Jul 7, 2016
From the AMA News, July 1
Good Morning Dr. Mitchell Sheinkop. Here are today’s top stories.
Leading the News:
Unproven stem cell therapies available at hundreds of US clinics
In “Science Now,” the Los Angeles Times (6/30, Kaplan) reports that research indicates across the US, “at least 351 businesses at 570 locations are marketing stem cell therapies that have not been fully vetted by medical researchers or blessed by the” FDA. The findings were published by Cell Stem Cell.
On its website, NBC News (6/30, Fox) reports that the FDA “regulates some stem cell treatments and says there’s almost nothing available as a commercial product.” However, the agency “does not regulate stem cells taken from a patient and reinfused back into the patient, so long as they’re changed or manipulated.” According to NBC News, “Many of the clinics on the list offer these non-regulated types of treatments.”
In “To Your Health,” the Washington Post (6/30, McGinley) reports that this “analysis comes as the debate over regulating stem-cell clinics is intensifying.” Although “some critics say the FDA should crack down on the industry, others say they shouldn’t face new restrictions because what they are doing is part of the ‘practice of medicine.’”
Bloomberg News (6/30, Ramkumar) points out that “the FDA has issued draft guidelines for stem cell therapies and is planning a public hearing in September on regulating procedures.”
I am in 100% agreement with the AMA’s Leading News review. Yesterday, a very well known retired professional athlete sought consultation in my office concerning a regenerative intervention for his arthritic left hip. During the intake, the remote traumatic event leading to the progressive arthritic limitations could be identified. Earlier this year, we witnessed the retirement of Kobe Bryant from professional basketball and I was reminded of the stem cell procedure he underwent in Germany five years ago for a “bone on bone” arthritic knee. That interventional orthopedic procedure added five years to his career. Outcomes that we capture, as well as those of other board certified clinicians, support Bone Marrow Concentrate/Stem Cell intervention for grades two and three, sometimes grade four osteoarthritis. The 351 businesses marketing stem cell therapies for every known malady of mankind deserve an industry crack down by the FDA. I am a board certified orthopedic surgeon with outcomes and data to support my practice of improving the well being of patients afflicted by arthritis in a major joint.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
Jun 30, 2016
Out is routine Medicare and insurance coverage indemnification of hyaluronic acid injections for osteoarthritic joints other than the knee. Additionally, several insurance carriers are now requiring pre-certification to determine if they will even cover hyaluronic acid injections of the knee. The phenomenon was first reported in Florida but now the reduction in coverage is spreading across the country including Illinois. A physician may decide to proceed with the single, thee part or at times five part injection series but it would be at the expense of the patient if insurance and Medicare deny coverage. The reason behind the decision has to do with long-term studies that fail to validate the claims of the many advertisements you may see on television or find in the newspaper concerning the various forms of hyaluronic acid as a gel.
Increasingly in is Amniotic Fluid Concentrate for Osteoarthritis even though not covered by Medicare or Insurance. The clinical trial regarding outcomes for said therapy are incomplete; and to the best of my knowledge, the only source of Amniotic Fluid Concentrate providers seriously investigating results is MiMedx, out of Marietta, Georgia. Nevertheless, there seems to be an ever-increasing presence of Amniotic Fluid Concentrate offerings in the medical marketplace; unfortunately with unsupported claims of a stem cell content. There does seem to be a benefit from amniotic fluid concentrate in relieving the symptoms of an osteoarthritic joint but we have to wait for completion of current clinical trials to understand proper dosage and the length of action.
If you are a regular reader of this Blog, you will have become familiar with the term Subchondroplasty, an adjunct that I have been offering on occasion in conjunction with Bone Marrow Concentrate/Stem cell procedures into the joint. The successes of Subchondroplasty are such that the attention to the bone supporting the joint when working inside the joint is a subject gaining increased attention on a national basis. It looks like the future will be an increasing combination of both intra-articular and extra-articular intervention. While no one is able to confirm why the decompression of the bone adjacent to a joint relieves pain and why the adjunct of biologics improves longer-term outcomes, attention to bone defects in the area around the joint is proving to make a major difference in outcomes for arthritis. The question now is whether the best approach is Bone Marrow Concentrate inside and outside the joint or Bone Marrow Concentrate inside the joint with a synthetic augment outside the joint?
