Feb 4, 2016
Description of Procedure or Service
Mesenchymal stem cells (MSCs) have the capability to orchestrate cell differentiate into a variety of tissue types, including various musculoskeletal tissues. Potential uses of MSCs for orthopedic applications include treatment of damaged bone, cartilage, ligaments, tendons and intervertebral discs. Stimulation of endogenous MSCs is the basis of procedures such as bone marrow stimulation (e.g., microfracture) and harvesting. Bone marrow aspirate is considered to be the most accessible source and thus the most common place to isolate MSCs for treatment of musculoskeletal disease. The U.S. Food and Drug Administration (FDA) has stated that cell-based therapies are one of the most rapidly advancing approaches intended to repair, replace, restore, or regenerate cells, tissues and organs
While concentrated autologous MSCs do not require approval by the U.S. Food and Drug Administration (FDA); Mesenchymal stem cell therapy is considered investigational for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue. Since as of this writing, the Corporate Insurance world does not cover investigational services or procedures, Cellular Orthopedic interventions are not indemnified. It is a self pay undertaking.
The use of mesenchymal stem cells (MSCs) for orthopedic conditions is an active area of research. Despite this research into the methods of treatment, there are uncertainties regarding the optimal source of cells and the delivery method. Current available evidence on procedures using autologous bone-marrow-derived mesenchymal stem cells (MSCs) for orthopedic indications in humans consists primarily of case series and small non-randomized comparative trials with insufficient data to evaluate health outcomes. In addition, expanded MSCs for orthopedic applications are not FDA approved (concentrated autologous MSCs do not require FDA approval). Due to the lack of evidence that clinical outcomes are improved and the lack of regulatory approval, use of stem cells for orthopedic applications is considered investigational.
The above is in part taken from information to be found by searching Corporate Medical Insurance Policy via the internet. As you are aware if you are a reader of this Blog or as you will become aware after reading this Blog, the members of the Regenexx Network are gathering outcomes data that could result in a future change of Corporate Indemnification Policy for Regenerative Medicine. Actually, a corporate policy review for BCBS is scheduled next month.
In the mean time, a mailing from the AARP last week put everything into perspective and it came as an offering from AARP-Advantages having to do with protection for your pet, Petplan. “Every six seconds a pet parent is faced with a vet bill for more than $3,000.” What follows are some of the costs associated with your pet, the cost of caring:
Ear Infection—– ————–$4,048
Hip Dysplasia——————-$9,808
Ingestion of foreign body—-$9,389
Periodontal disease————-$2,651
Motor vehicle accident——-$11,695
I think you get the message. It is my job to make sure you get as good care and as good an outcome as you seek for your pet and we certainly cost less. 847 390 7666 to schedule appointment
Tags: 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, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, treatment
Jan 25, 2016
Although Orthobiologics and Cellular Orthopedic interventions generally result in excellent pain relief and return to or maintenance of a high degree of function, approximately 20 percent of patients have persistent functional deficits that affect their quality of life as I have learned after review of three and a half years of Regenexx procedures for the hip and knee.
It looks as if lumbar spine problems are a common cause of functional disability in patients presenting with hip and knee arthritis. While, I didn’t perform a particular study, in reviewing those with less than optimal outcomes from my first three plus years of Regenerative Medical procedures, I observed that patients with a prior history of lumbar spine problems had significantly worse hip and knee functional scores when compared to the majority who did well and had no documentation of a preexisting spinal abnormality.
The results of my observations mirror multiple previous studies that have found poor pre operative and post operative knee and hip function in patients undergoing a joint replacement who had a spinal degenerative co-morbidity. Through the review of our data base, we have identified the problem. Now I must determine the alternatives in dealing with the problem. First of all, from here on out, all new and returning patients will be questioned about their back related symptoms; and when deemed appropriate, images will be requested. If a significant degenerative disc or joint process is identified then the patient will be appropriately advised and referred for timely intervention. As of this writing, the options are either classical pain management or surgical in nature. The good news is that included in classical pain management for the spine is a very successful approach focusing on weight reduction, Pilates core strengthening, and Tai Chi, yoga or stretching. The failure of these non operative approaches is based on the failure of a patient to commit three or four days a week. The next level of pain management is injection based. Historically, an epidural series has been the standard but more recently, Regenexx introduced PRP as a safer and longer lasting approach. As of this writing, Regenexx and others have introduced intradiscal procedures, but I want more outcomes before I recommend such.
