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

Musculoskeletal Care of the Mature Patient

Forbes , 02/10/2012  Gergana Koleva

Regenerative Sciences, a medical company that pioneered a procedure to treat orthopedic injuries using patients’ own stem cells, is fighting the Food and Drug Administration tooth and nail over a claim that human cells should be federally regulated as drugs, in a landmark case that has far-reaching implications for the future of regenerative medicine.

At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.

Despite the controversy, a number of clinics from coast to coast have licensed their physicians as recently as last month to provide the cell therapy, called Regenexx. This has led to renewed interest by consumers and would-be patients, and prompted the company to publish a sharply worded blog post on its website condemning the FDA’s reasoning.

The lawsuit is “concerning for every American who considers their body not to be an FDA regulated drug factory,” the blog says.

While the treatment that is the focus of the lawsuit is not used for life-threatening injuries, the company claims this case goes beyond a particular procedure to shed light on a misguided push by the FDA to establish authority over aspects of medicine never allowed it by Congress.

Regenexx works by taking a blood sample and a bone marrow sample from a patient and separating out the stem cells via centrifuge, then re-injecting those cells directly into the injured area, where they assimilate into the bone or cartilage and begin to regenerate it.  Physicians for the company have shown in clinical studies cataloged at the U.S. National Library of Medicine that the therapy produces fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.

You may read the entire article on the Forbes web site. On March 2, I will be visiting Regenexx to explore  my joining their network of physicians using stem cells.

Musculoskeletal Care of the Mature Athlete

As I move closer to actually starting up the Bone Marrow Concentrate Stem Cell Pilot Study, I will continue to educate the perspective patient seeking to enjoy relief from arthritis of the hip and knee without a joint replacement. The delay is based on our having to wait for Institutional Review Board approval of our clinical trial. The fact that a procedure is experimental does not automatically mean that it is part of a research study or clinical trial. A responsible clinical trial can be characterized by a number of key features. There is preclinical data supporting that the treatment being tested is likely to be safe and effective. Before starting, there is oversight by an independent group such as an Institutional Review Board or medical ethics committee that protect patients’ rights, and in many countries the trial is assessed and approved by a national regulatory agency, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA). The study itself is designed to answer specific questions about a new treatment or a new way of using current treatments, often with a control group to which the group of people receiving the new treatment is compared. While historically, the cost of the new treatment and trial monitoring is defrayed by the company developing the treatment or by local or national government funding; to date that has not occurred with stem cell trials in the United States. It takes an average of seven years and $750,000,000 to develop a new pharmaceutical therapy. With the rapidity in evolution of regenerative medicine, so far, no company has been identified that is willing to underwrite the expenses of a stem cell Trial. At the same time, beware of expensive treatments that have not passed successfully through clinical trials.

Responsibly conducted clinical trials are critical to the development of new treatments as they allow us to learn whether these treatments are safe and effective. I believe there is enough clinical experience to support a Pilot Study with Adult, Autogenous, Bone Marrow Derived Stem Cells. First no harm and a then reasonable chance of restoring function. To find out if you would qualify for the Pilot Study, contact Jennifer at 312-475-1893   ext.15

Musculoskeletal Care of the Mature Patient

I’m back from a short Blog sabbatical, refreshed and with much to discuss. During the time away, I spent a week skiing in Colorado with my wife, read a book, The Immortal Life of Henrietta Lacks, a must read for anyone interested in or considering regenerative medical care, and kept up on issues that I believe would be of interest to readers. While I was gone, my staff continued to work and both finalized and submitted the request to The Institutional Review Board that will enable us to begin The Bone marrow Aspirate Concentrate Stem Cell (BMAC) management of osteoarthritis.  I will share with you what I read, watched and observed.

From the American Medical Association Morning Rounds of Tuesday, January 24, Leading the News “Stem cell treatment may help patients with macular degeneration”

On NBC’s The Doctors-Jan 25, a Regenexx stem cell procedure is featured for a patient with a failed microfracture in a woman with an arthritic knee seeking return to an active life style.

