Stem Cell Therapy for Arthritis and Joint Injuries

In Cellular Orthopedics, New Doesn’t Necessarily Mean Better

Mitchell B. Sheinkop, M.D. — Thu, 16 Mar 2017 18:36:52 +0000

As most readers of this Blog already know, for more than 37 years, I was a reconstructive joint replacement surgeon at a major Chicago medical center, where I served as the director of the joint replacement program. I retired as emeritus professor seven years ago; after having pioneered the integration of a clinical practice with joint replacement research and education. While I had completed over 20,000 hip and knee replacements during my career and played a major role in authoring over 85 major orthopedic publications, one of the highlights of my career was the recognition by the resident staff of awarding me the teacher of the year award in orthopedic surgery. At the same time, I had the opportunity to share my joint replacement knowledge around the world. I addition, many orthopedic surgeons from across the globe would come to observe and learn my techniques. One such group came from Norway. What I learned from them during their visit was that no procedure would be allowed within the scope of the government health care system for which there wasn’t a ten-year outcome data base. Their health care system wouldn’t pay for that which didn’t have a track record and for which there wasn’t safety and efficacy studies.

I am continually amazed at the epidemic of web sites promising regenerative medicine treatments for which there is no data of success and for which there are no safety and efficacy studies. This false news seems to be an increasingly common phenomenon; more bothersome though are anecdotal outcomes cited in media placements without a scientific foundation. Last week, a major news outlet focused on a patient who had received stem cells in amniotic fluid. The hospital PR division scored a major success by placing the ad; but the Television Channel that broadcast the story apparently failed to do any independent scientific investigation to support the claims of living stem cells in commercially available amniotic fluid concentrate. The center behind the placement and the physician involved must have been influenced by the false news now commonplace; namely, amniotic fluid has living stem cells when concentrated, sterilized, irradiated, cryopreserved and fast thawed. Certainly, the video of the patient climbing stairs was a tribute to the success of the procedure; however, the success of unknown duration had nothing to do with the claim that the end result was based on regeneration attributable to stem cells.
Amniotic Fluid Concentrate has good things in it but not viable, living stem cells and there is no regenerative potential. I am able to so state as I am the principal investigator in a national ongoing amniotic fluid clinical trial to determine safety, efficacy, duration of effect and appropriate dosage.

To schedule an appointment call (312)475-1893
To visit my web site go to www.sheinkopmd.com
To watch my webinar visit www.ilcellulartherapy.com

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The tale of two people with arthritic knees

Mitchell B. Sheinkop, M.D. — Mon, 13 Mar 2017 21:34:30 +0000

It came to pass over the last several weeks that I had contact with two separate patients; one in my office and one by e-mail inquiry. Both individuals had, prior to treatment, roughly the same levels of arthritic impairment. Both with grade three arthritic knees, were similar in age, weight, height and previous levels of activity. The e-mail contact presented with a history of having undergone a total knee replacement two years earlier. The outcome was a swollen, painful and stiff knee leading to a repeat surgery (revision) one year later. Because of persistent pain, swelling and stiffness, a recent knee aspiration had been completed leading to the diagnosis of an infection. The email inquirer indicated that his orthopedic surgeon and infectious disease consultant had recommended surgical removal of the prosthesis, placement of an antibiotic impregnated cement spacer for three months during which time a pic line would allow for a three-month continuum of intravenous antibiotics. There after assuming repeat cultures of the joint would be consistent with elimination of the infection as well confirmed by a normal Erythrocyte Sedimentation Rate, C-Reactive Protein and White Blood Cell Count, yet a fourth surgery would allow for another attempt with a Total Knee Prosthesis. All this assuming the infection had been eradicated. Space does not allow for the options if all of the above measures were to fail.

Turning our attention to the second patient who had undergone a Bone Marrow Concentrate/Stem cell intervention as contrasted to the surgical approach, he had recently returned from a second week of helicopter skiing. While it is true that he couldn’t ski eight hours a day for seven straight days, he had enjoyed a great week with friends and his daughter even if he had skied only two full days and four half days. This is his third consecutive year of helicopter skiing made possible by the Bone Marrow Concentrate/Stem Cell intervention he had undergone three and a half years ago.

