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.
Insurance Corporate Medical Policy- Orthopedic Applications of Stem Cell Therapy

Insurance Corporate Medical Policy- Orthopedic Applications of Stem Cell Therapy

Description of Procedure or Service

Mesenchymal stem cells (MSCs) have the capability to orchestrate cell differentiate into a variety of tissue types, including various musculoskeletal tissues. Potential uses of MSCs for orthopedic applications include treatment of damaged bone, cartilage, ligaments, tendons and intervertebral discs. Stimulation of endogenous MSCs is the basis of procedures such as bone marrow stimulation (e.g., microfracture) and harvesting. Bone marrow aspirate is considered to be the most accessible source and thus the most common place to isolate MSCs for treatment of musculoskeletal disease. The U.S. Food and Drug Administration (FDA) has stated that cell-based therapies are one of the most rapidly advancing approaches intended to repair, replace, restore, or regenerate cells, tissues and organs

While concentrated autologous MSCs do not require approval by the U.S. Food and Drug Administration (FDA); Mesenchymal stem cell therapy is considered investigational for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue. Since as of this writing, the Corporate Insurance world does not cover investigational services or procedures, Cellular Orthopedic interventions are not indemnified. It is a self pay undertaking.

The use of mesenchymal stem cells (MSCs) for orthopedic conditions is an active area of research. Despite this research into the methods of treatment, there are uncertainties regarding the optimal source of cells and the delivery method. Current available evidence on procedures using autologous bone-marrow-derived mesenchymal stem cells (MSCs) for orthopedic indications in humans consists primarily of case series and small non-randomized comparative trials with insufficient data to evaluate health outcomes. In addition, expanded MSCs for orthopedic applications are not FDA approved (concentrated autologous MSCs do not require FDA approval). Due to the lack of evidence that clinical outcomes are improved and the lack of regulatory approval, use of stem cells for orthopedic applications is considered investigational.

The above is in part taken from information to be found by searching Corporate Medical Insurance Policy via the internet. As you are aware if you are a reader of this Blog or as you will become aware after reading this Blog, the members of the Regenexx Network are gathering outcomes data that could result in a future change of Corporate Indemnification Policy for Regenerative Medicine. Actually, a corporate policy review for BCBS is scheduled next month.

In the mean time, a mailing from the AARP last week put everything into perspective and it came as an offering from AARP-Advantages having to do with protection for your pet, Petplan. “Every six seconds a pet parent is faced with a vet bill for more than $3,000.”  What follows are some of the costs associated with your pet, the cost of caring:

Ear Infection—– ————–$4,048

Hip Dysplasia——————-$9,808

Ingestion of foreign body—-$9,389

Periodontal disease————-$2,651

Motor vehicle accident——-$11,695

I think you get the message. It is my job to make sure you get as good care and as good an outcome as you seek for your pet and we certainly cost less.   847 390 7666 to schedule appointment

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Is a lower function score after a Cellular Orthopedic intervention because of your lumbar spine?

Although Orthobiologics and Cellular Orthopedic interventions generally result in excellent pain relief and return to or maintenance of a high degree of function, approximately 20 percent of patients have persistent functional deficits that affect their quality of life as I have learned after review of three and a half  years of Regenexx procedures for the hip and knee.

It looks as if lumbar spine problems are a common cause of functional disability in patients presenting with hip and knee arthritis. While, I didn’t perform a particular study, in reviewing those with less than optimal outcomes from my first three plus years of Regenerative Medical procedures, I observed that patients with a prior history of lumbar spine problems had significantly worse hip and knee functional scores when compared to the majority who did well and had no documentation of a preexisting spinal abnormality.

The results of my observations mirror multiple previous studies that have found poor pre operative and post operative knee and hip function in patients undergoing a joint replacement who had a spinal degenerative co-morbidity. Through the review of our data base, we have identified the problem. Now I must determine the alternatives in dealing with the problem. First of all, from here on out, all new and returning patients will be questioned about their back related symptoms; and when deemed appropriate, images will be requested. If a significant degenerative disc or joint process is identified then the patient will be appropriately advised and referred for timely intervention. As of this writing, the options are either classical pain management or surgical in nature. The good news is that included in classical pain management for the spine is a very successful approach focusing on weight reduction, Pilates core strengthening, and Tai Chi, yoga or stretching. The failure of these non operative approaches is based on the failure of a patient to commit three or four days a week. The next level of pain management is injection based. Historically, an epidural series has been the standard but more recently, Regenexx introduced PRP as a safer and longer lasting approach. As of this writing, Regenexx and others have introduced intradiscal procedures, but I want more outcomes before I recommend such.

As far as what I do for arthritis, there will be more attention to devoted to the patient’s back when we do the intake for an arthritic joint. On the other hand, we do have several improvements and additions in our ever evolving menu of services for the arthritis hip and knee. To learn more, schedule a consultation:

847 390 7666

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Hamstring injuries and Regenerative Medicine

Hamstring muscle injuries — such as a “pulled hamstring” — occur frequently in athletes. They are especially common in athletes who participate in sports that require sprinting, such as track, soccer, and basketball. A pulled hamstring or strain is an injury to one or more of the muscles at the back of the thigh. Most hamstring injuries respond well to simple, nonsurgical treatments. In this Blog however, I am not focusing on “athletes”, I am raising concern about an epidemic of significant hamstring injuries, as I see it, in middle aged fitness enthusiasts who are seeking consultation in my office.

The hamstring muscles run down the back of the thigh. There are three hamstring muscles:

  • Semitendinosus
  • Semimembranosus
  • Biceps femoris

They start at the bottom of the pelvis at a place called the ischial tuberosity. They cross the knee joint and end at the lower leg. Hamstring muscle fibers join with the tough, connective tissue of the hamstring tendons near the points where the tendons attach to bones. The hamstring muscle group helps you extend your leg straight back and bend your knee.

A hamstring strain can be a pull, a partial tear, or a complete tear. Muscle strains are graded according to their severity. A grade 1 strain is mild and usually heals readily; a grade 3 strain is a complete tear of the muscle that may take months to heal. Most hamstring injuries occur in the thick, central part of the muscle or where the muscle fibers join tendon fibers. In the most severe hamstring injuries, the tendon tears completely away from the bone. It may even pull a piece of bone away with it. This is called an avulsion injury.

Muscle overload is the main cause of hamstring muscle strain. This can happen when the muscle is stretched beyond its capacity or challenged with a sudden load. Hamstring muscle strains often occur when the muscle lengthens as it contracts, or shortens. Although it sounds contradictory, this happens when you extend a muscle while it is weighted, or loaded. This is called an “eccentric contraction.”  Restated, several contributory factors have been proposed as being related to injury of the hamstring musculo-tendinous unit. They include: poor flexibility, inadequate muscle strength and/or endurance, dyssynergic muscle contraction during running, insufficient warm-up and stretching prior to exercise, awkward running style, and a return to activity before complete rehabilitation following injury. I am currently investigating Platelet-rich plasma (PRP) for its effectiveness in speeding the healing of hamstring muscle injuries. PRP is a preparation developed from your own blood. It contains a high concentration of proteins called growth factors that are very important in the healing of injuries. For the avulsion, Bone Marrow Concentrate may obviate the need for surgery.  For more information 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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Insurance Corporate Medical Policy- Orthopedic Applications of Stem Cell Therapy

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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