Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.

What’s ahead in Cellular Orthopedics for 2016

The Regenerative Medicine Menu

  • Hydrocortisone
  • Hyaluronic Acid (HA)
  • Platelet Rich Plasma (PRP)
  • Amniotic Fluid Concentrate (AFC)
  • Bone Marrow Aspirate Concentrate (BMAC)
  • Regenexx-SD Procedure
  • Simple Adipose Graft
  • Stromal Vascular Fraction (SVF)

 

The human body posses a remarkable capacity to heal. Following tissue damage or disease, the body’s immune response coordinates a sequence of events to fight off harmful disease or infections and repair the damaged tissue. While scar tissue may form as a byproduct of rapid healing, scar tissue may be remodeled over time. This is the Normal Healing Response. The goal of regenerative therapies is to modulate these stages of healing be it soft tissue, cartilage or bone.

As a response to the delisting by the AAOS of Hyaluronic Acid from the osteoarthritis armamentarium, industry has attempted to fill the void with Amniotic Fluid Concentrate. For those unfamiliar, when a pregnant woman schedules a C-Section, she is approached about “donating” her amniotic fluid that may be recovered at the time of the procedure. During the course of the pregnancy, the potential donor is screened for communicable diseases. There is little if any immuno-rejection phenomenon and the AFC has growth factors, anti-inflammatory cytokines and Hyaluronic acid all in high concentration. While there are large numbers of stem cells deposited by the fetus and the placenta during the course of the pregnancy, by time the Amniotic Fluid is concentrated, processed, frozen for preservation and finally fast thawed for usage, little in the way of viable stem cells may be observed. Never the less, the AFC has great potential in the arthritic setting; and when micronized, is a marvelous adjunct in effecting wound healing for the diabetic and wound that won’t heal.

At our Regenerative Pain Center, we have observed over 40 different interpretations for the term PRP. The problem is that there is no standard of concentration, quality or quantity. To that end, an attempt is underway to reach accord on an actual standard definition. Then there comes the dilemma of whether the PRP is best when leukocyte free or not. Next comes the argument to support Platelet Poor Plasma (PPP). In our practice, we alter the formula according to the needs of the patient.

You will note at the get go, the repeat Bone Marrow Aspirate Concentrate bullets. There is bone marrow aspirate concentrate and then there is the Regenexx -SD approach. The latter is what has been so effective in our practice for three and a half years; so much so that it is what I truly believe in for moderate osteoarthritis and even advanced in certain settings.

While “simple” adipose grafts are heavily marketed, let me refer you to Pope Brock’s Charlatans, first published in 2008 to understand my view of how plastic surgeons are victimizing patients by including the management of arthritis in their cosmetic approaches. Last of all is the new introduction of the Stromal Vascular Fraction following the micro-fracture of fat graft. The latter became available in the US in mid summer, 2015. Clinical trials are in progress. If you want to delay or possibly avoid a joint replacement for arthritis, call for a consultation     847 390 7666

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Accuracy, Ethics and Corrections

The last Blog posted in 2015 indicated that I wouldn’t look back; but after its posting, I received this correction form Dr Chris Centeno, arguably, the best informed Regenerative Medicine expert in the North America.

“Mitch,

The discussion of amniotic injections isn’t correct. We found that amniotic tissue hurt stem cells. While we did find a weak growth factor/cytokine effect, it was less than PRP. So extrapolating that data, it would be stem cells>PRP>amniotic. Please correct.

Chris”

I very much appreciate his input as well as invite his ongoing constructive criticism, additions and recommended corrections. Let me add, the PRP he is referring to is not the usual and customary office based 15 minute procedure; but rather a proprietary process developed in the Regenexx laboratories and available from those physician members of the Regenexx network.

 

Changing my focus, in a review article appearing in the January 2016, volume of the Journal of the American Academy of Orthopedic Surgeons, an article appeared Risk Prediction Tools for Hip and Knee Arthroplasty. It is easier for me to quote rather than extrapolate:  “After arthroplasty, complications such as infection, venous thromboembolism, acute myocardial infarction, pneumonia and many others are associated with poorer patient outcomes and represent a substantial cost burden to the American healthcare system”. The article continues: “Total joint arthroplasty is thus an appropriate target for quality improvement and cost containment via pay-for-performance initiatives.” For someone such as myself, an orthopedic surgeon who devoted a 37 year career after nine years of post graduate education and training performing Total Joint Replacements, I feel that my professional evolution into cellular orthopedics is again validated.  In reviewing our data base, following a cellular orthopedic intervention for arthritis, we have not recorded one infection, venous thromboembolism, acute myocardial infarction, case of pneumonia, or any other complication. While 100% of my patients do not experience a successful or satisfactory outcome following the first cellular orthopedic intervention for arthritis, those numbers increase from 75% to 85% with a booster or repeat procedure. Once again, the end result of an unsuccessful Total Joint Replacement is a revision surgery; after a revision, it was not unusual to hear a patient volunteer “give me back my arthritis”. After a less than optimal outcome of a cellular orthopedic intervention, the fallback position is a repeat procedure followed by a patient’s “thank you doctor.”

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Final Blog of 2015

Final Blog of 2015

I won’t look back so let’s see what’s coming in 2016. The clinical Regenexx Knee Trial introduced in 2014 will start providing information here-to-for unavailable in Cellular Orthopedics. Many times in the last several years I had written about my observation that there is a paucity of science and a plethora of marketing without support in the world of Regenerative Medicine. Last week, a patient came to my office for a second opinion after having attended a seminar on amniotic fluid concentrate. The patient had carried away a notion that amniotic fluid concentrate contains viable stem cells that will regenerate an arthritic knee. Several months ago, I had reviewed the subject in my Blog after having attended the first Interventional Orthopedics Foundation meeting in Broomfield, Colorado. After extensive testing in a laboratory setting, it was documented that while there may have been stem cells in the amniotic fluid when recovered, by the time the material was processed, frozen, and fast-thawed, the amniotic fluid commercially available has no regenerative potential. The role of amniotic fluid concentrate in 2016 will be to replace visco-supplementation in the marketplace as more and more insurance carriers will withdraw coverage based on publications from the American Academy of Orthopedic Surgeons on the benefit or lack thereof from visco-supplementation. If there are no stem cells in the amniotic fluid concentrate, what is there that may be helpful? The scientific laboratory studies did confirm that the Growth Factors and anti-inflammatory cytokines do survive processing and may be of equal or even greater importance in the long run than the stem cells. My plan is to replace visco-supplementation with amniotic fluid by mid 2016 in my practice.

I want to return to our Regenexx Knee Clinical Trial. It is the largest of which I am aware in the world as far as the methods used in determining the success of a stem cell intervention for Grades Two and Three Osteoarthritis of the knee. I was chosen to execute this three to five year outcomes study because of my background as director of the joint replacement program at Rush, one of the five largest joint replacement programs in the country. In addition, over my 40-year joint replacement career, I had published many studies on the outcomes of a hip and knee replacement at five and ten years. Our preliminary observations concerning those who met the trial inclusion criteria are that the vast majority, are very satisfied and active. Certainly, we will have to wait another year before our numbers allow for statistical analysis; but so far, the outcomes are excellent. Please keep in mind the methodology for the intervention is not a single injection but rather a carefully designed treatment program. To learn more, call for a consultation

847 390 7666 with offices in Des Plaines and Lincoln Park

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Final Blog of 2015

Realistic Patient Expectations

The December 2015, Journal of the American Academy of Orthopedic Surgery, featured a Review Article titled Establishing Realistic Patient Expectations Following Total Knee Arthroplasty. The abstract begins with the following sentence “nearly 20% of patients are dissatisfied following well-performed total knee arthroplasty with good functional outcomes.” It continues, “surgeons must understand the drivers of dissatisfaction to minimize the number of unhappy patients following surgery.” There are several studies that have shown unfulfilled expectations are a principal source of patient dissatisfaction following a joint replacement including a failure to relieve pain, improve walking ability, return a patient to sports, and improve psychological well-being. In my previous career as a joint replacement surgeon, it became all too apparent that patients were overly optimistic with regard to expected outcomes following surgery. Published data on clinical and functional outcomes following joint replacement show that persistent symptoms such as pain, stiffness, and failure to return to preoperative levels of function, are common and normal. I thought I should repeat realistic expectations after a Bone Marrow Aspirate/Stem Cell intervention for an arthritic joint based on my data over three and a half years of said procedures for arthritis allowing you to decide which is the next best procedure for you.

