Posts Tagged Clinical Trial. Mitchell B. Sheinkop

Overcoming Orthopedic Opposition to Stem Cells

      

Orthopedic Care of the Mature Athlete

Will stem cells work in relieving the pain from an arthritic joint; that is the question? A patient read my blog and called to discuss his experience with the orthopedic surgical community. Since his is not the first time I came across opposition to Regenerative Medicine, I thought I would focus on that resistance this week.

An orthopedic surgeon is just that, a surgeon. Usually trained with a major emphasis on surgical technique and evidenced based medicine, it is difficult to foster change within the orthopedic community. I should know as I practiced orthopedic surgery for 38 years developing that surgical technique in the joint replacement sub specialty and doing the clinical research that led to the evidence forming the basis of modern hip and knee replacement surgery. During that era, I also noted the failures of joint replacement and other adverse outcomes so I started seeking an alternative to joint replacement, basically a biological arthroplasty.You better believe the orthopedic community has not rapidly adopted this latter concept in theory. Yet, orthopedic surgeons have been attempting cartilage restoration for over seven years and actually informing the surgical candidate about stem cell treatment of arthritis every time they performed an arthroscopic micro fracture. The Arthroscopic Package for the injured or arthritic joint includes micro fracture. The explanation behind the technique of micro fracture is that one is allowing a patent’s own adult mesenchymal stem cells to migrate from within the bone marrow to the joint by creating multiple small holes in the diseased cartilage communicating with the marrow. The only problem with the hypothesis, no matter how enticing, is that by time a patient reaches the age of 40 to 50, there is no active marrow remaining near the knee and very little remaining at the hip or the shoulder. Why not then, harvest bone marrow from the pelvis where it is plentiful at any age,  filter out the stem cells and concentrate them followed by reinjection after the micro fracture? It makes all the sense in the world, is worthy of clinical trial and outcomes surveillance, and does not make the Arthroscopic Package much more complex.

In my attempt to overcome the negative reaction of the orthopedic clinical community to my Regenerative Medicine initiative increasingly made known to my patients, I sought the guidance of the leader of a think tank and a mentor, Chef.

Dr Sheinkop: “How do I overcome resistance to my procedure of the future when the orthopedic surgeon has been using it for over five years?”

Chef: ” Forget all that genetic engineer whoosa-fudge…….if you want to combine a pig and an elephant, just get them to make sweet love”

 Dr Sheinkop: “The orthopedic surgical community will never accept a non operative approach to the management of arthritis if it threatens a decrease in the number of procedures.”

 Chef: “Sure they would but you’re gonna have to get’em in the mood”

 In August, I have been invited to speak before an orthopedic audience for the first time to share my earliest observations regarding response to stem cell management of arthritis. Two weeks ago, I did my first case; last Wednesday, I did three. It won’t be a series on which to report but I certainly will have something new to share. The Reality show to be continued.

 

 

 

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Arthroscopic Treatment of Osteoarthritis doesn’t work

 

 

Might minimally invasive stem-cell treatment for conditions causing knee or hip pain secondary to common injuries or other degenerative problems be a substitute treatment for arthroscopy or even total joint replacement? If you are experiencing joint impairment and the MRI is “positive”, the pain is most probably due to the bio-immune and inflammatory changes of degenerative joint disease and “wear and tear” arthritis rather than a torn meniscus or acetabular labrum. You may want to investigate Bone Marrow Concentrate derived stem cell management rather than undergoing a surgical procedure of the hip or knee.

Traditional options for patients suffering from joint pain and altered life style include arthroscopic surgery or total joint replacement. With both surgeries, months of rehab are required, the outcome is not guaranteed and the patient must be aware of and prepared to take on the risks.

 Original Article

Incidental Meniscal Findings on Knee MRI in Middle-Aged and Elderly Persons

Martin Englund, M.D., Ph.D., Ali Guermazi, M.D., Daniel Gale, M.D., David J. Hunter, M.B.,B.S., Ph.D., Piran Aliabadi, M.D., Margaret Clancy, M.P.H., and David T. Felson, M.D., M.P.H.

