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.

An exclusive interview with a Cellular Orthopedic Pioneer

While skiing last week in Vail, Colorado, I had the opportunity to sit down with Mitchell Sheinkop, MD, Fellow of the American Academy of Orthopedic Surgery and Fellow of the American College of Surgeons, to learn about the emerging field of Interventional Orthopedics. In 2007, Dr Sheinkop received the Shaare Zedek International Humanitarian Award in recognition of his global orthopedic educational endeavors.
Question: Do stem cells really work?
Answer: There is a misconception regarding joint restoration as it is not the adult mesenchymal stem cell alone that is responsible for postponing or even avoiding a joint replacement in the arthritic setting.

Question: All I read and hear about are stem cells?
Answer: Unfortunately, ad placement hype is competing with good science for the patient’s attention and owing to advertising and marketing; the real message may be getting lost.

Question: Would you please explain?
Answer: When I “graduated” from a knife to a needle, I too believed that it was the stem cell that would morph into cartilage. We now know that the Adult Mesenchymal Stem cell orchestrates the regenerative process and directs other cells and molecules to help reverse the arthritic process, effect healing and improve function.

Question: Who are the members of the orchestra, so to speak?
Answer: When injury occurs, platelets aggregate to initiate the healing process. The activated platelet recruits the cells lining capillaries (pericytes) that then function as stem cells. Control of the bio-immune response and the regeneration affected by anti-inflammatory molecules termed Cytokines and cellular secretions known as Growth Factors are directed by the stem cell.

Question: Where do all of these stem cells, cytokines and growth factors come from?
Answer: When it comes to the musculoskeletal system, we look to the patient’s own Bone Marrow Aspirate Concentrate as the only FDA tolerated resource .While you may be aware of the potential of adipose tissue as a stem cell resource, in order to liberate the stem cell, fat has to be digested with an enzyme, collagenase. As of this interview, enzymatic digestion is not approved by the FDA nor are there significant scientific studies to support adipose derived stem cells for arthritis.

Question: I am aware of plastic surgeons offering fat graft for arthritis, is it effective and legal?
Answer: Neither but it is expensive. Fat graft is not a source of regeneration; it is filler for cosmetic surgery.

Question: I am aware of a media blitz promoting Amniotic Fluid Concentrate as a source of stem cells?
Answer: The research at the Interventional Orthopedic Foundation demonstrated that while there are stem cells in amniotic fluid along with Hyaluronic acid, anti-inflammatory Cytokines, and Growth Factors when that fluid is harvested in conjunction with a Cesarean section; after processing, freezing and the quick thaw, there are few if any viable stem cells remaining.

Last Question: How might a patient seeking to manage arthritis without surgery make the right therapeutic decision?

Answer: Just as our presidential campaigns, paraphrasing Dahleen Glanton in the Chicago Tribune, Monday, February 22, are a cesspool of empty promises and lies, so too is the marketing of stem cells; witness the advertisement featuring a chiropractic spokesperson in The Chicago Tribune, Tuesday, February 9, 2016, placed by The Stem cell Institute of America.

When you seek a Regenerative Medicine consultation, make sure that physician is fellowship trained, board certified and integrates clinical research with his or her practice.  Don’t depend on anecdote; inquire about outcomes data. In my practice as well as in those other members of the Regenexx Network, we base our clinical decisions and therapeutic recommendations for Cellular Orthopedics on Documented Results.

Mitchell  Sheinkop, MD  accepted Emeritus Professor status as the director of the joint replacement program at Rush University Medical Center six years ago where he had played a major role over 37 years in the development of the department of orthopedics and in the founding and growth of Midwest Orthopedics. Since that time he has played a major role in the emerging field of Interventional Orthopedics.

 

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Stem cells and Statin recommendations during stem cell procedures

Owing to the broad indications for statin medications, an ever increasing number of patients are using these therapies. Certainly, there is a benefit to statin use as a means of decreasing cardiovascular disease; but by the same token, there is the observation of decreased athletic performance, muscle injury, myalgia (muscle pain), joint pain, and fatigue. The type of statin, the dose, drug interactions, genetic variants, coenzyme Q10 deficiency, vitamin D deficiency, and underlying muscle diseases are among the factors that may predispose patients to intolerance of statins.  When it comes to those seeking Cellular Orthopedic interventions, their fitness and exercise endeavors may result additionally in an intolerance of the combined approach decreasing and treating cardiovascular disease.