Certainly, there is a time and place for a joint replacement; but the saga in my first paragraph reviews only some of the risks inherent in said surgery. On the other hand, a Cellular Orthopedic intervention in my experience carries a very minimal risk. In over seven hundred procedures in the last four and a half years, I have not found an infection. Certainly, every patient doesn’t go helicopter skiing after the procedure; our outcomes data clearly documents a return to or continuation of a very active lifestyle after a cellular procedure for an arthritic joint.

To schedule an appointment call (312)475-1893
To visit my web site go to www.sheinkopmd.com
To watch my webinar visit www.ilcellulartherapy.com

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An exclusive interview with Interventional Orthopedic Surgical pioneer Mitchell Sheinkop, MD, (continued)

Mitchell B. Sheinkop, M.D. — Mon, 06 Mar 2017 17:50:24 +0000

Blog: Dr. Sheinkop , let’s pick up where we ended at the last interview. You were going to tell us about the hip labrum?

Sheinkop: Recently, there has been an increased frequency of diagnosis pertaining to an acetabular labral tear when a patient presents to a physician with groin pain. The cause may be attributed to trauma or it may be spontaneous in nature. While only an orthopedic surgeon really understands how to properly examine the hip joint, I am observing the next step in every and all patients with “hip” or “groin” pain is an MRI prescription. While a torn acetabular labrum is best diagnosed on the MRI after arthrogram, even that exercise may not result in a proper diagnosis. There are anatomic variants that are frequently mistakenly diagnosed as a tear and there are positive findings for a labral tear that when surgically addressed do not result in clinical improvement. In general, unless there are mechanical signs such as snapping, clunking or giving way, pain alone is not justification for arthroscopic hip surgery. In the presence of arthritis, arthroscopy is almost never indicated in the new world of evidence based medicine.

Blog: If I am not mistaken, the way you responded to the labral question is how you have responded in the past to a “positive” MRI of the knee and a diagnosis of a torn meniscus (cartilage).

Sheinkop: You are correct. The scientific evidence clearly identifies the fact that a pain generator must be identified before a surgical procedure. Even if the MRI is compatible with a torn labrum or meniscus, in the presence of arthritis, arthroscopic surgery will make things worse over six months. Surgery in said circumstances should be reserved for mechanical symptoms and not pain.

Blog: Then what is a patient with pain in the groin or knee to do?

Sheinkop: First and foremost, my job is to identify the cause of the pain and treat the patient, not the image. In the absence of clunking, snapping and giving way (joint instability), Interventional Orthopedics based on Platelet Rich Plasma and Bone Marrow Aspirate derived stem cells and growth factors provide the surgical alternative-remember the needle and not the knife.

Blog: I learned this week that you have been invited to St. Petersburg, Russia, this September to present non surgical alternatives for arthritis, at an international orthopedic meeting focused on joint replacement.

Sheinkop: Your information is correct. The role for Interventional and Cellular orthopedics, basically regenerative medicine, is in grades two and three osteoarthritis; while a patient is quite functional and not yet sufficiently impaired to justify the risks inherent in a joint replacement. On the other hand, there is a large patient population with advanced osteoarthritis of a major joint wherein the joint replacement option is to great a medical challenge and may risk survival. The evidence I have gathered over almost five years is not only of interest in the United States but has global potential impact.

To learn more call (312) 475-1893 to schedule a consultation
View my web site at www.sheinkopmd.com
Watch my webinar at www.ilcellulartherapy.com

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Don’t be fooled by bogus stem cell claims

Mitchell B. Sheinkop, M.D. — Tue, 28 Feb 2017 01:24:12 +0000

When it comes to cellular orthopedics, for me, it is a matter of honor and self-interest.