The Immortal Life of Henrietta Lacks , written by Rebecca Skloot is the fascinating biography of a woman whose cells were harvested without her knowledge in 1956 at Johns Hopkins; and ultimately became responsible for the world of regenerative medicine today. Along with the factual history of how the first cell cultures of human cells has evolved into the practice of medicine as we know it today, one learns about the evolution of medical ethics, government mandated patient protection and informed consent processes that govern contemporary medicine. You will better understand my approach to regenerative medicine when you finish this book named by more than 60 critics as one of the best books of 2010.

We arrived in Vail on Saturday afternoon, January 21, just as a snowstorm was starting. By time we ventured out on Sunday morning, there was 12 inches of fresh powder at the top of Rivas Ridge. It snowed again two more times during the week with another 14 inches of fresh powder by time we headed down Shangri-La in China Bowl. During the week, a friend came over from Breckenridge with his snow- board. By the end of our Wednesday skiing, I needed regenerative care for my entire body; almost no one was on the slopes besides us.

Over the next two weeks, I am scheduled to do site visits to observe and compare notes with centers involved in BMAC. If you want to move forward with learning whether you might be a candidate for regenerative medical care of your arthritis before scheduling that joint replacement, make an appointment or make a call. While no authority can promise success, there is an accumulating body of global information suggesting autogenous, autologous, adult bone marrow derived mesenchymal cells my be an effective, long term, anti-inflammatory and perhaps alter the natural history of degenerative arthritis.

Mitchell B. Sheinkop

1565 N. LaSalle Street

Chicago, Illinois 60610

847-390-7666

Because of the 60 Minute Television program exposing fraud in the marketing of Stem Cells last Sunday, I feel it necessary to preempt the previously announced blog for this week with a word or more of caution.  Sometimes called the body’s “master cells,” stem cells are the precursor cells that develop into blood, brain, bones and all of your organs. When used as a medical treatment, there is the potential to repair, restore, replace and regenerate cells and thereby treat many medical conditions and diseases including arthritis.

But the Food and Drug Administration (FDA) is concerned that the hope, which patients have for cures not yet available, may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.  Witness the Sunday night episode of 60 Minutes.

FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

Regulation of Stem Cells

FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use.

Stem Cells that come from bone marrow or blood are routinely used in transplant procedures to treat patients with cancer and other disorders of the blood and immune system.

Why my Pilot Study and then Clinical Trial? As part of these studies, I must show how the product will be harvested and prepared so that FDA can make certain appropriate steps are being taken to help assure the product’s safety, purity and potency.

Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products.

Advice for Consumers

• If you are considering stem cell treatment in the U.S.,  ask your physician if the necessary FDA approval has been obtained or if  you will be part of an FDA-regulated clinical study. This also applies if  the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their  original location in the body. Cells in a different environment may  multiply, form tumors, or may leave the site you put them in and migrate  somewhere else.
• If you are considering having stem cell treatment in  another country,  learn all you can about regulations covering the products  in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require  clinical studies designed to demonstrate that the product is safe and  effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little   information about foreign establishments or their stem cell products.  China has recently announced a governmental mandated regulation of a prior  free for all in the stem cell market.
• To reemphasize my approach to realizing the promise of  stem cell management of arthritis; treatment at the Regenerative Pain  Center will only be offered via Pilot Study or Clinical Trial under FDA  governance and IRB regulation. Your cells will be harvested from your own bone marrow, concentrated, and administered to your arthritic joint.

Mitchell B. Sheinkop, M.D.

1565 N. LaSalle Street

Chicago, Illinois 60610

847-390-7666

The difference between platelet-rich plasma therapy, also known as PRP, and the Orthokine treatment that Alex Rodriguez, Kobe Bryant and other athletes have received in recent months in Germany is fairly straight forward. I personally treat athletic injuries and arthritis with PRP; but, do not use the Orthokine procedure because it is not approved in the United States or Canada.

With PRP, I withdraw 20 cc blood, spin it in a special kit and inject plasma that is rich in platelets and lymphocytes into joints, thereby introducing growth factor and hopefully helping the body to heal itself. In the Orthokine procedure, 20 ccs of a patient’s blood are mixed in a tube with ‘factors,’ incubated for a time , the blood is spun down, and the substance is injected much in the same way as PRP.

