Archive for category Stem Cells
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
FDA Warning on Stem Cells
Posted by Mitchell B. Sheinkop, M.D. in Osteoarthritis, Regenerative Pain Center, Stem Cells on January 12, 2012
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
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
Stem Cell and Adjunctive Therapies
Posted by Mitchell B. Sheinkop, M.D. in Stem Cells on December 20, 2011
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
Platelet Rich Plasma and Stem Cell Update
Posted by Mitchell B. Sheinkop, M.D. in Platelet Rich Plasma, Stem Cells on November 1, 2011
In case you missed it, The Good Morning America Reporters Notebook by Ron Claiborne Oct. 24, 2011 started out “How to Best Manage Your Back Pain.” You may see the entire program at
Basically, it is a program devoted to introduce the notion of using Platelet Rich Plasma in lieu of steroids for an epidural as has become popular in Europe. The claim is that while an epidural steroid injection may benefit a patient for weeks or months, a PRP epidural will have benefit for years. Golf legend, Fred Couples who won the prestigious PGA Senior Players Championship August 28, despite being sidelined on-and –off the past five years revealed that the secret to his success was a trip to Germany for Regenokine treatment, the injection of autologous platelet rich plasma into the epidural space. The U.S. Food and Drug Administration has not given approval for the treatment to make the claim of effectiveness for osteoarthritis or back pain. The usual and customary cliché holds, “more studies are needed”. Yet there is growing evidence to support the usage of PRP and Bone Marrow Concentrate in pain management. For one, it is a usual and customary practice in Europe and the regulatory bodies in the European Union are not that dissimilar for those in the United States. As I have written about over the past several months in this blog, I soon hope to identify the orthopedic corporate sponsors that will enable me to introduce the IRB regulated clinical studies based on autologous Platelet Rich Plasma and Bone Marrow Concentrate in my clinical practice. In spite of the apparent restrictions from governmental scrutiny, I am amazed by the speed with which the entire American Orthopedic Corporate community is embracing the science and actual clinical offerings to enable PRP and Bone Marrow Concentrate introduction in orthopedic practice. My professional meetings continue to identify the best opportunities, as does my gathering of information concerning the risks and benefits of orthobiologic potentials. I think I will be there by the end of the year.
Mitchell B. Sheinkop, M.D.
847-390-7666
1565 N. LaSalle Street
Chicago, Illinois 60610
Top Nine Things to Know About Stem Cell Treatments
Posted by Mitchell B. Sheinkop, M.D. in Stem Cells on October 25, 2011
Musculoskeletal Care of the Mature Patient
1. There are different types of stem cells—each with their own purpose.
The different types of tissue-specific stem cells come from different places in our body and each has a special purpose. Tissue-specific stem cells are limited in their potential. For example, the blood-forming stem cells (or hematopoietic stem cells) in the bone marrow regenerate the blood, while skeletally derived stem cells are responsible for bones and joints.
Be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated.
2. A single stem cell treatment will not work on a multitude of unrelated diseases or conditions.
It is unlikely that a single type of stem cell treatment can treat multiple unrelated conditions, such as diabetes and Parkinson’s disease. It is critical that the cell type used as a treatment be appropriate to the specific disease or condition.
A major warning sign that a clinic may not be credible is when treatments are offered for a wide variety of conditions but rely on a single cell type.
3. Currently, there are very few widely accepted stem cell therapies.
The range of diseases where stem cell treatments have been shown to be beneficial in responsibly conducted clinical trials is still extremely restricted. Now you may better understand my caution in offering stem cell management of arthritis and why I insist on a clinical trial format
4. Just because people say stem cells helped them doesn’t mean they did.
There are three main reasons why a person might feel better that are unrelated to the actual stem cell treatment: the ‘placebo effect’, accompanying treatments, and natural fluctuations of the disease or condition. The intense desire or belief that a treatment will work can cause a person to feel like it has and to even experience positive physical changes, such as improved movement or less pain.
Be wary of clinics that measure or advertise their results primarily through patient testimonials.
5. A large part of why it takes time to develop new therapies is that science itself is a long and difficult process.
If a treatment has not been carefully designed, well studied and gone through the necessary preclinical and clinical testing, it is unlikely to have the desired effect.
6. To be used in treatments, stem cells will have to behave in specific ways.
For arthritis, one of the greatest barriers to the development of successful stem cell therapies is to get the cells to behave in the desired way. Will an autologous, marrow derived adult mesenchymal stem cell grow cartilage? That’s why my demand for a clinical study as a means of introducing stem cell management.
Be wary of claims that stem cells will somehow just know where to go and what to do to treat a specific condition.
7. Just because stem cells came from your body doesn’t mean they are safe.
Every medical procedure has risks. While you are unlikely to have an immune response to your own cells, the procedures used to acquire and deliver them are potentially risky; hence FDA concerns.
