Nov 1, 2016
The FDA again held a meeting to address issues pertaining to Regenerative Medicine. At the conclusion of the meeting, an updated set of guidelines was developed for patient protection in the use of stem cells, growth factors, and platelet rich plasma. While still being interpreted by the Regenerative Medicine community, what becomes clear is the call for better self-regulation. It is not ethical or acceptable for anyone holding themselves out to be practicing cellular medicine to hold a seminar, recruit a patient, inject some substance into a joint and request payment. Equally important are the credentials of that practitioner.
For the past four and a half years, I have followed the outcomes of all my patients using the same subjective and objective parameters in my practice of Interventional Orthopedics that I used to follow the results during my joint replacement career. Over that 37-year span, because of my data collection initiative, many new generations of Hip and Knee Prostheses were introduced into adult reconstructive orthopedic surgery. Statistical analysis of data allows for progress in care and development of new product. Today, I still gather outcomes data for each patient. That initiative has led to refinement and advances in the emerging subspecialty of Regenerative Medicine; both in my own practice and around the globe.
Anticipating the future, I am headed off this upcoming weekend to join a small group of those looking to the future in advancing the practice of cellular medicine. Up until now, our data collection and Outcomes registry was clinical in nature; in a short time, that data will also include cellular data. This latter is the next way to refine the practice of regenerative medicine.
By having tighter control over the composition of autologous PRP and BMC preparations for use in my practice of regenerative medicine, through comprehensive analysis of autologous patient samples, I will have a chance to see what levels of important constituents like Stem Cells, Growth Factors, Platelets, RBCs, WBCs, and so on are present in the preparation.
How might I take advantage of the data? The most obvious use would be for me to record values of your sample analysis in a spreadsheet and enter in demographic and clinical outcomes data. I will continue to enter your results of outcomes assessments obtained during follow-up visits that I routinely use to monitor your recovery. By applying this strategy to all patients I treat, an internal database will inform me about optimization strategies for treating my patients, allowing me to modify and customize the make-up of that which will be injected. Why go to the trouble, you might be asking yourself? Having a detailed knowledge of what I am injecting into my patient puts me in a position to refine my practice of regenerative medicine. And that is a good thing, since you the patient ultimately will benefit from my optimizing the use of autologous materials like PRP and BMC.
To schedule your appointment call 312 475 1893
Tags: arthritis, BMC, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, knee replacement, Osteoarthritis, Pain Management, Platelet Rich Plasma, platelets, PRP, regenerative medicine, stem cells, Ultrasound Guided Injection
Oct 27, 2016
I recently received the yearly publication from the Orthopedic and Rheumatology Institute of the Cleveland Clinic; the latter recognized as one of the 10 most prestigious orthopedic centers in the nation. Every year the publication, a marketing exercise by the Cleveland Clinic, focuses on certain subspecialty areas within the discipline of the care and treatment of the musculoskeletal system. The obvious purpose of such a yearly event is to recruit referrals from practicing orthopedic surgeons and rheumatologists as well as the medical community in general.
This year the focus was on Adult Total Hip Arthroplasty for Osteoarthritis and Adult Unilateral Total Knee Arthroplasty for Osteoarthritis. I will summarize the results; let’s start with the hip:
“Hip-Related Pain 1 Year After Surgery: “on average, 92% of patients reported clinically important improvement in hip-related pain after 1 year, while 1% reported worsening (7% showed no detectable change in hip-related pain).”
“On average, 90% of patients reported a clinically important improvement in hip-related function after 1 year, while 1% reported worsening (9% showed no detectable change in hip-related function).”
The knee doesn’t fare as well:
“On average, 85% of patients reported a clinically important improvement in knee-related pain after 1 year, while 2% reported worsening (13% showed no detectable change in knee-related pain).”
“On average, 82% of patients reported a clinically important improvement in knee-related function after 1 year, while 2% reported worsening (16% showed no detectable change in knee-related function).”
The data was derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed.
In my practice, every patient who undergoes a Bone Marrow Concentrate intervention is entered into an outcomes data base with both subjective and objective data points measured. It is quite comprehensive and numbers over 500 patients extending over a span now of 4 and ½ years. While the Cleveland Clinic report is based on subjective parameters and ours on both subjective and objective scores, I am able to extract subjective measures alone. I am pleased to report that in the case of the hip and the knee, our outcomes with a needle are equal to or better than those of the major surgery with a scalpel. Then factor in the prompt rehabilitation of a stem cell procedure compared with the prolonged rehabilitation inherent in a joint replacement. Lastly, consider the relative absence of complications of a stem cell intervention compared to the morbidity and mortality of a joint replacement.
Perhaps of greater significance to the stated advantage of a Bone Marrow Concentrate procedure for Osteoarthritis is the fact that no bridges are burned. If the patient is not satisfied at one year or five, a stem cell procedure may be repeated with a needle. If the arthritis progresses to an advanced stage, the fall back option is a joint replacement. The only choice following an unsatisfactory joint replacement is to accept the surgically induced impairment or undergo a risky revision surgery with a high likelihood of a complication or less than satisfactory outcome. Call 312 475 1893 to schedule an appointment today.
