Oct 16, 2015
Tissue Regeneration has become the new standard for Grades 2 and 3 arthritis. Three years ago, I anticipated the future recognizing that the risks of joint replacement surgery were not fully taken into account when a surgeon recommended a new hip, knee or shoulder. Certainly, in advanced arthritis (Grade 4) there is little alternative for pain relief and restoration of function; but for Grades 2 and 3, do the risks outweigh the benefits? What is not taken seriously enough are the risks inherent in a surgical procedure. A recent scientific article reminds us of those risks.
“Knee, hip replacements might be bad for the heart short-term.”
“Contrary to some recent research, Boston-based researchers found osteoarthritis patients who had total knee or hip arthroplasty procedures were at increased risk of myocardial infarction in the early post-operative period. Their findings, published Aug. 31 in Arthritis & Rheumatology, a journal of the American College of Rheumatology, indicate long-term risk of heart attack did not persist, while the risk for venous thromboembolism remained years after the procedure.”
Up until 2001, the patient undergoing a joint replacement was discharged on post operative day four or five. Any complications taking place were reported as a postoperative morbidity, rarely, as a mortality. Today, a patient will leave the hospital between 23 and 36 hours following a joint replacement. Should, if, or when a complication ensues, it may never be recorded as a readmission to another hospital if not registered. Medicare has started penalizing hospitals for high readmission rates within 30 days of a discharge but this is only a recent development and doesn’t as of yet, include readmissions to a second location.
Last time, I indicated I would start updating the reader with new developments in the field of Regenerative Medicine. The goal of regenerative therapies is to modulate the stages of healing including inflammation, cell migration and proliferation. We do this though use of tissue grafts such as Bone Marrow Aspirate Concentrate.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Sep 17, 2015
In the last week, I have become aware of four companies developing new regenerative medicine product for Musculoskeletal Care of the Aging Athlete. What I find extremely interesting is the fact that three years ago, when I entered the practice of using bone marrow aspirate concentrate in an attempt to postpone or possibly avoid a joint replacement in an arthritic knee or hip, the orthopedic community was very critical telling patients that regenerative medicine was still ten years away. Fast forward three years and four new initiatives into the emerging field of regenerative medicine have come to my attention; underwritten by orthopedic surgeons or companies that have produced prosthetic joints for over 30 years. All of the product in development has not yet been approved by the FDA and many developing products are still being tested in Europe. What we at the Regenerative Pain Center offer is within FDA guidelines and approved by all regulatory agencies of the government. At the same time, I am very much aware of what is taking place nationally and internationally; when a newer regenerative medicine product is made available and FDA approved, we at the Regenerative Pain Center will be aware and closely evaluate as to whether it should be incorporated into our service line.
Let me be candid, our success rate is not 100 per cent. There have been three or four hip patients that have not provided the outcome the patient sought or that I hoped to provide; namely, avoidance of a hip replacement. On the other hand, the vast majority of hip bone marrow aspirate concentrate procedures are still allowing the patient a very full return to activities with about 70% percent patient satisfaction at a minimum of one year. When it comes to those who sought help for an arthritic knee, we have done even better with an 85% patient satisfaction outcome at a minimum of one year. Several of those patients had reached a plateau at six months but realized a marked improvement in the pain score with a Platelet Rich Plasma refresher. When a patient elects to under go a bone marrow aspirate concentrate hip or knee intervention at the Regenerative Pain Center, that patient may be assured that what we are doing is based on FDA guidelines and our clinical outcomes research. In addition, each patient should recognize that Regenexx continually statistically reviews our outcomes data. Last week, we recognized that those who underwent Cellular Orthopedic interventions for an arthritic knee did best when the cell count of mononuclear cells exceeded 400 million. Be aware that we count the cells in every Regenerative Medicine procedure. Our approach is no longer “this is the way we do it.” Our approach is based on experience and outcomes research, the same that I used in a long joint replacement career.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, FDA, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, Regenerative, Regenerative Pain Center, Regenexx, stem cells, treatment
Jun 11, 2015
Cellular Orthopedics for the Musculoskeletal injury and Degenerative Arthritis
What is the problem?
Trauma and Osteoarthritis are part of the cycle of life. Muscle, ligament and tendon injuries frequently occur during sports related activities or accidents; degenerative arthritis may be post traumatic by many years or occur as part of the aging process
What treatments are available?
As of today, it includes Platelet Rich Plasma (PRP) following several protocols and Bone Marrow Aspirate Concentrate (BMAC) rich in stem cells, growth factors and anti-inflammatories called Cytokines. As of next week, all may change as the Orthobiologic update taking place in Las Vegas over the weekend will potentially introduce an entire new menu of therapeutic intervention alternatives for musculoskeletal injury and disease.
What is Platelet Rich Plasma?
Platelets are part of your circulating blood producing growth factors that assist in repair and regeneration of tissue. When a high concentration of platelets are created via the centrifuge, healing may progress more quickly and pain may be reduced
What is Bone Marrow Aspirate Concentrate?
Taken form the back of your pelvis, aspirated bone marrow may be concentrated and prepared allowing for pain relief, improved function, a more rewarding quality of life, and possibly influence the Bio-immune response of degenerative arthritis
What is Amniotic Fluid Concentrate?
The source is the pregnant woman coming to term and delivering via Cesarean section. The recovered amniotic fluid is processed, concentrated, and now available as an alternative to Visco-supplemenation with hyaluronic acid. It is a new option and data concerning the length of pain relief is still being determined.
Do these Regenerative Medicine alternatives work?
When properly applied the answer is yes. What we don’t know is for how long? The effect of Platelet Rich Plasma in injury is intended to speed up the repair process. In the case of Amniotic Fluid, the outcomes are still being studied without a known end point. I have been involved in studying the clinical outcomes of Bone Marrow Aspirate Concentrate intervention for osteoarthritis. The paper I will be presenting this weekend confirms satisfactory results up to two years. The data collection continues.