8. An experimental treatment offered for sale is not the same as a clinical trial.
The fact that a procedure is experimental does not automatically mean that it is part of a research study or clinical trial. My oversight will be an Institutional Review Board.
Beware of expensive treatments that have not passed successfully through clinical trials.
9. Stem cell science is constantly moving forward.
Stem cell science is extraordinarily promising; and that’s why I am tremendously optimistic.
Mitchell B. Sheinkop, M.D.
847-390-7666
1565 N. LaSalle Street
Chicago, Illinois 60610
PRP, Stem cells or Surgery
Posted by Mitchell B. Sheinkop, M.D. in Platelet Rich Plasma, Regenerative Pain Center, Stem Cells, Uncategorized on October 4, 2011
To operate or not to operate?
Although Joint Replacement Surgery is a fairly predictable and cost-effective intervention for severe osteoarthritis of a major joint, it is not necessarily the treatment of choice for everybody. There are issues surrounding the decision-making process for surgeon and patient. Treatment should begin with most basic options and progress to the more involved as not all treatments are appropriate for every patient. Not everybody gets better after a total hip or total knee replacement. An important minority estimated at 10%-20% does not improve or are made worse by surgery. Then there is the population of patients who have associated conditions, co-morbidities, which prevent them from undergoing a surgical procedure without severe medical risks.
Try Nonsurgical Therapy First
While orthopedic surgery is based on allopathic medicine, that is the scientific process; the key to good decision-making about whom should have a joint replacement should be a holistic approach. Weight Reduction is paramount; anything greater than a BMI of 25.5 will result in excess loading of your hip and knee. Activity modification is strongly recommended using a bike and the swimming pool for exercising, Low-impact aerobic fitness, range of motion and flexibility exercises, muscle strengthening, and core strengthening. I find a patellar stabilizing knee sleeve to be very valuable, the one with the hole in the center. Acupuncture, glucosamine and chondroitin sulfate still are homeopathic. While there seems to be a greater than 50% positive response to visco-supplementation in the knee, the American Academy of Orthopedic Surgeons will not endorse this approach. There is no question that intra-articular corticosteroids offer short-term pain relief both in the hip and the knee.
Arthroscopy
Not advised for debridement of an arthritic hip. The same holds in the primary diagnosis of symptomatic osteoarthritis of the knee. On the other hand, there is a place for partial meniscectomy or loose body removal when the primary symptom arises in the presence of osteoarthritis.
Orthobiologics (PRP and Stem Cells)
We do not yet know exactly who may benefit from platelet concentrate or bone marrow concentrate and which factors are most critical in assuring the best possible outcome. Even the exact scientific explanation for how stem cells really work is still in the works. Preoperative severity of arthritic disease is probably most important. At this time, the decision to undergo an ortho-biologic procedure is about balancing potential benefits against potential risks. Given the fact that the biologic is autogenous and confined to a major joint, the significant risk is infection; that’s the risk of any invasive procedure and exceedingly rare to date. The case studies suggest that the new world of stem cells is worth consideration before a joint replacement
Stem Cell Vignettes
Posted by Mitchell B. Sheinkop, M.D. in Stem Cells on September 27, 2011
Indianapolis Colts quarterback Peyton Manning has reportedly undergone a stem cell treatment in Europe because of a neck injury that is so far this season keeping him off of the field and on the sidelines, according to news reports. Manning is currently suffering from nerve injury secondary to cervical disc disease; he has undergone surgery several times to correct the damage without success.
Manning’s treatment is not approved in the United States, and involves using the four-time MVP’s own fat cells to regenerate the nerves around his neck, AOL Sporting News reported.
The New York Daily News reported that Manning underwent another neck surgery after undergoing the stem cell treatment.
Athletes are allowed to undergo stem cell therapies “unless a banned substance is used as part of the procedure,” an NFL spokesman told The Daily News.
Popular Science reported that Manning probably underwent a stem cell procedure involving induced pluripotent stem cells, which “can be reprogrammed to become any type of cell.”
Manning’s treatment is raising the eyebrows of some doctors, who say that the treatment doesn’t have any scientific evidence to back it up, ABC News reported. There are also concerns about the message Manning is sending to the public.
T.O visits Korea for stem cell treatment of torn A.C.L.
Terrell Owens, refusing to abandon his attempt to return to the NFL, has traveled to Korea for treatment on the anterior cruciate ligament he tore during the offseason.
“Mr. Owens starts with therapy Monday, followed by the collecting and storing of his stem cells the next day,” Dr. Lee Jung-no, president of the Chaum Anti-Aging center, told the Korea Times on Monday.
Owens, 37, visited the center at the recommendation of renowned specialist Dr. James Andrews.
“Owens becomes the second big-name player to travel abroad for stem cell-related therapy after Colts QB Peyton Manning went to Europe for a procedure before his most recent neck surgery.
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