If you aren’t aware of the bogus stem cell claims or “false news”, read the LA Times article that appeared last week http://www.latimes.com/business/hiltzik/la-fi-hiltzik–oz-stem-cell-20170213-story.html

The article followed a Dr. Oz television expose where he focused on charlatans victimizing the public with false information at extremely outrageous fee schedules. The egregious behavior stemmed (no pun intended) from mostly California based clinics but Texas was another state exposed. For those who read this Blog, you are familiar with the false advertising of “Stem Cell Clinics” highlighting regenerative medicine via Amniotic Fluid for arthritis in Illinois, that I have repeatedly taken to task. To repeat, while there may be living cells when amniotic fluid is harvested, following collection, processing, sterilizing, irradiating, freezing and fast thawing, there are no living or viable stem cells in the pat being offered as a regenerative alternative. Dr. Oz took his expose a lot further calling attention to false claims without medical evidence wherein the so called regenerative medicine clinics he exposed offer treatment for every and any affliction of the human body.

Since the innovations introduced by Regenexx 10 years or so ago, interventional orthopedics has become an evidence based approach to sports medicine related injuries and as an alternative to a major surgical reconstruction or replacement for an arthritic or chronically injured bone or joint. I am a member of the Regenexx network and, have continued to compile and contribute scientific evidence to support the Regenexx mission. Our menu of surgical alternatives is directed to afflictions of the musculoskeletal system.

A patient attempting to postpone or avoid a major orthopedic procedure for an arthritic joint and return to a relatively symptom free functional quality of life may find legitimate, well intentioned and evidence based regenerative medicine and interventional cellular orthopedic initiatives. I am proud to be one of those clinical settings

Next week, I will complete my interview with Dr Mitchell Sheinkop, part two-focusing on common athletic injuries amenable to cellular orthopedics and joint condition amenable to stem cell intervention.

To schedule an appointment call (312)475-1893
To visit my web site go to www.sheinkopmd.com
To watch my webinar visit www.ilcellulartherapy.com

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An exclusive Interview With Interventional Orthopedic Surgeon, Mitchell Sheinkop, MD

Mitchell B. Sheinkop, M.D. — Mon, 20 Feb 2017 21:15:55 +0000

Blog: “Please explain Interventional Orthopedics?”

Dr Sheinkop: “Five years ago, after 37 years of performing hip and knee replacements at a major medical center in Chicago, where I served as director of the Joint Replacement program, I exchanged the scalpel for a needle. Having achieved my surgical goals, I elected to help pioneer the emerging subspecialty of interventional orthopedics, introducing clinical research so that regenerative medicine in the musculoskeletal system would be evidence based. Instead of a long incision, lengthy rehabilitation, potential major complications, and potential infection, I use bone marrow and growth factor concentrate through a needle to help a patient reduce or eliminate pain from an arthritic joint, improve motion and increase functional capacity.”

Blog: “Why did you take this route?”

Dr Sheinkop: “My clinical joint replacement research initiatives, wherein every patient on whom I had operated was closely monitored and followed, made me realize that patients under 60 were too prone to early revision surgery; that is a repeat replacement in a relatively short time. I became aware of the potential of the stem cells and growth factors in bone marrow concentrate to assist a patient with grades two and three arthritis of a major joint in postponing, perhaps avoiding a major joint replacement. As well, for older patients with grade four osteoarthritis who have too many co-morbidities and aren’t safe surgical risks, Bone Marrow Concentrate is a reasonable option.

Blog: “What evidence have you accumulated?”

Dr Sheinkop: “80% of our patients are very satisfied after four years. At the knee, only 7 % have gone on to have a joint replacement. At the hip, that number is about the same. I now have about four percent of patients who have undergone or are scheduled to undergo a repeat Bone Marrow Concentrate procedure after three to four years. Equally important is the comparison of activities after a Bone Marrow/ Growth Factor intervention versus a Total Joint Replacement. I have arthritic knees, grade three. I underwent an intervention on my left side 18 months ago. Last weekend, I went fly fishing for two days in Southwest Wisconsin walking along the creeks, at times in the spring creeks. This week, I am going skiing in Vail with my family. None of this would be possible with a joint replacement.”

Blog: “This is fascinating information; so much so that I want to continue this interview into next week. I want to ask you in particular about the acetabular labrum which seems to be receiving all kinds or attention, arthroscopic knee meniscectomy in the presence of arthritis, non-surgical alternatives for a torn ACL, and subchondroplasty”

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On the results of injecting Bone Marrow Concentrate into the joint and into the adjacent bone for osteoarthritis

Mitchell B. Sheinkop, M.D. — Sat, 04 Feb 2017 20:01:22 +0000

Options for treating patients with osteoarthritis of their joints are historically limited to pain medication, anti-inflammatory medications, steroids, physical therapy, chiropractic care, or any combination thereof. These treatments provide temporary symptom relieving care, but do not offer therapeutic benefit in altering the degenerative disease progression. While pain medication, steroids and anti-inflammatories may help temporarily with pain management, they do not have a long-lasting impact on healing of articular cartilage in the arthritic joint. Without a regenerative therapy, the osteoarthritis will continue to progress, and ultimately will result in a total joint replacement as the only option to manage pain. While the majority of joint replacements have proven successful, there is an inherent complication risk; sufficiently significant enough that a patient prior to surgery might want to look for a means of postponing, perhaps avoiding a joint replacement. A treatment that might slow or even reverse the degenerative process. Four and a half years into my Cellular Orthopedic initiative, I believe the evidence I have compiled supports the use of the patient’s own concentrated bone marrow derived cells (BMC) in combination with the patient’s own concentrated Platelets and Plasma as an alternative to a major joint replacement.

Accomplished in a surgi-center under local anesthesia, an intra-articular injection, with image confirmation of needle and orthobiologic placement, is performed with Concentrated Bone Marrow mixed with concentrated Platelets and Plasma. Recently, based on publications in the scientific literature, I have added a subchondroplasty, that is an injection of some Bone Marrow Concentrate and Platelet Rich Plasma Concentrate into the bone adjacent to the joint. After six months of having introduced the subchondroplasty when indicated to the intra-articular injection, the presumptive evidence encourages me to continue the combined procedure. I started with the knee and I have extended subchondroplasty to the hip and shoulder.

When I began the combined procedure, that is injecting Bone Marrow Concentrate into the joint as well as into the bone adjacent to the joint, I limited the indication to patients under age 60. In August of 2016, a clinical paper was published reviewing the results of said interventions into patients older than 60; Total Knee Arthroplasty versus cell therapy in bilateral knee osteoarthritis in patients older than 85 years. Space doesn’t allow me to reproduce the entire article but in those patients who had a TKR on one side and a combined intervention into the knee and into the bone supporting the knee with Bone Marrow Concentrate, the majority of patients expressed a preference for the stem cell therapy.

To learn more or schedule an appointment, call (312)475-1893

You may visit my blog posted on my website www.sheinkopmd.com

You may view my webinar at www.ilcellulartherapy.com

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Some Stem Cell Background Observations

Mitchell B. Sheinkop, M.D. — Fri, 27 Jan 2017 21:24:18 +0000

There are approximately 2,500 Adult Mesenchymal Stem Cells per mL of Bone Marrow Concentrate on average according to the work of Dr. Phillipe Hernigou in Paris. It leads me to conclude that unconcentrated bone marrow aspirate doesn’t have enough MSCs per unit volume to contribute to a therapeutic potential in a consistent manner. The way MSC counts are done is by assaying Colony Forming Unit-Fibroblasts (CFU-F) from samples taken from the BMC at the time of an arthritic intervention. This is a retrospective look as the CFU-F assay is done by culturing for seven to ten days with a sample of the injectate at the time the intervention with concentrated bone marrow is completed.

Is this too much information? Many patients ask me relevant questions so I thought I would try to clarify. Why don’t I just inject bone marrow concentrate into a vein? Mice were injected in a laboratory using both a vein or an artery and the cells were tracked over time. When using a vein, a significant entrapment of cells was found in the lungs. When using an artery, the entrapment of cells was at a site of injury or disease but not in a joint. Finally, delivering cells directly to the arthritic joint kick starts the repair process offering the best possible outcome.