As far as what I do for arthritis, there will be more attention to devoted to the patient’s back when we do the intake for an arthritic joint. On the other hand, we do have several improvements and additions in our ever evolving menu of services for the arthritis hip and knee. To learn more, schedule a consultation:
847 390 7666
Tags: arthritis, Benefits and Risk, Bone Marrow Concentrate, Hip, Hip Replacement, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, PRP, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Jan 11, 2016
The Regenerative Medicine Menu
- Hydrocortisone
- Hyaluronic Acid (HA)
- Platelet Rich Plasma (PRP)
- Amniotic Fluid Concentrate (AFC)
- Bone Marrow Aspirate Concentrate (BMAC)
- Regenexx-SD Procedure
- Simple Adipose Graft
- Stromal Vascular Fraction (SVF)
The human body posses a remarkable capacity to heal. Following tissue damage or disease, the body’s immune response coordinates a sequence of events to fight off harmful disease or infections and repair the damaged tissue. While scar tissue may form as a byproduct of rapid healing, scar tissue may be remodeled over time. This is the Normal Healing Response. The goal of regenerative therapies is to modulate these stages of healing be it soft tissue, cartilage or bone.
As a response to the delisting by the AAOS of Hyaluronic Acid from the osteoarthritis armamentarium, industry has attempted to fill the void with Amniotic Fluid Concentrate. For those unfamiliar, when a pregnant woman schedules a C-Section, she is approached about “donating” her amniotic fluid that may be recovered at the time of the procedure. During the course of the pregnancy, the potential donor is screened for communicable diseases. There is little if any immuno-rejection phenomenon and the AFC has growth factors, anti-inflammatory cytokines and Hyaluronic acid all in high concentration. While there are large numbers of stem cells deposited by the fetus and the placenta during the course of the pregnancy, by time the Amniotic Fluid is concentrated, processed, frozen for preservation and finally fast thawed for usage, little in the way of viable stem cells may be observed. Never the less, the AFC has great potential in the arthritic setting; and when micronized, is a marvelous adjunct in effecting wound healing for the diabetic and wound that won’t heal.
At our Regenerative Pain Center, we have observed over 40 different interpretations for the term PRP. The problem is that there is no standard of concentration, quality or quantity. To that end, an attempt is underway to reach accord on an actual standard definition. Then there comes the dilemma of whether the PRP is best when leukocyte free or not. Next comes the argument to support Platelet Poor Plasma (PPP). In our practice, we alter the formula according to the needs of the patient.
You will note at the get go, the repeat Bone Marrow Aspirate Concentrate bullets. There is bone marrow aspirate concentrate and then there is the Regenexx -SD approach. The latter is what has been so effective in our practice for three and a half years; so much so that it is what I truly believe in for moderate osteoarthritis and even advanced in certain settings.
While “simple” adipose grafts are heavily marketed, let me refer you to Pope Brock’s Charlatans, first published in 2008 to understand my view of how plastic surgeons are victimizing patients by including the management of arthritis in their cosmetic approaches. Last of all is the new introduction of the Stromal Vascular Fraction following the micro-fracture of fat graft. The latter became available in the US in mid summer, 2015. Clinical trials are in progress. If you want to delay or possibly avoid a joint replacement for arthritis, call for a consultation 847 390 7666
Tags: Amniotic, arthritis, athletes, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Hip, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, PRP, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Jan 7, 2016
The last Blog posted in 2015 indicated that I wouldn’t look back; but after its posting, I received this correction form Dr Chris Centeno, arguably, the best informed Regenerative Medicine expert in the North America.
“Mitch,
The discussion of amniotic injections isn’t correct. We found that amniotic tissue hurt stem cells. While we did find a weak growth factor/cytokine effect, it was less than PRP. So extrapolating that data, it would be stem cells>PRP>amniotic. Please correct.
