Sep 12, 2016
First of all, let me expand on the concept of Regenerative Medicine at times also understood as Cellular Orthopedics or Stem Cell therapy. Cells with stem cell properties are present in bone marrow, the peripheral circulatory system, adipose tissue, synovial tissue, muscle tissue, and tendon. At this time, the FDA allows point-of-care bone marrow aspirate intervention for arthritis. From a clinical standpoint, the stem cell concentrate of bone marrow aspirate is technique-dependent and I have found it to be an ever increasingly important factor of therapeutic benefit. When it comes to Adipose-Derived Stem cells, use of these products places risk upon the clinician and the patient because they do not meet the criteria of homologous use and are not autologous. Enter the latest interest in amniotic fluid concentrate with all the marketing hype. As of this time, to the best of my knowledge, there is no clinical outcomes science to justify such use. I should know as I am the Principal Investigator in the largest Clinical Trial involving amniotic fluid for arthritis ever undertaken.
Next, the reader should understand that Osteoarthritis is graded, not all OA is the same. To qualify for a Regenerative Medicine procedure, the degree of arthritis must not exceed grade three based on Imaging and Physical Examination. The standard grading system is termed the Kellgren-Lawrence Scale in which the X-ray image is scored. The physical examination is also taken into account to confirm that the extent of degenerative deformity has not exceeded inclusion criteria.
Now let me explain how Stem Cell intervention is accomplished in my setting, who may benefit, and when Regenerative Medicine is not a reasonable option. Actually if you watch my Webinar,
https://sheinkopmd.com/webinar/
you will better understand.
What are a patient’s options when a first intervention isn’t long lasting? Assume if you will that you have not realized the outcome that would be satisfying to you and rewarding to your interventional orthopedic specialist; there are two options:
Repeat Stem Cell Procedure
I have had at least ten patients in my practice who ultimately reached their goals after a repeat Bone marrow stem cell intervention
Joint Replacement
While it is a procedure that we seek to postpone, perhaps even avoid with a Regenerative Medicine intervention, stem cell procedures do not burn bridges
After watching my webinar, to learn more or schedule an appointment call 312 475 1893
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, treatment
Aug 12, 2016
“Whether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and osteoarthritis results in better functional outcomes than physical therapy alone is uncertain.”
The above article appeared in the May, 2013 edition of the New England Journal of Medicine but is still a subject matter of great debate in the orthopedic community. The major reason for the continued debate has to do with arthritis and the nature of the meniscal tear. In the study cited, 351 symptomatic patients 45 years or older with a meniscal tear and evidence of mild to moderate osteoarthritis were followed for up to 12 months using the same outcomes measurement modalities that I use in my Regenerative Medicine practice. The end result indicated no difference in outcomes for those who underwent arthroscopy and physical therapy as compared to those who underwent physical therapy alone.
In analyzing the study, there is no emphasis placed on the nature of the clinical tear or whether the osteoarthritis affects the entire joint or only a single compartment. What allows me to opine on the subject is my 40-year experience in treating the same type of patients prior to my having graduated to Cellular Orthopedics. During my surgical career, I used arthroscopic surgery when indicated and joint replacement, both total and partial when the latter were deemed appropriate. Now I use stem cells derived from bone marrow in almost every setting as there is evidence that the regenerative potential inherent in bone marrow concentrate will significantly impact the outcomes of patients with a degenerative meniscal tear with associated degenerative arthritis.
Be aware that the vast majority of patients over age 45 will show meniscal changes on an MRI. Also be aware that the vast majority of those meniscal changes will be accompanied by arthritic changes in the articular cartilage of the knee. The only absolute indication for arthroscopic intervention is the mechanical symptom such as “clunking”, locking or giving way. Otherwise, it is the judgement of the orthopedic surgeon that will lead to the definitive recommendation. Therein is the problem as the reconstructive orthopedic surgeon will tend to make one type of recommendation while the sports medicine oriented arthroscopist will tend to be surgically oriented.
If any cohort of patients with osteoarthritis and a degenerative meniscal tear is followed for five to ten years, progressive arthritic changes will be documented via a history and physical as well as via imaging studies. There is only one way to date to potentially alter this natural history and that is by intervening with stem cells and putting their regenerative potential into effect. If not addressed early on, those knee joint changes will result in an eventual grade four osteoarthritic degeneration and an indication for a knee replacement be it partial or total.
To learn more, come in for a consultation 312 475 1893
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, joint replacement, Knee, Knee Pain Relief, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
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