The theory of Orthokine, which has also been used by Alex Rodriguez, Kobe Bryant and golfers Vijay Singh and Fred Couples, among other athletes, is that Orthokine addresses one of the possible triggers of joint disease; thought to be the protein interleukin. The theory is an attack on one of the culprits behind arthritis. The protein is an important part of the body’s immune system and has the ability to alter the function of other cells. IL-1 can be positive when it allows the body’s ‘repair troops’ to move in quickly to fight infection or other kinds of damage; but it can also trigger inflammatory processes that lead to degeneration and breakdown of cartilage.  These negative effects are primarily responsible for the pain and stiffness of osteoarthritis.

The Germans say that another protein that counteracts the effects of IL-1 is a ‘good protein’ in the body called anti-IL(1) produced by blood cells that protects cartilage by keeping the pro-inflammatory proteins in check. It is the body’s own natural anti-inflammatory and that is what gets mixed in prior to incubation.

In none of these treatments, PRP, stem-cell therapy Yankee pitcher Bartolo Colon had performed in the Dominican Republic. Is there good published research readily available that confirms they are effective, although it could turn out to be so. Individual anecdotes suggest they work. The procedures are not banned by the World Anti-Doping Agency or by Major League Baseball. However, Rodriguez was given the go-ahead by MLB and the Yankees to have it done in Germany. While PRP is available throughout the United States, the Regenerative Pain Clinic Bone Marrow Concentrate Stem Cell Pilot is now open for enrollment. Bone Marrow Concentrate has all the right proteins but does it work? Why am I advocating Bone Marrow Concentrate?

 Call to see if you might qualify for the clinical pilot trial.

Mitchell B. Sheinkop, M.D.

1565 N LaSalle Street

Chicago, Illinois 60622

847-390-7666

If you watched the Los Angeles Lakers play the Chicago Bulls over the Christmas weekend, you would have heard the story repeated many times during the broadcast of how Kobe Bryant had traveled to Germany for a Platelet Rich Plasma treatment for his arthritic knee and how PRP is not available in the United States. My congratulations to Kobe Bryant and his doctors, it looks like the treatment worked although the Bulls did win. He played well and there was no visible sign of the bone-on-bone arthritic knee affecting him. To correct the announcers though, you should be aware that platelet rich plasma injection, not unlike that used in the case of Kobe Bryant, is widely available in the United States and FDA approved. Since April of this year, I have personally treated 28 patients with Platelet Rich Plasma including the knee, hip and shoulder. Improvement in arthritic symptoms and increased function has been observed in about 70% of those patients so far. That’s a reasonable improvement for arthritic impairment but is there something better? Might a non-surgical stem-cell treatment for people suffering from knee pain due to common injuries or other degenerative problems be a substitute treatment for arthroscopy or total knee replacement?

 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

Results

The prevalence of a meniscal tear or of meniscal destruction in the right knee as detected on MRI ranged from 19% among women 50 to 59 years of age to 56% among men 70 to 90 years of age. Among persons with radiographic evidence 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.

Because of the aforementioned scientific study, I have determined the following Inclusion criteria for the Bone Marrow Concentrate Pilot Study

1. Age over 50. For patients with an osteoarthritic defect on MRI

2.  Near normal knee alignment

3.  Symptoms referable to the cartilage defect:

          Swelling

          Pain

          Giving way

          Locking

          Crepitation

4.  Early OA with no evidence of inflammatory arthritis

5. >2mm residual joint space on X-ray

6. Unicompartmental osteoarthritis

    a. ROM >-10 to 110

    b. Mechanical axis <12 degrees varus or valgus

    c. Minimal involvement of patella femoral joint

    d. No >2-3mm laxity in any plane

To find out if you qualify for the study, call and make an appointment. For those who don’t qualify for inclusion in the Pilot Study, you still may be a candidate for Bone Marrow Concentrate treatment of your arthritic joint.

Mitchell B. Sheinkop, M.D.

1565 N. LaSalle Street

Chicago, Illinois 60610

847-390-7666

Between May of 2001 and November of 2009, I was an invited visiting professor teaching joint replacement surgery in 76 cities around the world at hospitals, in operating rooms, and at orthopedic conferences in 37 countries including Japan, China, Singapore, Russia, Turkey, Israel, Jordan, Lebanon, Qatar, The United Arab Emirates, Saudi Arabia, Bahrain, North Africa, and the emerging newly independent countries of Central and Eastern Europe. My introduction of American joint replacement methodology extended through most of Asia, Central and Eastern Europe, North Africa and the Middle East. During that span, I hosted in Chicago, several hundred visiting orthopedic surgeons from around the globe to teach them my joint replacement techniques as well introduce basic arthroplasty technique, minimally invasive surgery and new prosthetic made in America designs. I still maintain active scientific exchange serving on the editorial board of orthopedic journals both in Serbia and Poland. All these initiatives have provided me with the unusual opportunity not only to stay abreast of and participate in orthopedic developments in the United States but to stay on top of the orthopedic developments around the world. It is time I believe to adopt an Active Ageing approach to orthopedics in this country and that’s why my Blog has been so directed over the past 36 months.

It has taken us almost three years of study and global observation to allow for announcement of a Pilot Study for the treatment of arthritic joints with Bone Marrow Concentrate; now is the time. Last week, I used my Blog to announce the opening of  The Regenerative Pain Center with the sole purpose being an attempt at pain control through Regenerative Medicine in contrast to operative intervention. This week, I am announcing the start up of the first Pilot Study made possible because of the Regenerative Pain Center. A Pilot Study is the standard scientific tool for “soft” research, allowing me to conduct a preliminary analysis before committing to a full-blown clinical trial. I will investigate the validity of Bone Marrow Concentrate in treating arthritis of the hip or the knee in compliance with the FDA governance as described in CFR21 Part 1271 falling under the same day surgical exemption discussed in 1271.15(b).

To date, it has been patient testimonials and anecdote supporting regenerative medical care in the musculoskeletal system. That’s all changing, yesterday I received a new course announcement from the American Academy of Orthopedic Surgeons in Phoenix, April 20 to 22, titled Advances in Care of the Aging Athlete. Among the hot topics will be stem cell updates.The course will cover a broad array of topics, including degenerative, arthritic, and traumatic conditions that result from injuries, and take an expanded approach to the treatment of aging female athletes. I will use this course to help me better counsel active patients on managing their participation in sports as they age. Christopher J. Centeno, MD has gone further than anyone in this country, to the best of my knowledge, in advancing the regenerative field with his publication of Orthopedics 2.0.  How Regenerative Medicine will Create the Next Generation of Less Invasive Orthopedics.

My intent is to advance the scientific process with the introduction of a pilot study using Bone Marrow Concentrate in the hip and the knee. Next week I will focus on the several pilot studies and who qualifies.

Mitchell B. Sheinkop, M.D.

1565 N. LaSalle Street

Chicago, Illinois 60610

847-390-7666

 The Regenerative Pain Center

There is a very unique challenge concerning how to manage the effects of aging and the resulting impact on musculoskeletal well-being and continued participation in sports-from the weekend to the master athlete. Better understanding of the basic science of aging allows for better management of the physiological and biological issues and challenges facing the athletic baby boomer patient. The major problem as we age is weight gain despite a high level of activity and the same nutritional patterns as when we were younger. One must be aware that the body’s Resting Metabolic Rate (RMR) comprises 60-75% of daily energy expenditure and that RMR decreases 20% from childhood to retirement. The second major contribution to athletic decline is degenerative arthritis

The Basic Science of Aging :Implications for the Male and Female Master Athletes

We all must recognize the normal physiologic effects of aging and how our activities of daily living, work related undertakings, recreational enjoyment, and participation in sports are impacted. Are there appropriate non-operative treatment plans for patients with traumatic, degenerative, and arthritic conditions, particularly related to the knee, hip, shoulder and spine that might allow you to postpone or even avoid a joint replacement?

