Jul 18, 2016
For those new to this Blog, my focus on Regenerative Medicine has just started its fifth year. Prior to that time, I was an orthopedic surgeon surgically replacing hips and knees at a major academic Chicago Medical center for almost 40 years. I then graduated into Regenerative Medicine where I have dedicated the past four years helping patients avoid or at least postpone when possible, a joint replacement for an arthritic hip, knee, shoulder or ankle. You may have learned from that previously written, during my joint replacement years, every patient undergoing a hip or knee replacement became part of a comprehensive database wherein by integrating research with patient care, I would continue to stay in the forefront of reconstructive orthopedics. I would present my findings at various orthopedic seminars around the world and share my knowledge with interested orthopedic surgeons so they could determine the best prostheses, the best surgical approaches, the best rehabilitation techniques, how to prepare a patient for a procedure, and how to achieve the best possible outcome both functionally and from the standpoint of survivorship of components.
When I entered the emerging discipline of Interventional Orthopedics, I introduced my knowledge of orthopedic research as well as my support team, adapting joint replacement clinical research methodology for stem cell intervention outcome surveillance. Owing to my long tenure as a clinician and my Emeritus Professorship designation, many now are seeking my advice and counsel on how to maximize outcomes from a Bone Marrow Concentrate intervention in an arthritic joint. All this being said, within the last several days, I have provided stem cell consultation to a retired professional baseball player of note, and to a medical tourist from the United Arab Emirates, where I had taught joint replacement surgery over 11 times between 2001 and 2007. Today, my office received a call requesting a consultation from a family of Turkish tourists visiting Chicago. Between 2002 and 2006, I had visited Turkish Orthopedic Centers in Izmir, Ankara and Istanbul to demonstrate hip and knee replacement procedures while also lecturing on five separate occasions by invitation around the country.
The point is that there are those of us who are qualified intellectually, experientially, and clinically to assist the patient limited by arthritis of a major joint using Evidence Based Medicine for stem cell care; while there are those who recruit patients by placing a marketing ad with unsupported claims in the media. If you want a consultation based on Best Regenerative Medicine Practices, call for that consultation: 312 475 1893
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Clinical Studies, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Regenerative, Regenexx, treatment
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
May 12, 2016
You may have seen this subject matter before but research and everyday experience reminds me that one has to hear the informed consent three times for the best retention.
Clinical translation of regenerative medicine technologies requires a source of stem and progenitor cells and growth factors. The most success in Cellular Orthopedics to date has come from Bone Marrow Aspirate Concentrate wherein concentrations of mesenchymal and hematopoietic stem cells and soluble growth factors are recovered, concentrated and the joint intervention shortly follows. The procedures we use offer an FDA-compliant means of concentrating autologous stem and progenitor cells, platelets and growth factors to be used in the treatment of osteoarthritis of a joint. In a single event, we may introduce a means of pain relief, increase joint motion, improve activity and quality of life, reverse osteoarthritic changes on a bio-immune basis and possibly affect joint regeneration.
The standard of Regenerative Medicine remains Bone Marrow Aspirate Concentrate; the most studied approach in clinical practice. I am aware of the option of Fat Graft Harvesting, Micro-fracture of the Fat Graft and injection of the emulsified adipose tissue into a joint; but to the best of my knowledge at this time, the clinical outcomes results are no longer than 90 days, so stay tuned or just keep reading my Blog to update.
Platelet Rich Plasma preparation process certainly has improved over the past several years and now allows for protein and growth factor concentrating but with the notable absence of the Progenitor Cells ( Mesenchymal Stem Cells, Hematopoietic Stem Cells, etc.)
Amniotic Fluid Concentrate has recently gained traction in the clinical practice setting as a replacement for Hyaluronic Acid derivatives or synthetic alternatives but the clinical results are only now being studied. I have said it before and I will emphasize, there are no living Stem cells in Amniotic Fluid Concentrate after sterilization and processing. That is not to say, AFC is not a superior option with a longer lasting pain relieving anti-inflammatory benefit to Hyaluronic acid based offerings.
There is no test now that you have studied my Blog but hopefully you are more familiar with Regenerative Therapies. As part of my Clinical Practice, we have developed the Center for Clinical Investigation. To learn what might best suit your needs, call 847 390 7666 and schedule a consultation.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