Chris”
I very much appreciate his input as well as invite his ongoing constructive criticism, additions and recommended corrections. Let me add, the PRP he is referring to is not the usual and customary office based 15 minute procedure; but rather a proprietary process developed in the Regenexx laboratories and available from those physician members of the Regenexx network.
Changing my focus, in a review article appearing in the January 2016, volume of the Journal of the American Academy of Orthopedic Surgeons, an article appeared Risk Prediction Tools for Hip and Knee Arthroplasty. It is easier for me to quote rather than extrapolate: “After arthroplasty, complications such as infection, venous thromboembolism, acute myocardial infarction, pneumonia and many others are associated with poorer patient outcomes and represent a substantial cost burden to the American healthcare system”. The article continues: “Total joint arthroplasty is thus an appropriate target for quality improvement and cost containment via pay-for-performance initiatives.” For someone such as myself, an orthopedic surgeon who devoted a 37 year career after nine years of post graduate education and training performing Total Joint Replacements, I feel that my professional evolution into cellular orthopedics is again validated. In reviewing our data base, following a cellular orthopedic intervention for arthritis, we have not recorded one infection, venous thromboembolism, acute myocardial infarction, case of pneumonia, or any other complication. While 100% of my patients do not experience a successful or satisfactory outcome following the first cellular orthopedic intervention for arthritis, those numbers increase from 75% to 85% with a booster or repeat procedure. Once again, the end result of an unsuccessful Total Joint Replacement is a revision surgery; after a revision, it was not unusual to hear a patient volunteer “give me back my arthritis”. After a less than optimal outcome of a cellular orthopedic intervention, the fallback position is a repeat procedure followed by a patient’s “thank you doctor.”
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, C-SCP, Concentrated Stem Cell Plasma, Hip, 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
Dec 29, 2015
I won’t look back so let’s see what’s coming in 2016. The clinical Regenexx Knee Trial introduced in 2014 will start providing information here-to-for unavailable in Cellular Orthopedics. Many times in the last several years I had written about my observation that there is a paucity of science and a plethora of marketing without support in the world of Regenerative Medicine. Last week, a patient came to my office for a second opinion after having attended a seminar on amniotic fluid concentrate. The patient had carried away a notion that amniotic fluid concentrate contains viable stem cells that will regenerate an arthritic knee. Several months ago, I had reviewed the subject in my Blog after having attended the first Interventional Orthopedics Foundation meeting in Broomfield, Colorado. After extensive testing in a laboratory setting, it was documented that while there may have been stem cells in the amniotic fluid when recovered, by the time the material was processed, frozen, and fast-thawed, the amniotic fluid commercially available has no regenerative potential. The role of amniotic fluid concentrate in 2016 will be to replace visco-supplementation in the marketplace as more and more insurance carriers will withdraw coverage based on publications from the American Academy of Orthopedic Surgeons on the benefit or lack thereof from visco-supplementation. If there are no stem cells in the amniotic fluid concentrate, what is there that may be helpful? The scientific laboratory studies did confirm that the Growth Factors and anti-inflammatory cytokines do survive processing and may be of equal or even greater importance in the long run than the stem cells. My plan is to replace visco-supplementation with amniotic fluid by mid 2016 in my practice.
I want to return to our Regenexx Knee Clinical Trial. It is the largest of which I am aware in the world as far as the methods used in determining the success of a stem cell intervention for Grades Two and Three Osteoarthritis of the knee. I was chosen to execute this three to five year outcomes study because of my background as director of the joint replacement program at Rush, one of the five largest joint replacement programs in the country. In addition, over my 40-year joint replacement career, I had published many studies on the outcomes of a hip and knee replacement at five and ten years. Our preliminary observations concerning those who met the trial inclusion criteria are that the vast majority, are very satisfied and active. Certainly, we will have to wait another year before our numbers allow for statistical analysis; but so far, the outcomes are excellent. Please keep in mind the methodology for the intervention is not a single injection but rather a carefully designed treatment program. To learn more, call for a consultation
847 390 7666 with offices in Des Plaines and Lincoln Park
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Pilot Study, Regenexx, Regenexx-SD, stem cells, treatment
