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
Jun 30, 2016
Out is routine Medicare and insurance coverage indemnification of hyaluronic acid injections for osteoarthritic joints other than the knee. Additionally, several insurance carriers are now requiring pre-certification to determine if they will even cover hyaluronic acid injections of the knee. The phenomenon was first reported in Florida but now the reduction in coverage is spreading across the country including Illinois. A physician may decide to proceed with the single, thee part or at times five part injection series but it would be at the expense of the patient if insurance and Medicare deny coverage. The reason behind the decision has to do with long-term studies that fail to validate the claims of the many advertisements you may see on television or find in the newspaper concerning the various forms of hyaluronic acid as a gel.
Increasingly in is Amniotic Fluid Concentrate for Osteoarthritis even though not covered by Medicare or Insurance. The clinical trial regarding outcomes for said therapy are incomplete; and to the best of my knowledge, the only source of Amniotic Fluid Concentrate providers seriously investigating results is MiMedx, out of Marietta, Georgia. Nevertheless, there seems to be an ever-increasing presence of Amniotic Fluid Concentrate offerings in the medical marketplace; unfortunately with unsupported claims of a stem cell content. There does seem to be a benefit from amniotic fluid concentrate in relieving the symptoms of an osteoarthritic joint but we have to wait for completion of current clinical trials to understand proper dosage and the length of action.
If you are a regular reader of this Blog, you will have become familiar with the term Subchondroplasty, an adjunct that I have been offering on occasion in conjunction with Bone Marrow Concentrate/Stem cell procedures into the joint. The successes of Subchondroplasty are such that the attention to the bone supporting the joint when working inside the joint is a subject gaining increased attention on a national basis. It looks like the future will be an increasing combination of both intra-articular and extra-articular intervention. While no one is able to confirm why the decompression of the bone adjacent to a joint relieves pain and why the adjunct of biologics improves longer-term outcomes, attention to bone defects in the area around the joint is proving to make a major difference in outcomes for arthritis. The question now is whether the best approach is Bone Marrow Concentrate inside and outside the joint or Bone Marrow Concentrate inside the joint with a synthetic augment outside the joint?
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx-SD, stem cells, Subchondroplasty, treatment
Jun 20, 2016
This past Thursday, I was reading the Steve Chapman article in the Chicago Tribune and in the article, he quoted French Sociologist Gustav Le Bon who is best known for his 1895 work The Crowd: A Study of the Popular Mind. While Chapman was trying to explain the Trump phenomenon, I saw an explanation as to why patients with arthritis make decisions as to how to proceed with care. At the recent Orthopedic and Biological Institute meeting in Las Vegas, speaker after speaker including napropaths, chiropractors, and non-board certified physicians presented a show and tell as to how they approach arthritis in this day of expanded access to orthobiologics. The explanations given approached the realm of fantasy; missing from the several day event were science, outcomes and results.
In the past several months, I have watched the entry of large orthopedic companies, with whom I have had a 40-year plus joint reconstruction relationships, into the growing specialty of Orthobiologics. These companies not only bring research support into our specialty of cellular (interventional) orthopedics, they carefully scrutinize those with whom they partner so the net result is evidence based patient care, research and education; not unfounded claims by “Camp Followers”. Witness the ad in a suburban newspaper placed by chiropractors offering stem cell containing amniotic fluid for the treatment of arthritis. I have written about this scientifically unfounded claim in this Blog before and I will emphasize it again, there are no living stem cells in amniotic fluid after processing, irradiating and fast thawing.
Assume if you would that you have an arthritic joint wherein your symptoms and limitations are no longer responsive to cortisone injections, anti-inflammatory medications, physical therapy, hyaluronic acid injections and the like. Your choices historically have been to either wait until end stage arthritis and then have a joint replacement or have a joint replacement early on and risk the potential adverse life changing consequences versus the potential benefits. Today there is an alternative option that will help postpone a joint replacement or possible help avoid one; it falls within the emerging discipline of Regenerative Medicine. Warning though, don’t be a victim of illusion; seek out a consultation and opinion from a board certified specialist who integrates cellular orthopedic patient care with research and education.