N Engl J Med 2008; 359:1108-1115September 11, 2008

Magnetic resonance imaging (MRI) of the knee is often performed in patients who have knee symptoms of unclear cause. When meniscal tears are found, it is commonly assumed that the symptoms are attributable to them.  The prevalence of a meniscal tear or of meniscal destruction in the painful knee as detected on MRI ranged from 19% (95% confidence interval [CI], 15 to 24) among women 50 to 59 years of age to 56% (95% CI, 46 to 66) among men 70 to 90 years of age. Among persons with radiographic evidence of osteoarthritis (Kellgren–Lawrence grade 2 or higher, on a scale of 0 to 4, with higher numbers indicating more definite signs of osteoarthritis), the prevalence of a meniscal tear was 63% among those with knee pain, aching, or stiffness on most days and 60% among those without these symptoms. The corresponding prevalence among persons without radiographic evidence of osteoarthritis was 32% and 23%. Sixty-one percent of the subjects who had meniscal tears in their knees had not had any pain, aching, or stiffness during the previous month.

Conclusions

Incidental meniscal findings on MRI of the knee are common in the general population and increase with increasing age.

What about the hip? Leah Ochoa published an article in CORR, 2010 that 87% of patients with hip pain have at least one finding of Femoral Acetabular Impingement on X-ray with a high rate of labral tears found on asymptomatic volunteers. The message, if you have less than 2mm of joint space on an X-ray, the problem does not lend itself to hip arthroscopy. If you have any reduced motion of your hip and a “positive” MRI for a labral tear, don’t treat the MRI, look further. Might stem cell management help avoid or postpone surgery? Call to learn more

 Mitchell B. Sheinkop, M.D.

1565 N. LaSalle Street . Chicago . Illinois . 60610

312-475-1893

 

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The Botox for your frame, Stem Cells

Musculoskeletal Care of the Mature Patient

The number one reason in the United States for a trip to a physician has to do with pain arising in the musculoskeletal system, especially in the Boomers and maturing athletes. Might regenerative medicine and stem cells provide an extended warranty for your frame? That was my basic question when I attended the American Academy of Orthopedic Surgeons continued medical education course last weekend “Advances in Care of the Aging Athlete”. What was generally reinforced is that the number one way to stay healthy and young is through fitness and sports; stay active on an aging frame. In other words put old on hold. Certainly proper nutrition is a key component as is Resveratrol and maybe testosterone supplementation for Manopause. Woman beware, hormone replacement therapy is generally not good for your health.

In the end though, the real problem is cartilage deterioration with age be it from genetics, congenital, developmental insult or trauma. The recent media attention to stem cells has introduced a clinical possibility of changing the natural history of progression of degenerative arthritis and perhaps even reversing the programmed death of cells. Peyton Manning went to Europe for stem cells in the neck, Governor Perry chose Asia for his back and Terrell Owens returned to football after stem cell intervention in Korea. You all probably are aware of the Fred Couples, Kobe Bryant and Alex Rodriguez having returned to top performance with the assistance of regenerative medicine. By harvesting Mesenchymal Stem cells form you bone marrow and concentrating them, the injectate is the best of all potential immune modulators with the greatest possible ant-inflammatory effect. There are a large number of animal studies confirming the efficacy of stem cell management of cartilage; such clinical treatment is now the standard of care in the veterinarian world, particularly with the injured or arthritic hoarse. As well, there is an emerging body of science to support adult mesenchymal derived stem cell management of the aging human joint appearing in peer reviewed medical journals. The International Journal of Rheumatic Diseases to illustrate, recently published an article concerning four patients with moderate to severe osteoarthritis of the knee who experienced marked improvement with mesenchymal stem cell therapy. The problem is that for the most part, human clinical trials are taking place outside the United States. Enter Regenexx and its IRB clinical trial. That’s why I joined the Regenexx Network. To learn more, schedule an appointment.

