Posts Tagged Stem Cells
Hand Surgery Alternative for Arthritis and Injury
Posted by Mitchell B. Sheinkop, M.D. in Hand, Osteoarthritis on February 21, 2012
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
Stem Cells and the Lawsuit That May Shape Our Medical Future
Posted by Mitchell B. Sheinkop, M.D. in Stem Cells on February 14, 2012
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.
An experimental treatment offered for sale is not the same as a clinical trial.
Posted by Mitchell B. Sheinkop, M.D. in knee, Osteoarthritis, Platelet Rich Plasma, Regenerative Pain Center, Stem Cells on February 6, 2012
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
Stem Cell Crier
Posted by Mitchell B. Sheinkop, M.D. in Regenerative Pain Center, Stem Cells on January 30, 2012
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
On Proteins, PRP, Bone Marrow Concentrate, Stem Cells and Orthokine
Posted by Mitchell B. Sheinkop, M.D. in Platelet Rich Plasma, Regenerative Pain Center, Stem Cells on January 4, 2012
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?
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What’s in Bone Marrow Concentrate: Both pro- and anti-inflammatory cytokines and the factors: Fibroblast Growth Factor-b, PDGF-AB, TGF-B, and VEGF. |
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
