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 28, 2016
Cartilage damage may result from trauma, repetitive motion/impact, abrupt abnormal weight bearing, fractures, wear/degeneration, joint infection, meniscectomy, friction/abrasion due to abnormal joint alignment, inflammatory diseases or a genetic predisposition to name a few reasons. The primary symptoms are pain, loss of motion and functional impairment.
As a form of connective tissue that is very primitive from an evolutionary standpoint, cartilage does not lend itself to intrinsic repair. All the attributes required for healing, while present in bone, are missing in cartilage including blood vessel supply, pain fibers, regenerative cells, fluid balance, and a rich source of nutrition. The cartilage in your joint is not populated by metabolically active cells nor is the chondrocyte capable of positively influencing its own environment. In keeping with all of the principal shortcomings of cartilage, chondrocytes do not replicate after age 40 and cannot migrate.
Because articular cartilage damage from any of the aforementioned causes is permanent and progressive, it is paramount that intervention takes place early in the degenerative process or soon after injury. The likelihood of a successful, enduring repair or restoration diminishes as generalized cartilage deterioration progresses.
There are many palliative interventions available such as weight loss, non-steroidal anti-inflammatory medication, shoe wedges, off-loader braces, cortisone injections, gels/visco-supplementation, and most recently, amniotic fluid concentrates. Missing though from all of these options is the regenerative potential. Bone Marrow Aspirate Concentrate not only introduces regenerative potential via adult mesenchymal stem cells, it is a huge resource for anti-inflammatory molecules termed cytokines. Equally important though are the extracellular vesicles (exosomes) termed growth factors. What about adipose derived stem cells and cultured stem cells?
While adipose tissue contains stem cells, the latter are not available unless liberated from their surroundings. An enzyme, collagenase has been the necessary ingredient but the use of collagenase is interpreted as tissue manipulation and thus not allowed by the FDA. While there was an introduction last July of a mechanical means of liberating stem cells from fat graft harvest, there are no outcomes as of yet to support said alternative. At the same time, while adipose derived stem cells have been used outside of the US, there are no studies indicating better outcomes with adipose derived cells as compared to bone marrow derived stem cells. The remaining question at this time is whether the results of cultured stem cells are superior to Regenexx SD outcomes. While there is anecdote, we have no Evidence Based Information to help guide Clinical Appropriate Use Criteria.
With all the above written, I am done for today; if you are still unclear or uncertain, call the office for an appointment.
847 390 7666
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Mar 21, 2016
Physicians should be in a constant state of education to keep their skills and knowledge at the forefront so that their patients get the best care possible. At the same time, I personally have devoted over 40 years to integrating patient care with research and education be it directed to joint replacement, and for the past four years, to postponing and at times, avoiding joint replacement. As the vast majority of health professionals, I strive on a daily basis to meet the need of my patients. Each and every patient for whom I provide care is entered into a HIPAA compliant outcomes database. From time to time, results are extracted from that data-base and presented at Cellular Orthopedic meetings. Soon we will be submitting the outcomes of several clinical trials for statistical analysis and publication. Almost every therapeutic intervention I recommend is based on science and statistically significant outcomes; rarely on anecdote.
The emerging field of regenerative medicine aims to deal with arthritis and cartilage injury by providing the required elements (cells, inductive molecules, and local environment) to promote true joint and cartilage regeneration. Cellular Regenerative Medicine is rapidly evolving and changing on an almost weekly basis. This is both good news and bad news as there are those who would try to prosper through marketing rather than science. Witness the invitation I received last week to travel to the Bahamas for stem cell care based on anecdote; or the advertisement for the “opportunity” to attend a weekend course to teach me how to use adipose tissue for every malady in the human body. How is it possible to track outcomes from medical tourism or to teach adipose related cellular orthopedic intervention when the latter is not FDA approved?
To assure you that I remain in the forefront of Cellular Orthopedics, from March 31-April 2, 2016, I will be participating in a Continuing Educational course, Articular Cartilage Restoration: The Modern Frontier, sponsored by the American Academy of Orthopedic Surgeons. This is a premier skills course that provides hands-on exposure and practice for the most updated techniques in cartilage restoration while allowing for a contemporary overview of established and new procedures to treat the entire knee joint for cartilage damage ranging from focal defects to arthritis.
Although I no longer am involved with orthopedic resident education, as Professor Emeritus at Rush, I have taken the Interventional Orthopedics Foundation pledge to continue to integrate my clinical interventions with outcomes surveillance. Several scientific presentations at the early March meeting of the American Academy of Orthopedic Surgeons resulted because of my ongoing initiatives. I am the orthopedic surgeon who four years ago, exchanged a scalpel for a stem cell.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Hip, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