 

 

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Stem cells are how we all begin

The Regenerative Pain Center is about to begin as well.  I completed my training at Regenexx on Thursday and started enrolling patients on Friday. I chose to affiliate with Regenexx because theirs is the longest and largest outcomes database pertaining to the clinical use of stem cells in the care and treatment of arthritis and musculoskeletal injury. Certainly, there remains a major role for orthopedic surgery in the management of arthritis and joint injury but now the patient has an option. Given the fact that 15 to 20% of joint replacement recipients have complication or unsatisfactory outcomes or are never able to resume the type of activity previously enjoyed, it makes all the sense in the world to exhaust the regenerative care option before a joint replacement.  While I was writing this Blog, my landlord dropped by to tell me the saga of his son-in-law’s father. The latter, a surgeon himself, still is experiencing pain and repeated hemorrhage into his knee eight months after a knee replacement. The ongoing problem is contributing, in part, to his decision to retire. Might he have avoided a knee replacement if he had tried the regenerative medicine route?

The world of stem cell management is a commitment for me because I believe in the process. It is also dynamic, as another means of approach has been introduced for stem cell harvesting that is very promising and less complicated than bone marrow harvesting. Blood born stem cells may now be captured by concentrating platelet rich plasma. Until now, PRP, while having some stem cell component, was really an anti-inflammatory approach because of a wealth of growth factors. With the recent introduction of a major advance in platelet concentration methodology by Regenexx, ultra concentrated PRP, introduces a potential sufficient quantity of stem cells to begin to mirror the possibilities of bone marrow derived stem cells.

To complete my preparation and credentialing for the transition from a reconstructive joint replacement surgeon to a regenerative medicine restoration physician, I am off to the American Academy of Orthopedic Surgeons course “Advances in Care of the Aging Athlete” on Thursday. In addition to stem cells, the subject matter includes Nutrition and Supplementation: Optimization with Aging; Anti-Aging and Performance Drugs; Cartilage Restoration; Knee Rehabilitation in the Arthritic Knee: How Much Can We Push?; The Basic Science of Aging: Implications for the Male and Female Master Athlete; Injectable Adjunctive Therapies: Solid Treatment or Snake Oil: Performance Optimization in the Masters’ Athlete; and more. I won’t live forever; but while I am still here, my ethos is “Just Do It”. To learn more, call and schedule an appointment.

Mitchell B. Sheinkop, M.D.

847-390-7666 or 312-475-1893

1565 N. LaSalle St., Chicago, Illinois 60610

 

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On Restoration, Regeneration and Resurrection

 

Musculoskeletal Care of the Mature Patient

I feel the pain. This weekend was spent with my wife chasing trout in the Driftless Area of southwestern Wisconsin and I am hurting.  Walking down a creek for miles is an adventure that is unlike no other. I have no idea what this has to do with stem cells so let’s get back to the week to be, actually the month ahead.

Passover begins in the evening of Friday, April 6 and ends in the evening of Saturday, April 14

Easter is Sunday, April 8

Regenexx visit is Monday, April 9 to Wednesday, April 11

Biovision needlescope introductory to regenerative medicine, April 12

American Academy of Orthopedic Surgery course “Advances in Care of the Aging Athelete” April 20 to April 22

I am undertaking an entire new direction as an orthopedic surgeon who performed and pioneered joint replacements for over 38 years. All I had to do was read the newspaper and listen to the media reports on orthopedic implant recalls to remind myself that someone from the orthopedic surgical community has to look ahead to alternative options for pain solutions. The AAOS course will address issues from stem cell and adjunctive therapies, nutrition, performance enhancing drugs, cutting edge regenerative and restorative treatments, and the application of other anti-aging substances and supplements for the shoulder, hip and knee-all with the goal of keeping patients well and at the top of their game. If you are severely impaired, then you still may need a joint replacement; but if you are still functional, there are viable alternatives to surgery.  For the female athlete, I am developing an expanded approach to treatment and maintaining the opportunity to participate. My focus is personal and is somewhat brought about by my own interests, anti-aging and managing the aging process. Normal physiologic effects of aging affect participation in sports; reader, you are left to define the word sports. There is not necessarily a predictable positive impact of a joint replacement on function even if the implant is not recalled. If you want to analyze how cartilage regenerative techniques may apply to you in the new world of regenerative stem cell based medicine, call for an appointment. I will work with you to determine appropriate non-operative and minimally invasive stem cell treatment plans for mature adult “athletes” with traumatic, degenerative and arthritic conditions particularly related to the knee, hip and shoulder.

