Jan 9, 2014
If you access www.ClinicalTrials.gov, a service of the U.S. National Institutes of Health, next week, you will learn of a new clinical study concerning measurement of outcomes in the minimally invasive treatment of knee arthritis. Adult Mesenchymal Stem Cells derived from Bone Marrow that are concentrated and prepared using updated technology is the basis for Regenerative Sciences, LLC Center sponsoring the Trial. The other reason, about six months ago, I changed the discussion concerning outcomes measurements of cellular orthopedics interventions for knee arthritis when I compared my results at one year of stem cell regenerative therapy with my historical results of knee replacement surgery. That paper, delivered at an international stem cell conference, while changing the discourse in the regenerative medicine world, also catalyzed argument among the joint replacement surgeons about the role of stem cells for arthritis of major joints. One valid criticism of my scientific clinical trial was that there had only been a one-year follow-up. The second, a relatively low number of patients in that first of its kind study. The net result is an approval announcement from the Institutional Review Board of the International Cellular Medicine Society: Randomized Controlled Trial of Regenexx SD Versus Exercise Therapy For Treatment of Knee Osteoarthritis with Historical Comparison To Total Knee Arthroplasty.
As in any clinical trial, there are inclusion criteria that must be met before a patient would be considered a candidate for the stem cell intervention. The study itself has IRB restrictions as well. Beside the many benefits of cellular orthopedics for osteoarthritis of the knee, just as anything else in health care, there are Risks and Discomforts. You may become familiar with The Regenexx SD procedure by accessing that web site www.Regenexx.com or when you are seen in my office. There are no experimental tests or procedures in this study. Before a candidate gains entrance to the study, the following procedures are required to evaluate eligibility:
- A knee examination
- Documentation of medical and surgical history and medication usage
- Review of current images (X-rays)
Costs
While there will be no charge for the Pharmacologic portion of the trial (Stem Cell management), study participants or their insurance may be billed for:
- The initial physical evaluation/consultation
- Follow-up office visits after the procedure
- Knee brace if requested
Are you interested and do you meet the inclusion criteria? To learn more call 1-888-525-3005 or contact [email protected]
Tags: arthritis, Clinical Trial. Mitchell B. Sheinkop, Knee, Knee Pain Relief, Orthopedic Surgeon, Osteoarthritis, Regenexx-SD
Dec 30, 2013
What prompted the subject matter for this blog is the article appearing in the December 25, 2013 issue of the New York Times by Pam Belluck: Common Knee Surgery Does Very Little for Some, Study Suggests. What the writer is citing is a scientific article that appeared in The New England Journal of Medicine “suggesting that thousands of people may be undergoing unnecessary surgery”. The study reported from Finland recognized that about 80% of tears seen on the MRI of patients develop from wear and aging. In the study patients were randomized with some undergoing arthroscopy and the others having a sham operation. All received physical therapy. A year later, most patients in both groups felt the same.
Assume if you will that you are seen in my office for knee pain without a history of a major athletic trauma. My first question, “ Are you having mechanical symptoms; that is clunking, locking or giving way? Before I write the prescription for the MRI, a complete orthopedic history and a physical examination is performed. Our research at Regenexx has documented that the treatment recommendations for adult non-traumatic knee pain should be based on the history and the physical findings, not on the MRI alone. The physical findings of significance include the range of motion and the mechanical axis. Is the patient developing inability to fully straighten, symmetrically bend, bow leg or knock-knee? Next comes the request for the imaging.
Based on the results of history, physical examination and imaging, I propose a therapeutic approach almost always beginning with physical therapy. I might suggest an ultrasound guided cortisone injection to control discomfort for more effective PT. When the X-rays and MRI are reviewed, I more often than not will discover a torn meniscus of some type with degenerative arthritic changes elsewhere in the joint. The treatment will be directed to the entire arthritic process and not targeted to the frayed meniscus. That’s what I have been doing over the last ten years and that’s what the Finnish study confirmed is the correct approach. More likely than not, the next step will be a visco-supplementation program.
With an emphasis on advancing the care of the aging athlete, you will receive an informed consent regarding cellular orthopedics based on stem cells, should the aforementioned measures not succeed. While Regenerative Medicine is not presently indemnified by Medicare or the private insurer, compared to your anticipated out of pocket expenses in the new world of affordable insurance, your costs for symptomatic relief from arthritis while actually reversing the degenerative process will be comparable to that which you will have to pay for hospitalization or out of network care starting in 2014.
Having introduced the New Year, what are so exciting will be the next initiatives taking place in the processing of Bone Marrow Aspirate Concentrate. We now have the technology to increase the number of stem cells available by a 7X to 200X multiple via a revolutionary development of how we manage the bone marrow in the laboratory prior to injection into your arthritic joint. Have a happy and healthy 2014 and just call to learn more about advances in the aging athlete.
Tags: arthritis, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, Knee, medicine, Orthopedic Surgeon, Regenerative Pain Center, stem cells
Aug 1, 2013
I had cause recently to review our application for The Autologous Bone Marrow Concentrate Outcomes Research Project that was approved by the Institutional Review Board on March 9, 2012. The Clinical Study Background stated, “ While the knowledge of cellular and molecular mechanisms of stem cells has been increasing at an exponential rate, clinical progress in the related management of arthritis has been minimal. Bone Marrow Concentrate contains elements directly capable of promoting regenerative potential and decreasing ongoing inflammation.”
Osteoarthritis and Stem Cell Therapy
The scientific approach for our stem cell research project was based on the fact that Bone Marrow Concentrate is known to contain mesenchymal stem cells (MSC), hematopoietic stem cells (HSC) and other progenitor cells. This rich community of cells has regenerative properties, immune response modification capacity and ability to generate growth factors. While our clinical emphasis to date has been on regeneration and the anti-inflammatory possibilities, what we have neglected to emphasize is the potential of slowing the progressive of degeneration usually seen in Osteoarthritis. Simply stated, our goal is to relieve pain, promote healing and modify progression. You may conclude, the outcome will be better if the Stem Cell intervention is earlier in the onset. On the other hand, please recognize that maximum medical improvement may not be reached until 18 months after a BMAC procedure. It is increasingly evident that the patient population has not taken home that latter message.
I will attempt to help a potential patient with, or remind an exiting patient about milestones after a Bone Marrow Concentrate Procedure. First and most important, if you haven’t moved on to a joint replacement, you’re enjoying a satisfactory outcome. At six weeks, certainly it would be great if your pain and swelling were gone but that might not happen for three to six months after the fact. Even I get impatient, which is why I will offer a booster Platelet Rich Plasma if the goal isn’t met. I remind you and need to remind myself that the final end point may not be reached until 18 months.
How might a patient do better faster? If you check out the Regenexx web site at WWW.Regenexx.com, there is a new listing about The Regenexx Advanced Stem cell Support Formula purported to ”help support healthy stem cell function and cartilage production”. Please do not take this as an endorsement of product. It is strictly informational and I receive nothing in return, though I hope it helps.
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Osteoarthritis, stem cells, treatment
Jun 12, 2012
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.
Tags: Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Hip, Interventional Orthopedics, Knee, medicine, Orthopedic Surgeon, Orthopedics, Pain Management, Regenerative Pain Center, stem cells
May 1, 2012
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
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Osteoarthritis, stem cells, treatment