Why don’t I use or even recommend cultured cells? If cultured cells are used, this procedure goes beyond the realm of minimal manipulation and proves contrary to FDA guidelines. In addition, culturing cells can potentially alter the properties of the cells. It is also important to remember that Mesenchymal Stem Cells have better homing capabilities, compared to their culture-expanded counterparts.

Why is Bone Marrow Concentrate so much more effective than Platelet Rich Plasma? Recent publications have documented that interleukin 1 receptor antagonist protein (IL1-ra), an anti-inflammatory protein is over 22 times higher in BMC than PRP. Additionally, the immune capacity of bone marrow is such that infection is rare when Bone Marrow Concentrate is used.

We are dedicated to providing patients the best possible care in regenerative medicine. The laboratory I use is registered with the FDA. The process I employ has cleared two FDA audits with no issues. Based on the platform I employ, we offer our patients customized interventions, since each preparation is analyzed for platelets, red blood cells and white blood cells (among 27 parameters) which I review prior to injection. The knowledge allows me to make adjustments based on almost five years of experience in Interventional Orthopedics and 37 years as a joint replacement surgeon. No other Regenerative Medical program or practice may make this claim.

To learn more call (312) 475-1893 to schedule a consultation

View my web site at www.sheinkopmd.com

Watch my webinar at www.ilcellulartherapy.com

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When is a Bone Marrow Concentrate Intervention a Failure?

Mitchell B. Sheinkop, M.D. — Fri, 20 Jan 2017 01:48:48 +0000

Last week, a patient who had enrolled in the initial Regenexx Stem Cell Clinical Trial for an arthritic knee visited the office for his five year follow up. He had never paid a nickel out of pocket other than obligatory office co-pays for the intervention. Five years after the administration of concentrated bone marrow, he shared his dissatisfaction with the five-year outcome indicating he had scheduled a total knee replacement because of the ” failure”. The same week, four years after another patient had undergone a bone marrow concentrate intervention for his arthritic hip on a fee for service basis, the patient thanked me for having assisted his return to an active lifestyle. With the return of some symptoms, he asked that I repeat the procedure and help him delay a total hip replacement for another four years, perhaps longer.

What is the benchmark of success when it comes to a cellular orthopedic intervention? On the one hand, five-year postponement and electing to undergo a joint replacement or four years of enabling an active lifestyle and then repeating the intervention. From the humanistic side, the unhappy patient always had a demand and a complaint when seen over the five years while the positive patient always had a smile and a thank you.

Over the several years since beginning my Interventional Orthopedic Practice, I have significantly improved the techniques and technology. In addition, over the last month, I have added the technology enabling customization of the injectate with the addition of the Hemoanalyzer to our algorithm. As in any outcomes analysis, there is the subjective component and the objective component. The ultimate determinant as I see it is the activity profile and scoring.

My Interventional Orthopedic practice is focused on protecting my patients from unproven treatments that may be harmful and unethical, financially exploiting the public; First No Harm. Witness the seductive newspaper ads placed by non-MDs offering stem cells for regeneration using amniotic fluid. I am compliant with federal regulations and the Principal Investigator in a national Amniotic Fluid Clinical Trial. From a scientific perspective, while amniotic fluid may be beneficial for six to 18 months, the proper dosage has yet to be determined and there are insignificant living stem cells in that which is being offered. Also, note that tissue-based stem cell products may not be administered in the absence of an FDA approved indications or approved research protocol.

My Regenerative Medicine, Interventional Orthopedic practice is evidence based and everything that I do is under IRB protocols; that is FDA oversite.

To learn more, you may schedule a consultation by calling 312 475 1896

View my website www.sheinkopmd.com

View my webinar at www.ilcellulartherapy.com

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Regenerative Medicine over exposure

Mitchell B. Sheinkop, M.D. — Sat, 14 Jan 2017 23:00:41 +0000

The Blog this week was inspired by the phone call from a patient cancelling his scheduled Bone Marrow Concentrate/Stem cell procedure because he had heard about a superior alternative; namely, a white cell concentrate injection for arthritis. My initial response, “no such thing”. Then I gave it further thought and I realize patients are becoming victims of over exposure to purported stem cell options via newspaper ads, radio commercials, e-mail marketing campaigns and web sites all providing, for the most part, unscientific and false information to recruit a patient with a profit oriented motive. Making matters worse is the phenomenon of the modern web site designer; all you need is to hire one and you can become a major influence in the Regenerative Medicine environment.