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx-SD, stem cells, Subchondroplasty, treatment
Jun 8, 2016
In the late summer of 2015, I was featured on a Fox cable news segment featuring a patient on whom I had performed a Bone Marrow Aspirate Concentrate –Stem Cell intervention coupled with a subchondroplasty procedure. The patient had experienced a poor result from a right Total Knee Replacement years earlier and was seeking a means of improving function and minimizing her left knee pain resulting from arthritis. Cartilage does not have a nerve supply so scientists and clinicians have long sought a clear understanding of the pain generator in osteoarthritis. While there still is not a clear-cut consensus, many clinicians are looking at the bone marrow lesions seen on an MRI when taken of an arthritic joint as the possible cause of pain associated with arthritis.
In the case of my patient, the combined BMAC-Stem Cell procedure coupled with the subchondroplasty had resulted in a very satisfactory outcome and such maintains at this time to the best of my knowledge. What was unique about my patient was the use of Bone Marrow Concentrate-Stem Cells to serve as the catalyst to effect healing of the bone marrow lesions. Up until that time, surgeons were using a synthetic calcium phosphate material to fill the defects above and below a joint surface with a mandatory three months of protected weight bearing and six months of altered physical activity. The introduction of Bone Marrow Concentrate with Stem cells required 48 hours of crutch support and six weeks of restricted physical activity.
My patient who received media attention served to foster a debate in the medical device industry as to the superior methodology serving as an adjunct to a subchondroplasty. First came the initial trial using a subchondroplasty procedure and synthetic filler with the inherent need for prolonged altered function and assisted ambulation. Now there are several clinical trials in development pertaining to an arthritic joint and the minimally invasive, percutaneous subchondroplasty comparing the synthetic filler to the Bone Marrow Aspirate Concentrate-stem cell adjunct; with the latter used both inside the joint and in the adjacent subchondral bone.
Are your arthritic joint changes affecting both the cartilage and the supporting bone? Is the actual source of your joint pain, the supporting bone or bone marrow lesions adjacent to the hip, knee, ankle or shoulder? It would require a complete examination and review of X-rays and an MRI for me to answer the question and advance the most appropriate therapeutic recommendation. Could it be that the failure of a regenerative intervention wasn’t a failure of the stem cells but rather a failure to address the real pain generator, subchondral bone?
Call for an assessment 312 475 1893 and I will try to answer that question.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, Subchondroplasty, treatment, Ultrasound Guided Injection
Apr 18, 2016
Articulate cartilage has little to no capacity to undergo spontaneous repair because it has no blood supply nor is it able to regenerate across a physical gap. In order to restore cartilage in a skeletally mature patient, there is a need for outside help. In some settings, osteochondral transfer (bone with cartilage) may be harvested from elsewhere in a damaged joint and repositioned or relocated in that joint. In other settings, fresh cadaveric tissue (allograft) may be used. More recently, attempts have been directed at “engineering” cartilage. For engineering to take place, there are three requirements. First must come a matrix scaffold necessary to support tissue formation. Second are cells such as mesenchymal stem cells either from bone marrow or synovial membrane lining the joint. Third comes signaling molecules (cytokines) and growth factors. Platelet Rich Plasma is a source of signaling molecules. While Bone Marrow Concentrate doesn’t meet every need for tissue engineering, to the best of my knowledge at this time, there is nothing superior for a long term successful outcome either as an adjunct to a surgical procedure for a small defect or as a primary intervention for an arthritic joint.
There are several ways to measure success after an attempt at cartilage repair. For a contained or global defect, MRI is the primary outcome measure; whereas for osteoarthritis, the Outcome objective metrics I use have proven statistically significant and reproducible. I write this Blog in between presentations by the faculty at American Academy of Orthopedic Surgery Program: Articular Cartilage Restoration-The Modern Frontier. I came here to learn and learn I did about surgical procedures for contained injury. When it comes to osteoarthritis, I learned little but contributed much. No, I am not being egotistical, I am reporting what transpired at the meeting and what is transpiring in my practice. Of interest is the universal agreement by those treating the global defect with surgery and those of us who treat osteoarthritis with stem cells; including the supporting bone ( bone marrow edema)in the therapeutic algorithm via subchodndroplasty is paramount.
“He, who has data, need not shout”
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, Regenerative, Regenexx, stem cells, treatment
Mar 28, 2016
Cartilage damage may result from trauma, repetitive motion/impact, abrupt abnormal weight bearing, fractures, wear/degeneration, joint infection, meniscectomy, friction/abrasion due to abnormal joint alignment, inflammatory diseases or a genetic predisposition to name a few reasons. The primary symptoms are pain, loss of motion and functional impairment.