First and foremost, the fall back position of an unsatisfactory Bone Marrow Aspirate/Stem Cell intervention at any joint is a repeat procedure for which we have supporting data that a second intervention actually does better than a first. Compare the latter to the rescue of a failed or unsatisfactory joint replacement, a complex major surgical procedure called a revision. The outcome of a repeat Bone Marrow Aspirate/Stem Cell intervention is a better result. Compare that to the outcome of a revision hip or knee replacement; namely, a better X-ray, Even though we have experiencing higher than average temperatures in the Midwest for now, my thoughts turn to skiing. My patients, who have undergone a stem cell procedure with arthritic hips and knees are either on the slopes or headed that way. While after a hip replacement, I will admit that some patients return to the slopes, almost none do so after a total knee prosthesis. After a revision hip or knee, forget it and plan for a cane.

While the world of joint replacement surgery is really not changing, what has been still is; I am able to get you on the slopes or at least relieve your pain with a needle and not a knife without burning any bridges. Joint replacements have a place for advanced arthritis; although Cellular Orthopedics may even now help grade four osteoarthritis.   To learn more about realistic expectations and avoid disappointment following a total joint replacement, call for an appointment      847 390 7666

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Final Blog of 2015

When deciding if you should undergo a stem cell procedure, it takes an office

To determine if your quality of life may be improved by a Cellular Orthopedic intervention, a look at an X-ray or MRI is not the answer; a physical examination or several assessments may be needed in addition to reviewing an image.

In a Study: Hip pain and radiographic OA may not correlate reprinted in AAOS Headline News Now-December 4, 2015, Data from a study published online in the journal The BMJ suggest that hip pain and radiographic OA may not correlate in some patients. The research team assessed pelvic radiographs for hip OA among two cohorts: the Framingham Osteoarthritis Study and the Osteoarthritis Initiative. They found that in the Framingham study (n = 946), 15.6 percent of hips in patients with frequent hip pain displayed radiographic evidence of hip OA, while 20.7 percent of hips with radiographic hip OA were frequently painful. In the Osteoarthritis Initiative study (n = 4,366), 9.1 percent of hips in patients with frequent pain displayed radiographic hip OA, and 23.8 percent of hips with radiographic hip OA were frequently painful. The research team writes that hip pain was not present in many hips with radiographic OA, and many painful hips did not show radiographic hip OA. Thus, the evidence suggests that in many cases, hip OA might be missed if diagnosticians rely solely on hip radiographs.

In yet another article featured in the same publication

Study: Worsening lesion status may predict higher risk of knee OA.

According to a study published online in the journal Annals of the Rheumatic Diseases, worsening lesion status as determined via magnetic resonance imaging (MRI) may predict a significantly higher risk of developing knee osteoarthritis (OA) or painful symptoms for patients with at-risk knees. The researchers used MRI to assess cartilage damage, bone marrow lesions (BMLs), and menisci at 12 months (baseline) and 48 months for 849 participants in the Osteoarthritis Initiative who had been determined to be Kellgren-Lawrence Grade-0 in both knees. They found that from baseline to 48-month status, worsening of cartilage damage, meniscal tear, meniscal extrusion, and BMLs was associated with concurrent incident radiographic OA and subsequent persistent symptoms. The researchers write that the findings suggest that such lesions may represent early stages of OA.

In this Blog, I am giving you some of the scientific basis for my reasoning that you allow me to complete a physical examination before I advance a therapeutic recommendation. You may also better understand why one intervention alone may not be the answer as arthritis silently progresses and may not necessarily allow for predictability. It takes an office visit or two or three and maybe yearly to help a patient enjoy the highest quality of life and a menu of services starting with a cortisone injection, next visco-supplementaion and ultimately, stem cell intervention. Some years down the line, that stem cell intervention may need to be repeated.

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