Aug 4, 2016
There are now available six month follow up Outcomes Data regarding 20 patients who underwent a fat graft harvest, micro-fracture of the fat graft and intervention in an arthritic knee, the latter so severe that the original recommendation to the patient had been a Total Knee Replacement. 85% of this group are very satisfied at this time with the post intervention pain relief and functional improvement. One patient did elect to undergo a Total Knee Replacement eight weeks after the initial intervention. While six-month Data is very preliminary and doesn’t lend itself to a scientific journal publication, I am told the results will become the subject matter of a White Paper, an authoritative report, while the outcomes of the 20 patients will continue to be monitored.
As I have previously reported, I personally am taking a Principal Investigator role in a Clinical Trial centered on the most contemporary ortho-biologic methodology for processing Amniotic Fluid Concentrate. What piqued my interest is the continued marketing placements in our media: ”Stem Cell therapy is an exciting new therapy option that treats arthritis”. “Free Educational Seminar”. “Stem cell regeneration utilizes amniotic stem cells”. I am reminded of the prank I used as a child on my playmates “Pete and Repeat were sitting in a boat, Pete fell out, who was left?” As I have written on my Blog multiple times, there are no viable stem cells in amniotic fluid once processed, irradiated, frozen and fast thawed. That is not to say that AFC may not act as an anti-inflammatory eventually replacing visco-supplementation in attempting to improve the well-being of patients affected by arthritis; but it has no regenerative potential. My interest in leading a Multi-Center Clinical Trial -no out of pocket expense for those who meet the inclusion criteria-is to learn appropriate dosage and duration of effect if any. Subchondroplasty continues to be a subject of increasing interest in the orthobiologic world. I will be serving as a Principal Investigator in a stem cell based subchondroplasty clinical trial as soon as there is IRB approval toward the end of August. I hope to determine if a combined intraarticular and extra-articular Bone Marrow Concentrate approach will result in superior outcomes when contrasted to the standard intraarticular approach.
Be advised and reminded the Regenerative Medicine discipline is evolving and the over seer is the FDA. Make sure that should you decide to pay unreasonable amounts for unproven therapies, those marketing such are doing so under an IRB regulatory methodology. To learn more, schedule an appointment:
312 475 1893
Tags: Amniotic, arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment
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 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