As a form of connective tissue that is very primitive from an evolutionary standpoint, cartilage does not lend itself to intrinsic repair. All the attributes required for healing, while present in bone, are missing in cartilage including blood vessel supply, pain fibers, regenerative cells, fluid balance, and a rich source of nutrition. The cartilage in your joint is not populated by metabolically active cells nor is the chondrocyte capable of positively influencing its own environment. In keeping with all of the principal shortcomings of cartilage, chondrocytes do not replicate after age 40 and cannot migrate.
Because articular cartilage damage from any of the aforementioned causes is permanent and progressive, it is paramount that intervention takes place early in the degenerative process or soon after injury. The likelihood of a successful, enduring repair or restoration diminishes as generalized cartilage deterioration progresses.
There are many palliative interventions available such as weight loss, non-steroidal anti-inflammatory medication, shoe wedges, off-loader braces, cortisone injections, gels/visco-supplementation, and most recently, amniotic fluid concentrates. Missing though from all of these options is the regenerative potential. Bone Marrow Aspirate Concentrate not only introduces regenerative potential via adult mesenchymal stem cells, it is a huge resource for anti-inflammatory molecules termed cytokines. Equally important though are the extracellular vesicles (exosomes) termed growth factors. What about adipose derived stem cells and cultured stem cells?
While adipose tissue contains stem cells, the latter are not available unless liberated from their surroundings. An enzyme, collagenase has been the necessary ingredient but the use of collagenase is interpreted as tissue manipulation and thus not allowed by the FDA. While there was an introduction last July of a mechanical means of liberating stem cells from fat graft harvest, there are no outcomes as of yet to support said alternative. At the same time, while adipose derived stem cells have been used outside of the US, there are no studies indicating better outcomes with adipose derived cells as compared to bone marrow derived stem cells. The remaining question at this time is whether the results of cultured stem cells are superior to Regenexx SD outcomes. While there is anecdote, we have no Evidence Based Information to help guide Clinical Appropriate Use Criteria.
With all the above written, I am done for today; if you are still unclear or uncertain, call the office for an appointment.
847 390 7666
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Mar 21, 2016
Physicians should be in a constant state of education to keep their skills and knowledge at the forefront so that their patients get the best care possible. At the same time, I personally have devoted over 40 years to integrating patient care with research and education be it directed to joint replacement, and for the past four years, to postponing and at times, avoiding joint replacement. As the vast majority of health professionals, I strive on a daily basis to meet the need of my patients. Each and every patient for whom I provide care is entered into a HIPAA compliant outcomes database. From time to time, results are extracted from that data-base and presented at Cellular Orthopedic meetings. Soon we will be submitting the outcomes of several clinical trials for statistical analysis and publication. Almost every therapeutic intervention I recommend is based on science and statistically significant outcomes; rarely on anecdote.
The emerging field of regenerative medicine aims to deal with arthritis and cartilage injury by providing the required elements (cells, inductive molecules, and local environment) to promote true joint and cartilage regeneration. Cellular Regenerative Medicine is rapidly evolving and changing on an almost weekly basis. This is both good news and bad news as there are those who would try to prosper through marketing rather than science. Witness the invitation I received last week to travel to the Bahamas for stem cell care based on anecdote; or the advertisement for the “opportunity” to attend a weekend course to teach me how to use adipose tissue for every malady in the human body. How is it possible to track outcomes from medical tourism or to teach adipose related cellular orthopedic intervention when the latter is not FDA approved?
To assure you that I remain in the forefront of Cellular Orthopedics, from March 31-April 2, 2016, I will be participating in a Continuing Educational course, Articular Cartilage Restoration: The Modern Frontier, sponsored by the American Academy of Orthopedic Surgeons. This is a premier skills course that provides hands-on exposure and practice for the most updated techniques in cartilage restoration while allowing for a contemporary overview of established and new procedures to treat the entire knee joint for cartilage damage ranging from focal defects to arthritis.
Although I no longer am involved with orthopedic resident education, as Professor Emeritus at Rush, I have taken the Interventional Orthopedics Foundation pledge to continue to integrate my clinical interventions with outcomes surveillance. Several scientific presentations at the early March meeting of the American Academy of Orthopedic Surgeons resulted because of my ongoing initiatives. I am the orthopedic surgeon who four years ago, exchanged a scalpel for a stem cell.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Hip, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