Patient protection in the new world of Regenerative Medicine and Cellular Orthopedics will only be realized when a patient chooses the physician and let the expert educate, provide informed-consent, and make the appropriate recommendation based on Outcomes Science and Evidence Based Medicine. Expertise is not found because of the best marketing web site or a media campaign. There is really too much Regenerative Medicine worthless information available.

An arthritic patient indeed should make an effort to become informed prior to a procedure; but work with the expert to understand your options and the best alternative for you. All my recommendations are based on my 37-year joint replacement experience wherein I pioneered the integration of surgical care with scientific clinical trials and outcomes surveillance. For the past four and a half years, I have duplicated the initiatives in an orthobiologic based clinical practice gathering scientifically accepted Outcomes Measurements on the patients I treat. As a result, three separate corporations in the Orthobiologic world have asked me to function a Principal Investigator on new approaches to help a patient with an arthritic joint postpone, perhaps avoid a joint replacement.

If you have a symptomatic, arthritic joint, call and schedule a consultation. After taking your medical history, completing an orthopedic physical examination and reviewing images of the problematic joint, I will explain the several Cellular Orthopedic options and work with you at determining which alternative best meets your needs.

Call 312 475 1893 to schedule the consultation or you may access my website www.sheinkopmd.com.

The other educational option is to view my webinar www.ilcellulartherapy.com

Don’t let yourself fall victim to the plethora of unscientific claims and misinformation found online

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Cellular Orthopedics versus The Regenerative Medicine Charlatans

Mitchell B. Sheinkop, M.D. — Fri, 06 Jan 2017 05:07:43 +0000

In reviewing the plethora of proliferating Regenerative Medicine web sites, I found one with multiple points of service in metropolitan Chicago offering platelet rich plasma, fat graft, adipose derived stem cells and bone marrow derived stem cells in an office setting for the treatment of ALS, Alzheimer’s, Erectile Dysfunction, Alopecia, Autism, Cerebral Palsy, Aesthetic improvement and so on and more. There was no end to the promises advanced. At no time was there any evidence of success posted and absolutely no data.

For the first 37 years of my orthopedic practice, I collected outcomes data for every patient in whom I performed a hip or knee replacement. Prior to a surgical procedure, I provided the patient with meaningful outcomes data concerning success and length before a revision surgery might be required. That scientific documentation was scientifically published and used globally for informed consent by orthopedic surgeons around the world. Anticipating the future, actually the present if you live in Alabama, not only do I quantitate that which is injected into an arthritic joint, I am able to qualitate the injectate. I refer to Alabama because that State requires a physician to know exactly what is being injected into a patient when a she or he administers such or the physician is not complaint with that state’s law. With the incorporation of Abbott’s Ruby hemoanalyzer into my Cellular Orthopedic practice, I meet ethical, moral, legal and scientific guidelines and anticipate what I believe will shortly become an FDA compliance requirement. My practice is limited to that which has data to support my recommendations for a symptomatic, arthritic joint; while at the same time documenting the quality and quantity of the combination of Bone Marrow Concentrate, Growth Factors and Platelet Rich Plasma I am injecting.

There is the beginning of an initiative to comply with an anticipated more stringent oversite by the FDA concerning the developing subspecialty of Interventional Orthopedics and I am thrilled to be part of that small group. The FDA is a governmental agency responsible for the well-being, health and safety of the public. While likesome charlatans might get by in the short term, I am thrilled to be part of this initial group of responsible Board Certified Orthopedic Surgeons, Physiatrists and Pain Management specialists providing scientifically supported, FDA compliant, Cellular Orthopedic and Regenerative Medicine options in Sports Medicine and for management of an arthritic joint.

You may schedule an appointment by calling 312 475 1893

My Website is reached at www.Sheinkopmd.com

You may watch my webinar at www.ilcellulartherapy.com

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