To address these issues, the Regenerative Pain Center (RPC) will open its Chicago doors next week with offices in Lincoln Park and Des Plaines; the sole purpose being an attempt at pain control through regenerative medicine. Is the timing right; is it premature? Last week, Dr. Jon Lapook on CBS NEWS Healthwatch reported on the experimental treatment Platelet Rich Plasma therapy, the procedure that appears to help heal a muscle, tendon or joint injury without surgery. Assessing the value of PRP therapy may be viewed at  

 http://www.cbsnews.com/video/watch/?id=7390747n&tag=mncol;lst;1

On page 3 of The Chicago Tribune/Business/Section 2/Friday, December 9, 2011 FOCUS STEM CELL THERAPY featured “Investors poised to pounce on a commercial breakout”. ”Early clinical trial successes of dozens of treatments bring hopes some will hit the market in 5 years.” To paraphrase, the promise of stem cells lies in their ability to repair tissue and reduce inflammation.  While the Food and Drug Administration has not yet approved unfounded claims of success with regenerative menu of offerings, the FDA does not interfere in the clinical practice of medicine as long as there are no unsubstantiated claims made. Next week, I will announce a Pilot Study using autologous bone marrow concentrate for the treatment of patients impacted by arthritis made possible because of the Regenerative Pain Center.

Mitchell B. Sheinkop, M.D.

1565 N. LaSalle Street

Chicago, Illinois 60610

847-390-7666

The overriding principal of medicine is First No Harm. When I was in residency training, I rotated for a year through the University of Utah. Incidentally, that was the year I turned 30 and bought myself a Schwinn bicycle 10 speed (orange $110); I started riding 10 miles each way to the Shriners Hospital instead of driving. My mentor used to teach by principles, not preferences. He taught me something that I have followed my entire professional career; never operate inside an adult’s hip joint unless you are going to replace it. The notion of bumpectomy is not new and was a failure in the 30s through the 80s. It was reintroduced via sports medicine and the arthroscopic surgeon. While there is an occasional anecdote of success, where the hip is concerned, I believe the population is being victimized. We are in an era when celebrity and marketing determine too much of the practice of orthopedics, the following article appeared in the New York Times. Space allows for only excerpts. 

New York Times Health THE Athlete’s Pain

Hip Procedure Grows Popular Dispite Doubt

By GINA KOLATA

Published: November 15, 2011

It is one of the most popular operations in sports medicine. It comes in various forms, all with the same name: Hip impingement or bone shaving surgery. World-renowned athletes have had the operation — the Yankees’ third baseman Alex Rodriguez had it about two years ago and the sprinter Tyson Gay had it last summer.

But some sports medicine researchers are asking: where is the evidence that shaving bone helps? Might the bumps or irregular shapes they call impingement be just normal variations? Does the shaved bone grow back?

And it is not just professional athletes who are having the operation. Now some surgeons are even operating on teenage athletes with hip pain.

The idea is that bone that has rough edges or an irregular shape in the hip is rubbing against soft tissue in the joint, causing tendons to fray or muscles to tear. The hope is that by shaving and smoothing the bone, surgeons can protect patients from further injury and also protect them from developing arthritis. The amount of bone removed varies but can be significant — sometimes, as much as a third of the femoral head and neck.

One difficulty in assessing the operation’s effects is that it is combined with other procedures to repair torn tissue. When patients say they feel better, is that because their impingement was fixed or because their torn tissue was repaired, or both? Another is that it takes years for arthritis to develop so it will take years for studies to determine if it has been prevented.

The combination surgery also complicates efforts to estimate the cost of the operations because it is billed under a variety of codes. The cost is also hard to evaluate because medical centers say that their charges are proprietary information. But at one academic medical center, the orthopedist’s charge for hip impingement surgery is about $4,400. The doctor’s charge to repair torn cartilage is an additional $4,400. Hospital charges are extra, as are charges for the months-long rehabilitation.

Yet despite the popularity of hip impingement surgery, said Dr. Harry E. Rubash of Harvard Medical School, “no one has really proven that it is uniformly helpful to the patient.”

Dr. Freddie H. Fu, chairman of orthopedic surgery at the University of Pittsburgh School of Medicine, said he had sought more evidence. “I challenge these people all the time,” he said. “I’m all for progress in medicine, but I want to do it right.”

But researchers say many questions remain. Among the most pressing is whether the procedure prevents arthritis.

Mitchell B. Sheinkop, M.D.

1565 N. LaSalle

Chicago, Illinois 60610

847-390-7666 or 312-475-1893