Jul 22, 2016
As the regular readers of this Blog are aware, one way to catch my attention is to send me another announcement found in a local newspaper regarding “free” Amniotic Fluid Concentrate seminars in which the reader (victim) then learns at the seminar that he or she can receive stem cells to cure whatever ails that person for a fee ranging between $7,000 and $9,000.
Based on what is scientifically certain about Amniotic Fluid Concentrate, in spite of what you are told at these seminars by the marketing spokesperson, there are no viable stem cells once the amniotic fluid is processed, concentrated, gamma irradiated, and fast thawed for the injection. Nevertheless, the Camp Followers are saturating the media with claims of benefit for almost every malady known to mankind by paying this exorbitant sum for a single injection. That is not to say there is not anti-inflammatory benefit and growth factor content in amniotic fluid concentrate so there is some pain relieving potential. What is not known is the optimal dose schedule, dosage concentration, and the duration of benefit.
In order to scientifically determine how to properly use amniotic fluid concentrate in a clinical practice and statistically measure value, I have accepted the invitation from a major Ortho-biologic producer of amniotic fluid concentrate to participate in a multicenter Clinical Trial under FDA regulatory scrutiny. Our study group will determine the benefit of amniotic fluid concentrate in the arthritic knee, the proper dosage schedule, the appropriate concentration and the duration of effect.
For those who elect to partake in this Clinical Trial and who meet inclusion criteria, there is no charge for the pharmacologic agent (Amniotic Fluid Concentrate). On the contrary, the participant will be reimbursed for travel expenses. By helping us understand the benefit of Amniotic Fluid Concentrate (if any) when used for an arthritic knee and determining appropriate dosage scheduling, the Ortho-biologic industry and we clinicians will finally learn if it works; and if so, for how long and at what dosage. So you decide, either call the number appearing in the media ads and be ready to pay up to $9,000 for a stem cell intervention without living stem cells or call 312 475 1893 to learn if you meet the inclusion criteria for the Multicenter Trial.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, 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 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
