factors and these products were compared to unprocessed amniotic fluid and two separate samples of mesenchymal stem cells derived from human bone marrow aspirates.

RESULTS:

Dr. Panera and his associates were unable to identify stem cells in the commercial amniotic products tested. Mesenchymal stem cells WERE cultured from bone marrow aspirates.

Despite the lack of living stem cells in the amniotic samples, there were growth factors identified in all specimens.

Stem Cell Lab

This study does not necessarily suggest that amniotic products are unhelpful.  In fact many patients seem to have had some promising results from the use of these products and certainly the presence of growth factors suggest these products may still be a promising tool in the treatment of spine and joint disease. However, it seems clear that if stem cells are the tool you are looking for, bone marrow concentrate (BMC) is the better option in cases where that is possible.  Certainly in cases where patients have brittle bones, or other reasons why BMC is not a great choice, perhaps amniotic products are still a reasonable option.

At Southcoast Regenerative Medicine we use bone marrow concentrate in the treatment of spine and joint disease in most cases. We believe this is typically the best source for living, viable stem cells, and is also a rich source for growth factors.  We also believe patients will get a better response from BMC than from purchased, frozen amniotic products. Patients should consider this data when choosing their stem cell clinic.

In addition to the article above, there is now a podcast entitled BAD BATCH. This podcast tells the story of a bad batch of cells, which the FDA has concluded was contaminated and then distributed to several clinics, with many of the patients of those clinics suffering serious illness. A sample was analyzed and the analysis found no living stem cells.

This suggests that if patients choose to obtain stem cell treatments from the clinics that purchase these cells, those patients have two worries

  • are there any living cells in these specimens that I am planning to have injected?
  • has there been contamination during the processing of these cells that could harm me?

AT SOUTHCOAST REGENERATIVE MEDICINE WE USE AUTOLGOUS (YOUR OWN) CELLS.  MANY STUDIES HAVE SHOW THAT THERE ARE LIVING VIABLE STEM CELLS IN BONE MARROW SAMPLES. THER IS ALSO NO RISK OF CONTAMINATION DURING PROCESSING. 

COME FOR A VISIT AND LET US TEACH YOU ABOUT YOUR STEM CELL OPTIONS, AND EXPLAIN THE SAFETY AND PROVEN CLINICAL EFFECTIVENESS OF USING YOUR OWN CELLS!

 

PRP Useful in multiple applications/ including sex!

No doubt you have heard of PRP!

Platelet Rich Plasma was early on used in dental procedures for healing, and later for tennis elbow and epicondylitis.

BUT IS PRP FOR SEX TOO?……Yep!

Dr. Charles Runnels has pioneered the P shot for men and the O shot for women.  The idea of each is increased blood flow to the penis and clitoris. These treatments are incredibly simple, painless, and have shown great promise in aiding in sexual pleasure.  The O Shot may decrease urinary incontinence in women, without the surgeries and complications associated.

What is PRP and how does it help?

 

PRP is simply a fraction of your blood. But that fraction has a variety of growth factors and cytokines to nurture tissue health.

These factors include:

  • IGF Insulin-like growth factor
  • PDEGF (platelet derived epidermal growth factor)
  • PDGF (platelet derived growth factor)
  • TGF (transforming growth factor)
  • ECGF (endothelial cell growth factor)
  • VECF (vascular endothelial growth factor)
  • bFGF (fibroblast growth factor)
  • and many more

These factors help in the following ways:

  • decreasing autoimune function
  • new vessel growth
  • larger adipocytes that multiply
  • collagen production
  • new nerves
  • new fibroblasts
  • better glandular function

So What does all this mean?  What applications are best suited for PRP?

 

PRP has been shown to be effective in a variety of conditions.  The most common are golfer’s and tennis elbow, but there are many more including:

  • Tendonitis, like achilles (ankle) and patella (knee)
  • Major joint arthritis (knee, hip arthritis)
  • Partial rotator cuff tear
  • Plantar fasciitis (foot pain)
  • Hair loss (see video with Dr. Jennifer Ashton from “The Doctors” TV show)
  • Vampire facials for better skin
  • Scar tissue
  • Treatment of lichen sclerosus
  • Treatment of dypareunia (pain in vagina with sex)
  • Peyronie’s disease in men
  • Erectile dysfuntion
  • Stress incontinence in women
  • Interstitial Cystitis
  • Nerve repair
  • sexual dysfunction in women

The Truth about PRP

PRP is proving to be helpful in a variety of applications. It has shown incredible promise, and along with Bone Marrow Concentrate, is the cornerstone of biologic treatments for musculoskeletal disease today.

PRP is less expensive than many other options and has almost no risk. The cells (coming from the patient themselves) are very unlikely to cause problems. The use of PRP in sexual dysfunction, cosmetics and hair loss is a reasonable extension of its use in dental and orthopedic procedures. PRP is an incredible, safe, reliable product that harnesses the bodies own healing powers, and can fix a variety of problems.

No doubt, in the future, we will see a greater use of PRP in even more applications.