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
Apr 18, 2016
Articulate cartilage has little to no capacity to undergo spontaneous repair because it has no blood supply nor is it able to regenerate across a physical gap. In order to restore cartilage in a skeletally mature patient, there is a need for outside help. In some settings, osteochondral transfer (bone with cartilage) may be harvested from elsewhere in a damaged joint and repositioned or relocated in that joint. In other settings, fresh cadaveric tissue (allograft) may be used. More recently, attempts have been directed at “engineering” cartilage. For engineering to take place, there are three requirements. First must come a matrix scaffold necessary to support tissue formation. Second are cells such as mesenchymal stem cells either from bone marrow or synovial membrane lining the joint. Third comes signaling molecules (cytokines) and growth factors. Platelet Rich Plasma is a source of signaling molecules. While Bone Marrow Concentrate doesn’t meet every need for tissue engineering, to the best of my knowledge at this time, there is nothing superior for a long term successful outcome either as an adjunct to a surgical procedure for a small defect or as a primary intervention for an arthritic joint.
There are several ways to measure success after an attempt at cartilage repair. For a contained or global defect, MRI is the primary outcome measure; whereas for osteoarthritis, the Outcome objective metrics I use have proven statistically significant and reproducible. I write this Blog in between presentations by the faculty at American Academy of Orthopedic Surgery Program: Articular Cartilage Restoration-The Modern Frontier. I came here to learn and learn I did about surgical procedures for contained injury. When it comes to osteoarthritis, I learned little but contributed much. No, I am not being egotistical, I am reporting what transpired at the meeting and what is transpiring in my practice. Of interest is the universal agreement by those treating the global defect with surgery and those of us who treat osteoarthritis with stem cells; including the supporting bone ( bone marrow edema)in the therapeutic algorithm via subchodndroplasty is paramount.
“He, who has data, need not shout”
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, Regenerative, Regenexx, stem cells, treatment
Apr 4, 2016
Patients should participate in strengthening, low-impact aerobic exercises, and neuromuscular education; and engage in physical activity.
Rationale:
This recommendation is rated strong because of seven high-strength studies of which five showed beneficial outcomes. The exercise interventions were predominantly conducted under supervision, most often by a physical therapist.
I recommend weight loss for patients with symptomatic osteoarthritis of the knee and a BMI = 25.
Rationale:
Physical Function shows important improvement in outcomes for this patient population. Function also shows statistical improvement that is clinically significant. Diet and exercise combined achieves the best results.
I do not recommend using acupuncture in patients with symptomatic osteoarthritis of the knee
Rationale:
In Studies that comparing acupuncture to groups receiving non-intervention sham, usual care, or education, the majority, show no clinically significant improvement. While there is a lack of efficacy, there is no potential harm.
I am unable to recommend for or against the use of physical agents (including electrotherapeutic modalities) in patients with symptomatic osteoarthritis of the knee.
Rationale:
Due to the overall scientifically inconsistent findings for various physical agents and electrotherapeutic modalities, I am unable to make a recommendation for or against their use in patients with symptomatic osteoarthritis of the knee. To better understand the role of pulses in the management of arthritis, I am waiting for FDA approval to launch a clinical trial using a pulsed brace after a bone marrow concentrate/stem cell procedure.
I am unable to recommend for or against manual therapy in patients with symptomatic osteoarthritis of the knee.
Rationale:
Due to the lack of studies examining most manual therapy techniques, I am unable to opine. No studies evaluating joint mobilization, joint manipulation, chiropractic therapy, patellar mobilization, or myofascial release were found of scientific merit.
I cannot recommend using glucosamine and chondroitin for patients based on science; yet I personally use them
Rationale:
At this time, both glucosamine and chondroitin sulfate have been extensively studied. There is essentially no evidence that minimum clinically important outcomes have been achieved compared to placebo. There is no evidence of potential harm. The same may be said of the neutraceuticals methylsulfonylmethane, omega-3, gelatin, vitamin D, dimethylsulfoxide, antioxidants, and coenzyme Q10. 01
I will not use needle lavage for patients with symptomatic osteoarthritis of the knee.
Rationale:
The published evidence shows little or no benefit from needle lavage in the treatment of osteoarthritis of the knee.
I am able to recommend growth factors and stem cells derived from Bone Marrow Aspirate in conjunction with platelet rich plasma for patients with symptomatic osteoarthritis of the knee.
Rationale:
I have an ever-increasing Data-Base of Outcome measurements to support my recommendations with Levels of Evidence at 1B and 3 with a Grade D governmental guideline Grading (the highest). You may learn more at the National Guideline Clearinghouse (http://www.guidelines.gov) or make an appointment at 847 390 7666
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Mar 17, 2016
In a commercial advertisement appearing on page 3 of the Monday, March 14, 2016 Chicago Tribune, a claim by the Osteo Relief Institute bases, in part, the validity of a “cutting-edge” treatment-Viscosupplementation intervention-on an article published in the Journal of Managed Care Pharmacy. Having published over 100 scientific papers in peer reviewed journals and never having heard of the Journal of Managed Care Pharmacy; I looked up the Journal to learn it is an advertising vehicle for the pharmaceutical industry.
From the American Academy of Orthopedic Surgeons: “AAOS Evidence-Based Clinical Practice Guidelines are based on a systematic literature review of published studies. Multidisciplinary guideline development groups construct Evidence-Based Clinical recommendations.” “Although some patients report relief of arthritis symptoms with viscosupplementation, the procedure has never been shown to reverse the arthritic process or re-grow cartilage”. The AAOS no longer supports the use of Viscosupplementation in the treatment of arthritis.
What we do with your stem cells at Regenexx is not only address symptoms of arthritis; based on our clinical trials, data base, and scientific publication documentation, is to improve function while addressing the progression of arthritis at a molecular and bio-immune level. Stem cells, in addition to the cytokines and growth factors in Bone Marrow Concentrate, have the potential to regenerate cartilage. Because of the lack of proven success over 20 years as determined by meta-analysis of the scientific literature concerning viscosupplemenation, the Regenexx network is moving away from offering Hyaluronic acid (Gels) and slowly the insurance industry is dropping coverage as well.
There is no question that the Osteo Relief Institute marketing campaign is attractive to a patient but what about a scientific foundation? Don’t get me wrong, I too can succumb to well done advertising. The Most Interesting Man in the World ad campaign caused me to switch to Dos Equis beer. Your arthritic related limitation is a totally different matter and your choice of treatment should not be influenced by an advertising campaign. Seek out that which is evidence based and available through board certified physicians and surgeons.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