For more information watch my Regenerative Medicine Webinar Video
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, knee replacement, Orthopedic Care, Orthopedics
Oct 15, 2016
Background: It is increasingly recognized that biochemical abnormalities of the joint precede radiographic abnormalities of post traumatic osteoarthritis (PTOA) by as much as decades. A growing body of evidence strongly suggests that the progression from anterior cruciate ligament (ACL) injury to PTOA is multifactorial, involving the interplay between biomechanical disturbances and biochemical homeostasis of articular cartilage.
Purpose: A randomized study using an acute ACL injury model were to (1) evaluate the natural progression of inflammatory and chondro-degenerative biomarkers, (2) evaluate the relationship between subjective reports of pain and inflammatory and chondro-degenerative biomarkers, and (3) determine if post injury knee drainage (arthrocentesis) and corticosteroid injection offer the ability to alter this biochemical cascade.
Study Design: Randomized controlled trial.
Methods: A total of 49 patients were randomized to 4 groups: group 1 (corticosteroid at 4 days after ACL injury, placebo injection of saline at 2 weeks), group 2 (placebo at 4 days after ACL injury, corticosteroid at 2 weeks), group 3 (corticosteroid at both time intervals), or a placebo group (saline injections at both time intervals). Patient-reported outcome measures and synovial biomarkers were collected at approximately 4 days, 11 days, and 5 weeks after injury. The change between the time points was assessed for all variables using statistical analysis, and the relationship between changes in outcome scores and biomarkers were assessed by calculating a commonly accepted mathematical analysis. Outcomes and biomarkers were also compared between the 4 groups using another statistical approach.
Results: No adverse events or infections were observed in any study patients. With the exception of matrix metalloproteinase 1 (MMP-1) and tumor necrosis factor–inducible gene 6 (TSG-6), chondro-degenerative markers worsened over the first 5 weeks while all patient-reported outcomes improved during this time, regardless of treatment group. Patient-reported outcomes did not differ between patients receiving corticosteroid injections and the placebo group. However, increases in C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, were significantly greater in the placebo group (1.32 ± 1.10 ng/mL) than in either of the groups that received the corticosteroid injection within the first several days after injury (group 1: 0.23 ± 0.27 ng/mL [P = .01]; group 3: 0.19 ± 0.34 ng/mL [P= .01]).
Conclusion: Post Traumatic Osteoarthritis begins at the time of injury and results early on in dramatic matrix changes in the knee. However, it is encouraging that early intervention with an anti-inflammatory agent was able to affect biomarkers of chondral degeneration. Should early intervention lead to meaningful changes in either the onset or severity of symptomatic PTOA, the current treatment paradigm for patients with ACL injury may have to be restructured to include early aspiration and intra-articular intervention.
This Blog is excerpted from a study appearing in the American Journal of Sports Medicine. My message, should you experience a significant joint injury, don’t wait until arthritic related symptoms appear, the Cellular Orthopedic intervention should take place within weeks; not years.
312-475-4523 to learn more or schedule an appointment
Tags: ACL Injury, ACL tear, arthritis, athletes, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, corticosteriod injection, Interventional Orthopedics, Knee, knee injury, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon
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
Sep 1, 2016
You may be the first to see the preview
A web-i-nar according to the dictionary, is a seminar that takes place over the internet.
Dr. Sheinkop’s Webinar on Regenerative Medicine
While not yet ready for prime time, it will go live in 45 days, but readers of this Blog may view it now by clicking the above. My purpose in creating this educational endeavor is and was to better inform the prospective patient as to the scope of my regenerative practice, to allow the new patient to become better informed, and to facilitate review of the informed consent process should you chose to avail yourself of my services. The webinar plays for about 30 minutes but you don’t have to watch it all in a single session. One of the advantages of this form of communication is watching at your own convenience plus the option to return as you chose.
In planning and editing this undertaking, I took into account that which I have experienced over a four year plus regenerative medicine practice emphasizing and repeating wherever I deemed appropriate. The majority of the patients I treat present with grades two and three osteoarthritis of one or two joints. Of over a thousand I have treated, the majority have received Bone Marrow Concentrate/Stem Cell approach. For those who present in an earlier stage of osteoarthritis no longer responding to cortisone and hyaluronic acid, I do explain the Multicenter Amniotic Fluid Concentrate Clinical Trial for which I am the Principal Investigator. By the same token, for those patients who have advanced arthritic changes, that is grade four, and who otherwise would require a total joint replacement, I cover cellular orthopedic options as well although not necessarily bone marrow derived. One major possibility in the webinar format once accessed through the internet will be the opportunity to post questions and I will do my best to respond in 24 to 48 hours. Another area of explanation is the subchondroplasty for which there continues to be increasing evidence that both intraarticular (inside the joint) and extra-articular (the bone supporting the joint) options should be employed when treating arthritis of a major joint. I want to emphasize, the main treatment on which I base my practice is Bone Marrow Concentrate containing stem cells, anti-inflammatory Cytokines and Growth Factors owing to the potential to regenerate the joint, eliminate or reduce pain and increase functional capacity while, on a molecular basis, halting, maybe reversing the arthritic process.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx-SD, stem cells, treatment