Call (312) 475-1893 to schedule your Orthobiologic consultation.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, Knee Pain Relief, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Regenerative, stem cells, technology, treatment
Jun 8, 2016
In the late summer of 2015, I was featured on a Fox cable news segment featuring a patient on whom I had performed a Bone Marrow Aspirate Concentrate –Stem Cell intervention coupled with a subchondroplasty procedure. The patient had experienced a poor result from a right Total Knee Replacement years earlier and was seeking a means of improving function and minimizing her left knee pain resulting from arthritis. Cartilage does not have a nerve supply so scientists and clinicians have long sought a clear understanding of the pain generator in osteoarthritis. While there still is not a clear-cut consensus, many clinicians are looking at the bone marrow lesions seen on an MRI when taken of an arthritic joint as the possible cause of pain associated with arthritis.
In the case of my patient, the combined BMAC-Stem Cell procedure coupled with the subchondroplasty had resulted in a very satisfactory outcome and such maintains at this time to the best of my knowledge. What was unique about my patient was the use of Bone Marrow Concentrate-Stem Cells to serve as the catalyst to effect healing of the bone marrow lesions. Up until that time, surgeons were using a synthetic calcium phosphate material to fill the defects above and below a joint surface with a mandatory three months of protected weight bearing and six months of altered physical activity. The introduction of Bone Marrow Concentrate with Stem cells required 48 hours of crutch support and six weeks of restricted physical activity.
My patient who received media attention served to foster a debate in the medical device industry as to the superior methodology serving as an adjunct to a subchondroplasty. First came the initial trial using a subchondroplasty procedure and synthetic filler with the inherent need for prolonged altered function and assisted ambulation. Now there are several clinical trials in development pertaining to an arthritic joint and the minimally invasive, percutaneous subchondroplasty comparing the synthetic filler to the Bone Marrow Aspirate Concentrate-stem cell adjunct; with the latter used both inside the joint and in the adjacent subchondral bone.
Are your arthritic joint changes affecting both the cartilage and the supporting bone? Is the actual source of your joint pain, the supporting bone or bone marrow lesions adjacent to the hip, knee, ankle or shoulder? It would require a complete examination and review of X-rays and an MRI for me to answer the question and advance the most appropriate therapeutic recommendation. Could it be that the failure of a regenerative intervention wasn’t a failure of the stem cells but rather a failure to address the real pain generator, subchondral bone?
Call for an assessment 312 475 1893 and I will try to answer that question.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, Subchondroplasty, treatment, Ultrasound Guided Injection
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
Oct 1, 2015
As I have previously indicated in my Blog, the world of Cellular Orthopedics is growing at an exponential pace. Evidence Based Medicine supports weight reduction, physical therapy, anti-inflammatories, analgesics, and cortisone injections for symptomatic relief. Evidence Based Medicine no longer supports the use of Hyaluronic Acid injections (visco-supplementation). Historically, the next step is a joint replacement when the aforementioned conservative measures no longer have an effect. When I initiated my practice of Interventional Orthopedics as part of the Regenexx Network, their patient satisfaction surveys supported the use of Bone Marrow Aspirate Concentrate interventions for osteoarthritic joints. Since my entry into the sub-discipline of Regenerative Medicine, we have gathered data on every patient seeking consultation and care and, have expanded the Outcomes measurement intake to include objective data points in addition to those of a subjective nature. Along the way, we have gained a better understanding as to how a patient might better respond to Interventional orthopedic options. The evidence is growing.
Just as my practice has grown and the Regenexx Outcomes Data base has grown, so too have the Interventional Orthopedic treatment alternatives increased. Now there is Amniotic Fluid Concentrates available to replace Hyaluronic Acid as a six to 12 month anti-inflammatory. As of July of this year, two companies have introduced Adipose derived stem cell alternatives claiming a mechanical means of emulsifying fat and eliminating the need for the enzyme collagenase; the latter not approved by the FDA when it comes to the musculoskeletal system. As of this time, there is no scientific evidence to support the claims of success in arthritis with both Amniotic Fluid Concentrate and Adipose Derived Stem Cells. Those studies will take several years before there is clinical evidence to support said use in arthritis.
What we have learned and is supported by clinical evidence is how to better plan and prepare for a Bone Marrow Aspirate Concentrate intervention. First a clinician must rule out referral of pain from other sources; this is accomplished by a thorough history and physical examination. The status of a meniscus, labrum, and the articular cartilage must be taken into account. Mechanical malalignment –a bowed leg or knock knee-must be ascertained and excesses corrected. Ligamentous deficiencies will contribute to the end result and must be corrected before any Intervention of an orthopedic nature.
I have provided a lot for a reader to digest. If you want clarification or to learn if you are a candidate for INTERVENTIONAL ORTHOPEDIC to postpone or eliminate a joint replacement for osteoarthritis, call for an appointment:.
847 390 7666
Tags: Amniotic, arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment
