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 13, 2016
Just as I hope to improve patient activity with delivery of Bone Marrow Concentrate (BMC), Stem Cells and Concentrated Growth Factor for grades 2 and 3 osteoarthritis, might the success of a surgical procedure at the time of the initial trauma be significantly improved by the adjunct of BMC, Stem Cells and GFC thereby heading off a suboptimal response to an initial trauma surgery? Clearly, being driven as medical practice is in the US; that is to assess pain and then determine the anatomical treatments to relieve that pain has to change. It would make more sense for the surgeon to examine the “flaws” in anatomy, and judiciously treat with BMC before the flaw leads to frank pain and other issues. There is a need for the preemptive integration of Cellular Orthopedics in both the early arthritis and traumatic environments.
Bone bruises and bone edema are grossly under treated in the current orthopedic paradigm. If we would offer patients a Bone Marrow Concentrate intervention at the time of injury or in conjunction with surgery, it is possible, actually likely, that progression to higher arthritic scores will be greatly delayed.
To put things in a proper perspective, most patients expect an improvement of physical activity after total knee replacement. In a Feature Article How Much Improvement in Patient Activity Can Be Expected After TKA?, from a major university center in Germany, only 22% of TKR recipients met health-enhancing physical activity (HEPA) guidelines and only 31% achieved an active lifestyle. In contrast, our data indicates that greater than 70% of our patients who have undergone a bone marrow concentrate/stem cell intervention for osteoarthritis are active in recreational athletics and fitness pursuits including skiing, cycling, golfing, dancing, hunting, fly fishing, basketball, etc.
You the patient have to determine how to proceed and become an advocate for your own arthritic care be it interventional or preemptive. Clearly, the orthopedic surgical and sports medicine communities are behind in integrating orthobiologics into treatment protocols. To stay ahead and learn more be it arthritis or a recent injury requiring surgical repair, consider a cellular orthopedic consultation 312-475-1893 to schedule an appointment.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, 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
May 2, 2016
Bob Dylan released his third studio album The Times They Are A-Changin’ in 1964; but history was in a constant state of flux before and Regenerative Medicine continues to evolve. While I am concerned about devolution in our civility and world; that’s outside the scope of my medical Blog and I will leave Gulliver’s Travels to Jonathan Swift. Returning to the thrilling Interventional Orthopedic days of now and the future, how might we improve Cellular Orthopedic outcomes? Be reminded that Regenerative Therapies for now are and have been based on rapid concentration of your (autologous) progenitor cells, platelets, growth factors and proteins. Change in Regenerative Medicine is difficult and must meet stringent FDA criteria. I am thrilled to announce that this past Friday, I received preliminary IRB approval for my protocol VQ-501-K wherein pulsed electrical stimulation will be added to the Bone Marrow Aspirate Concentrate/Stem Cell intervention process for osteoarthritis.
The safety and efficacy of pulsed electrical stimulation for treatment of osteoarthritis has been tested and confirmed. As well, the improvements in clinical measures for pain and function by Pulsed Electrical Stimulation have been documented. In a Regenerative Medicine conference I attended last year, challenge was put forth concerning modalities that might improve results of Bone Marrow Aspirate Concentrate/ Stem Cell intervention and act as a catalyst for post intervention cartilage regeneration. By chance, I was part of an investigational group on the treatment of osteoarthritis of the knee with pulsed electrical stimulation five years ago and I decided to review a potential role for post Stem Cell intervention with the pulsed brace. It took nine months but Friday came the preliminary approval and we will begin the trial in short order.
There are all kinds of unproven, anecdotal approaches in an attempt to restore cartilage in a degenerative arthritic setting but Pulsed Electrical Stimulation is the only methodology shown in the laboratory and in the clinical setting to have efficacy. At the same time in hundreds of patient studies, there have been no adverse effects. As we review the effect of Pulsed Electrical Stimulation on cartilage under a microscope, the device is safe with no adverse effect on cells. It makes sense; the adjunct is cost effective and just may help us do even better.
Tags: arthritis, athletes, Benefits and Risk, 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