Although in general, statins are well tolerated, they can affect skeletal muscle producing symptoms that range from myalgia (muscle pain) to creatine phosph kinase (CPK)-muscle enzyme marker- elevation and rhabdomyolysis (rapid breakdown of skeletal muscle). These statin associated musculoskeletal side effects can be exacerbated by physical activity. Now comes a recently published study reinforcing previous findings that certain types of cholesterol lowing drugs called statins, inhibit Mesenchymal Stem Cells. As you know, MSCs are the body’s reservoir of regenerative potential and are capable of orchestrating regeneration of a wide variety of skeletomscular tissue. In the laboratory and now documented in patients, statins not only interfere with MSC function, the drug increases the aging and death rate of Adult Mesenchymal Stem Cells.  Basically, statins are a kind of stem cell poison.

It is important for you, the potential patient to understand that those undergoing a bone marrow aspirate concentrate intervention for arthritis are not only receiving stem cells. The bone marrow concentrate contains in addition to the mesenchymal stem cell, a category of anti-inflammatory molecules called Cytokines and another category of cellular messengers termed Growth Factors. Recent science suggests that latter two groups may be equally or perhaps more important than stem cells in introducing pain relief, increased motion, improved function and reversal of the arthritic progression.

For those of you considering a Bone Marrow Aspirate Concentrate procedure for an arthritic joint, please don’t act without discussing the use of statins with your physician. Strategies include a reassessment of the need for statin prescription, a decrease in dosage, a change to a hydrophilic statin, a statin holiday prior to and after the Cellular Orthopedic intervention followed by a rechallenge after six weeks, vitamin D replacement, coenzyme Q10 supplementation and/ or L-carnitine supplementation.

There are alternatives for those who are statin dependent  and in whom a holiday might be contraindicated.  To learn about our full menu of Cellular Orthopedic options, make an appointment

847 390 7666

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Stem Cells and Basic Science

Every week, I receive updates via brochures and journals concerning the clinical and basic science orthopedic research being done around the country at the various university medical centers. I like to read them to understand how Cellular Orthopedics is emerging and is being accepted in academic institutions. When I retired  from Rush and joint replacement surgery five years ago, my colleagues had a very jaundiced view of my new endeavors telling me and then  my patients that Regenerative Medicine was unproven, was ten years away, and was not a reasonable alternative to a joint replacement. It is with great pleasure that I am able to announce the American Academy of Orthopedic Surgery Surgical Skills update will include a three day course next month on Articular Cartilage Restoration: The Modern Frontier, as a continuing educational initiative. The title of one particular lecture really caught my attention Move-Over PRP/Viscosupplementation: Stem cells are in and why.

Taking it a step further, the latest bulletin from Jefferson Medical College’s department of orthopedic surgery reviews the basic science being done in the Laboratory of Theresa Freeman, PhD, Associate Professor of Orthopedic Surgery. “The development of Osteoarthritis can often be attributed to a trauma that occurs in youth, which begins the slow degeneration of cartilage. By reducing cartilage damage immediately after an injury, the development of osteoarthritis can be dramatically slowed.”

I have been making the case for an affirmative stem cell intervention every time an anterior cruciate surgical repair takes place or for that matter, when an individual undergoes an arthroscopic procedure. Two weeks ago, I completed a Bone Marrow Aspirate Concentrate Stem cell procedure three weeks after a young middle aged man had undergone micro fracture for a cartilage defect on the weight bearing part of his femur at the knee. On Friday, I scheduled a 72 year old gentleman for a stem cell procedure ten days after he had undergone arthroscopic surgery for a degenerative tear of his medial meniscus during the course of which degenerative changes were documented in the weight bearing zone at the inner compartment of his knee.

A webinar is scheduled by the American Academy of Orthopedic Surgeons next month in order to introduce its orthopedic membership to what may be possible through Cellular Orthopedics. I have already advised you about the Continuing Education Course next month on Articular Restoration. The orthopedic academy membership is only now being introduced to what I have been practicing for almost four years. There are now close to 750 patients in my data base who have undergone Cellular Orthopedic procedures for arthritic joints to relieve pain, increase function and avoid, certainly postpone a joint replacement. On Saturday, I am headed out to Colorado to ski with family for a week. For readers of my blog, you may recall I have undergone a regenerative procedure for my left knee. While I am realistic and I don’t dwell on being who I used to be, I believe anything is possible at any age. If you want to continue or possibly return to skiing, biking, hiking, climbing, fly fishing, skating, fitness, etc, and the limitation is arthritis, schedule a consultation

 847 390 7666

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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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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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