We now are approaching five-year outcomes regarding the use of Bone Marrow Concentrate for Osteoarthritis of the hip, knee, shoulder and ankle. Bone Marrow contains Adult Mesenchymal Stem (MSC) cells and Growth Factors. In the beginning, the entire informed consent process focused on the MSC in bone marrow as the agent responsible for diminishing pain, improving motion, stopping, at times reversing the progression of osteoarthritis, and potentially regenerating the joint itself. Now we know that equally important to the MSC are the growth factors produced and stored in the bone marrow. Some of the key proteins (Growth factors) include Interleukin-1 Receptor Antagonist Protein (IRAP), Alpha-2-Macroglobulin (A2M), fibrinogen, PDGF, VEGF, and TGF-B to name a few.
The reason we directed our clinical initiatives to Bone Marrow Concentrate is that while Amniotic Fluid contains Hyaluronic Acid, once harvested, sterilized and fast thawed for clinical application, there are no living stem cells left, so Amniotic Fluid Concentrate has no regenerative potential. When it comes to Adipose Derived Stem Cells, in order to liberate the stem cell from the adipocyte, an enzyme, collagenase must be employed. The latter is not approved by the FDA. Additionally, there is no evidence of Growth Factor content in adipose derived tissue.
While I have blogged about the superiority of Bone Marrow Concentrate over all other non-surgical approaches for arthritis, the introduction of the intraosseous adjunct, subchondroplasty, is resulting in even superior outcomes when compared to those who were treated prior to this contemporary version of Cellular Orthopedics. It has been nine months basically since I started injecting Bone Marrow Concentrate into the marrow adjacent to the joint in addition to the intraarticular approach. We already are seeing a better outcome in those who availed themselves of the Intraosseous adjunct. Up until eight weeks ago, my ability to offer contemporary and improved treatment options was limited by preexisting contractual obligations; but now unrestricted, I have expanded my scope of offerings including elevation of subchondroplasty from a clinical trial status to usual and customary adjunct standard of practice option. As well, I now offer an increased opportunity for participation in other clinical trials for the arthritic joint when a patient meets obligatory inclusion criteria determined by the trial sponsor.
If you want to postpone, perhaps avoid a major surgical replacement for an arthritic joint, call for a consultation 847 390 7666
You may visit my web site at IlCellulartherapy.com where you may watch my webinar.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Microfracture surgery, Orthopedics, Osteoarthritis, Pain Management, stem cells, treatment
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
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
Every week, I receive updates via brochures and journals concerning the clinical and basic science orthopedic research being done around the country at the various university medical centers. I like to read them to understand how Cellular Orthopedics is emerging and is being accepted in academic institutions. When I retired from Rush and joint replacement surgery five years ago, my colleagues had a very jaundiced view of my new endeavors telling me and then my patients that Regenerative Medicine was unproven, was ten years away, and was not a reasonable alternative to a joint replacement. It is with great pleasure that I am able to announce the American Academy of Orthopedic Surgery Surgical Skills update will include a three day course next month on Articular Cartilage Restoration: The Modern Frontier, as a continuing educational initiative. The title of one particular lecture really caught my attention Move-Over PRP/Viscosupplementation: Stem cells are in and why.
Taking it a step further, the latest bulletin from Jefferson Medical College’s department of orthopedic surgery reviews the basic science being done in the Laboratory of Theresa Freeman, PhD, Associate Professor of Orthopedic Surgery. “The development of Osteoarthritis can often be attributed to a trauma that occurs in youth, which begins the slow degeneration of cartilage. By reducing cartilage damage immediately after an injury, the development of osteoarthritis can be dramatically slowed.”
I have been making the case for an affirmative stem cell intervention every time an anterior cruciate surgical repair takes place or for that matter, when an individual undergoes an arthroscopic procedure. Two weeks ago, I completed a Bone Marrow Aspirate Concentrate Stem cell procedure three weeks after a young middle aged man had undergone micro fracture for a cartilage defect on the weight bearing part of his femur at the knee. On Friday, I scheduled a 72 year old gentleman for a stem cell procedure ten days after he had undergone arthroscopic surgery for a degenerative tear of his medial meniscus during the course of which degenerative changes were documented in the weight bearing zone at the inner compartment of his knee.
A webinar is scheduled by the American Academy of Orthopedic Surgeons next month in order to introduce its orthopedic membership to what may be possible through Cellular Orthopedics. I have already advised you about the Continuing Education Course next month on Articular Restoration. The orthopedic academy membership is only now being introduced to what I have been practicing for almost four years. There are now close to 750 patients in my data base who have undergone Cellular Orthopedic procedures for arthritic joints to relieve pain, increase function and avoid, certainly postpone a joint replacement. On Saturday, I am headed out to Colorado to ski with family for a week. For readers of my blog, you may recall I have undergone a regenerative procedure for my left knee. While I am realistic and I don’t dwell on being who I used to be, I believe anything is possible at any age. If you want to continue or possibly return to skiing, biking, hiking, climbing, fly fishing, skating, fitness, etc, and the limitation is arthritis, schedule a consultation
847 390 7666
Tags: ACL Injury, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenerative Pain Center, Regenexx, stem cells, treatment
In a more recent understanding of the arthritic joint, science now tells us that it is not only loss of cartilage that leads to pain, loss of motion, altered function and a progressive downhill course; but rather an involvement of the entire joint as well as the bone supporting the joint. The mechanism is probably bio-immune in nature and the reason for our success in treating the arthritic joint with orthobiologics is based on addressing molecular changes within the joint. The Europeans however have taught us that almost as important as intervention inside the joint is addressing the bone supporting the joint. In a recent scientific meeting, Spanish and French Orthopedic Surgeons demonstrated improved overall results within the arthritic joint by treating the changes outside of the joint as seen in an MRI. These changes are frequently described as bone contusions or bone marrow lesions. When followed, it becomes apparent that the altered bone fails to support or protect the cartilage within the joint. By drilling into the subchondral bone, one stimulates a healing process and by adding orthobiologics, one hastens the healing of those bony lesions.
Subchondroplasty is accomplished with a specially designed drill bit and the orthobiologic is introduced through a specially designed trochar needle that slides over the drill bit serving additionally as a guide wire. The entire process is accomplished through a small skin puncture with accuracy enhanced through fluoroscopy, real time X-ray. Because the drill bit causes little structural damage, there are few alterations in the rehabilitation process when compared to the joint intervention alone. While Orthopedic Surgeons have been addressing these bony lesions by a macro system for several years with documented success, our work, as was seen on the Fox News airing last Thursday night, is based on minimally invasive means thereby eliminating the need for prolonged restriction of weight bearing and crutch dependency. Additionally, by introducing Bone Marrow Aspirate Concentrate in addition to the present Calcium Phosphate adjunct, the patient should anticipate healing in weeks, not months. The first target was the knee but we have expanded subchondroplasty to the ankle and soon to the hip and shoulder.
Tags: arthritis, athletes, Benefits and Risk, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, stem cells, treatment, Ultrasound Guided Injection