Mitchell B. Sheinkop, M.D.

847-390-7666 or 312-475-1893

1564 N. La Salle St

Chicago, Illinois 60610

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This Week’s Top Stories

 

British Hip Society recommends against use of stemmed, large diameter, metal-on-metal implants in primary total hip replacements.

Based on discussions held at its annual meeting, the British Hip Society (BHS) has issued a statement on the use of large diameter metal-on-metal bearing total hip replacements. BHS advises that stemmed, large diameter metal-on-metal primary total hip replacements using bearings of 36 mm or greater should no longer be performed until more evidence is available, except in properly conducted and ethically approved research studies. The advice does not apply to hip resurfacing. In addition, BHS endorsed guidance recently issued by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), calling for annual monitoring for the life of the implant, as a precautionary measure.

Other News 

FDA committee to discuss reports of joint destruction associated with anti-NGF drugs.

The U.S. Food and Drug Administration (FDA) plans to hold a meeting next week to discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development, along with safety issues possibly related to the drugs. Anti-NGF drugs are being developed for the treatment of chronic painful conditions such as osteoarthritis, chronic lower back pain, cancer pain, and other conditions. An advisory committee will be asked to determine whether reports of joint destruction represent a safety signal related to the anti-NGF class of drugs, and whether the risk-benefit balance for these drugs favors their continued development as analgesics.

Sheinkop meets with Regenexx in Colorado to evaluate new office based needle arthroscopic system

While it is true that I was skiing last week in Vail, while I vacationed, I still worked on assuming a leadership position in the new world of regenerative medicine. What I as an individual am able to contribute is my background and experience in research and clinical practice of treating arthritis with joint replacement surgery. Now I am dedicating myself as an orthopedic surgeon to avoiding or postponing joint replacement. When arthritis is debilitating and the X-ray is that of bone on bone, there is still an indication for a new hip or a new knee. But patient beware, there are restrictions inherent in a new joint. My life-long biking, skiing and fly fishing buddy, has relatively severe arthritis of his left knee. Yet he still can bike faster and ski better than me-I out fish him-because he has taken my counsel and postponed, maybe avoid a knee replacement via Regenerative Medicine.

To learn if you are a candidate for regenerative medicine, feel free to call

Mitchell B. Sheinkop, M.D.

847-390-7666 or 312-475-1893

1565 N. LaSalle St, Chicago, IL 60610

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Saving umbilical cord blood

                                               

In the beginning, there was an umbilical cord. The blood in that cord was and is an invaluable source of stem cells that is unique to your body and family. These cells may be used to treat nearly 80 serious medical conditions at last count including leukemia, other cancers, and blood disorders. Cord blood stem cells are showing significant potential to treat conditions that have no cure today as juvenile diabetes and brain injury. Saving your baby’s or your grandchild’s cord blood secures the best treatment option for a healthy future.

According to the U.S. Department of Health and Human Services, “This revolutionary technology (regenerative medicine) has the potential to develop therapies for previously untreatable conditions. Examples of diseases regenerative medicine can cure include diabetes, heart disease, renal failure, osteoporosis, and spinal cord injuries. I am now ready to announce my personal entry into the new world of regenerative medicine in conjunction with the Regenerative pain Center by having joined the Regenexx network of physicians. I will start screening patients for bone marrow concentrate pilot study as of March 25th. The actual clinical process will be introduced at the beginning of May at the Regenerative Pain Center. There is as yet no assurance that bone marrow concentrate rich with autologous mesenchymal adult stem cells administered in to an arthritic joint will reverse arthritis or even stop progression but with the anecdotal observations around the country, I believe that as an orthopedic surgeon, I might or could be able to delay or avoid a joint replacement. Our pilot study will be the first step. In order to qualify, a patient will need to meet certain criteria determined by history, physical examination, X-ray and MRI. At times, a diagnostic out patient arthroscopic examination or prior treatment may be part of the program. For those who don’t qualify for the study, the patient may still seek treatment with a self-pay alternative.

Transplant medicine uses stem cells to help treat serious diseases, such as cancers and blood disorders. Regenerative medicine is a new and rapidly advancing area of medicine focusing on developing treatments using stem cells to repair damaged tissues and organs. The estimates to date that someone in your family will use stem cells in a lifetime include:

Transplant Medicine: 1 in 217

Regenerative Medicine: 1 in 3

I am thrilled to announce my entry in to the emerging stem cell application regenerative process. To learn more or see if you qualify, call the number listed below.

Mitchell B. Sheinkop, M.D.

847-390-7666

1565 N. LaSalle St., Chicago, Illinois, 60610

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Bone Marrow Concentrate for Arthritis; the potential benefits and risks

      

Musculoskeletal Care of the Mature Patient

The potential benefit of regenerative medicine is avoidance of orthopedic surgery. That’s the goal and I am the orthopedic surgeon leading the charge. I have spent several years now investigating, meeting, traveling, learning and preparing for that reality with the start-up anticipated in mid-April. While there is anecdote about subjective improvement following autologous, mesenchymal, Bone Marrow Concentrate derived stem cells for management of arthritis, there are no peer reviewed published long-term clinical outcomes to the best of my knowledge. There have been testimonials by orthopedic surgeons that following the adjunctive use of stem cells in conjunction with arthroscopic micro fracture of an arthritis knee, when the patient subsequently underwent knee replacement, hyaline cartilage was observed growing rather than fibro cartilage. This is not good enough for me, as I want a procedure that will postpone the need for a joint replacement or possibly eliminate that need. Is it a matter of when to intervene with regenerative medicine? When there is major deformity of an arthritic joint, significant alteration in function and a “bone on bone” X-ray, it probably is too late. Will regenerative medical intervention delay the joint replacement by a three to five year control of pain by the anti-inflammatory nature of bone marrow concentrate or will the joint cartilage actually re-grow? These are unanswered questions and what I seek to learn as I embark on my clinical project

Recently, the orthopedic surgical spine community became aware of a fourfold risk of cancer in patients who underwent spinal fusion using Bone Morphogenic Protein to increase the likelihood of successful fusion. As a result, attention quickly was redirected to stem cells as an adjunct in spinal surgery to replace human BMP. As of this writing, I have found no evidence of carcinogenesis in conjunction with autologous, mesenchymal Bone Marrow Aspirate Concentrated stem cells used in the skeleton and certainly not when used in a joint. The same might not be said when embryonic stem cells have been injected into the blood of patients to treat probably what shouldn’t be addressed with stem cells in the first place. Desperate people are not infrequently victims of charlatans as has been repeatedly pointed out on 60 Minutes. Contrast the risks of stem cell misdeeds with the benefits of scientific application. Today, the AMA News headline covered the potential for stem cells to eliminate the need for long-term anti-rejection pharmaceuticals in organ transplant recipients.

How to avoid orthopedic surgery by an orthopedic surgeon? Not just a mission statement by an ethos. Call to see if you are a candidate.

Mitchell B. Sheinkop, M.D.

847-390-7666

1565 N. LaSalle Street, Chicago, Illinois 60610

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Surfing the Internet for stem cell updates

The New York Times (2/27, A8, Wade, Subscription Publication) reports, “Researchers at Massachusetts General Hospital say they have extracted stem cells from human ovaries and made them generate egg cells.” The report, “if confirmed, might provide a new source of eggs for treating infertility, though scientists say it is far too early to tell if the work holds such promise.”

The AP (2/27) reports that lead researcher Jonathan Tilly of Massachusetts General Hospital “collaborated with scientists at Japan’s Saitama Medical University, who were freezing ovaries donated for research.”

        Bloomberg News (2/27, Flinn) reports “stem cells from the ovaries were injected into human ovarian tissue that was then grafted under the skin of mice, which provided the blood supply that enabled growth.” In less than “two weeks, early stage human follicles with oocytes had formed.”

        The Boston Globe (2/27, Johnson) reports, however, that “scientists not involved with the Mass. General research said such an approach – if it is even possible – sits far in the future and will require considerably more work.” A number of “scientists said Tilly, who cofounded a company focused on developing novel infertility treatments, had not yet made a convincing case that the stem cells he discovered can yield viable eggs, a critical first step.”

        The Wall Street Journal (2/27, Naik, Subscription Publication) reports that the research, published in published in Nature Medicine, was funded by the National Institutes of Health, among others.

        HealthDay (2/27, Goodwin) reports that although “it was long believed that women were born with a lifetime supply of eggs, which was depleted by menopause,” an increasing “body of research,” such as this study, “suggests egg production may continue into adulthood.” Also covering the story are MedPage Today (2/27, Bankhead) and WebMD (2/27, Goodman).

        Regenexx Web Site KJ is in his late 70′s and was evaluated by us in 2008, after a lifetime of knee problems since a torn meniscus in the 1960′s. After multiple failed arthroscopic knee surgeries through the 2000′s, he was told he needed a knee replacement. His MRI showed complete loss of the meniscus in the left knee (which had been surgically removed in the 1960′s) and severe cartilage loss (bone on bone), so he was told that he was a fair-poor candidate for the procedure (his knee is featured in this prior blog post). He didn’t want a knee replacement, so he decided to give the procedure a try. We treated him with the Regenexx-C knee stem cell treatment as well as a barbotage procedure to remove bone spurs and some injections to tighten his very loose ACL knee ligamentHis last update on how the knee did with stem cell treatment is here. I examined him today, more than 2.5 years after his knee stem cell injection and his knee still feels great. He walks several miles a day, climbs ladders and stairs, and works on home improvement projects, all without significant pain other than mild stiffness now and then. His exam showed no significant tenderness or swelling. Looks like KJ was able to dodge the knee replacement bullet long-term because of an injection of his own stem cells and an Interventional Orthopedics approach

I am off to Regenexx on Friday.

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Hand Surgery Alternative for Arthritis and Injury

I have recently seen an increasing number of patients with altered function of their hands because of pain or reduced range of motion due to common injuries, overuse, basal joint arthritis/osteoarthritis, or other degenerative problems.

Thumb arthritis (or basal joint arthritis) can appear early in life.  Because of the constant swiveling and pivoting motions of the basal joint–the joint at the base of the thumb, or thumb CMC (carpometacarpal) joint–the thumb joint tends to wear out easily. Basal joint arthritis is also common in people who have osteoarthritis. As well, tendinitis in the wrist and hand is rampant because of over use of the computer mouse and improper ergonomics.

One way to treat the arthritic condition is with total joint reconstruction surgery. Perhaps over use syndromes may be reduced via voice recognition software but I personally still need to edit and then correct about 15% of my dictations. While surgery may improve the condition for some, this is not the case for all. New problems in the thumb joint may redevelop over time, causing such symptoms as numbness or tenderness. Then there is amazing increase in the occurrence of trigger finger and De Quervains Disease; both which lend themselves to ultrasound guided injection.

 A reasonably successful approach to all of these wrist and hand problems is to start with an ultrasound guided intraarticular cortisone injection. Should the latter be of short-term relief, then platelet rich plasma may be successful for a longer period. Before considering the surgical alternative, be aware that Regenexx has published the outcome of 6 patients who were just under a year out (11.3 months) from treatment with their own stem cells 83.4% of thumb patients are reporting greater than 50% improvement after a simple injection of their own stem cells, 66.7% of thumb patients are reporting greater than 75% improvement and the average change is 70% improved. No significant complications in this group were reported.

If you have pain in your hand or wrist, start with a change in the ergonomics in your work place. Most office suppliers have the necessary mechanical devices available. The next step is an arthritic glove available in most large drug stores. If unsuccessful, the next step is an ultrasound guided injection of cortisone, platelet rich plasma and then stem cells in that order when all else fails.

Mitchell B. Sheinkop, M.D.

847-390-7666

1565 N. LaSalle Street, Chicago, Illinois 60622

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