Is there a downside side to Regenerative Medicine and Cellular Orthopedics?
In my experience the answer is yes and no. Yes because there is no indemnification for the new world of regenerative medicine; care is an out of pocket self pay undertaking because the field is new and five year outcomes data still not available. On the other hand, at three years, I have seen no adverse events and the vast majority have responded well with improved function and quality of life. Out of over 600 knees and over 100 hips, to the best of my knowledge, seven have gone on to a total joint replacement.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, C-SCP, Clinical Studies, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, PRP, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
May 28, 2015
Osteoarthritis of the knee is one of the leading causes of functional limitation and progressive deterioration in the quality of life. Nonsurgical treatment of the osteoarthritic knee has been the usual and customary weight reduction directive, recommendation for physical therapy, prescription for non-steroidal anti-inflammatories, followed by injections with corticosteroids and hyaluronic acid. The goal is to reduce pain and improve function but the classical non operative approach is not universally successful or long lasting. Alternatives are continually sought to provide pain relief and improve functional outcomes.
Recently, there has been a major initiative to introduce Amniotic Fluid in the treatment of the osteoarthritic knee. Allograft (from a third party) amniotic tissues have a long history of clinical use having been first reported in 1938. It is thought to be a homologue to synovial fluid, acting as a cushion to protect and lubricate in the closed environment of the knee. A recent study measured the safety and efficacy of processed allograft amniotic fluid in treating osteoarthritic knees using common, validated outcomes measurement tools. In the registry review, early outcomes suggest that the use of processed amniotic fluid allograft may offer a safe and effective treatment for OA of the knee for 90 days. The suggestion is that this treatment may be more durable than single corticosteroid injections and perhaps hyaluronic acid treatments. The study providing the background for this blog is still in progress. Of interest is the fact that no claim is made in the article supported by the pharmaceutical company that amniotic fluid is chondrogenic or contains stem cells. The latter is an extremely important consideration; beware of those who promote amniotic fluid on their web sites as providing viable stem cell content. As of this time, while amniotic fluid may contain cytokines (anti-inflammatories) and growth factors, it is only to be considered in the same category and comparable, perhaps longer lasting than a corticosteroid injection or a hyaluronic acid intervention.
The standard of Regenerative Medicine and Cellular Orthopedics remains Bone Marrow Aspirate Concentrate as the best source of anti-inflammatory cytokines, growth factors and only FDA approved source of viable adult mesenchymal stem cells. In spite of the FDA approval mandate, as recent as this morning, I received an invitation to attend a course that would teach me how to use adipose derived stem cells in my practice. Let me emphasize two points, Amniotic Fluid does not have viable stem cells until proven otherwise and adipose derived stem cells are illegal for use in the musculoskeletal system. That being said, even if adipose derived stem cells were FDA approved and thus available; bone marrow aspirate concentrate provides the Cytokines and the growth factors not found in fat while bone marrow aspirate concentrate provides stem cells not found in processed amniotic fluid.
Tags: Amniotic, arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, FDA, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenexx, stem cells, Synvisc, treatment
May 7, 2015
Prolotherapy
In spite of what you may read and hear about repeated injections of 12 ½ % dextrose into your joint or in the soft tissues surrounding your joint, there is no scientific evidence to support the claims regarding a regenerative influence from Prolotherapy. That is not to say it might or could lessen pain around a joint; but the benefits, if any, are anecdotal in nature and fall under the realm of homeopathy. It belongs under the same classification as Acupuncture; there are followers, anecdote and practitioners but an absence of scientific proof as to how it works. Yet, even with paucity, if not absence of scientific evidence, there is no end to web sites extolling the regenerative nature of Prolotherapy.
From science to tabloid
This week, my office and email were inundated following the headline in the Monday Wall Street Journal concerning a 3D printing of a medial meniscus lattice into which stem cells had been injected. A total of one patient was featured who had an experimental meniscus surgically introduced to replace a previously torn medial meniscus. While in years to come, this may become common place, there are limited indications and many more years of clinical trial ahead before an artificial meniscus becomes a standard of practice. After age 40 or so, meniscal injury as documented on an MRI is more often than not accompanied by arthritis. Post traumatic arthritis and degenerative arthritis are contraindications to meniscal replacement and even are associated with a less than satisfactory outcome to existing arthroscopic interventions. I must remind the reader that degenerative and post traumatic knee arthritis may be reflected on the MRI as an abnormal meniscus but in addition, physical examination is compatible with an altered range of joint motion and mechanical axis deformities.
A Regenerative Medicine Offering with emerging Scientific Evidence
I am finishing up my statistical analysis concerning 170 patients with degenerative and post traumatic knee arthritis who have undergone Bone marrow Aspirate Concentrate/Stem Cell knee care in preparation for my presentation at the June meeting of The Orthopedic and Biologic Institute. After two years of follow-up, there is a statistically significant improvement in diminishing pain, increasing range of motion, enhancing well-being, and facilitating return to or maintenance of a highly active recreational profile. This is scientific evidence and the basis for my Regenerative Medicine approach to helping a patient manage arthritis.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Feb 2, 2015
The world of Regenerative Orthopedics began in the United States with the publication of a scientific article reporting the results of platelet rich plasma in the treatment of knee arthritis. That took place about six years ago. No one really understood at the time of the publication why something so important in the clotting cascade of the human body would be beneficial in the treatment of an arthritic joint.
The next step in improving results of Platelet Rich Plasma injections for an arthritic joint was the understanding that whereas one injection would help, three injections over a three month period would improve outcomes. Scientists began further efforts at understanding why the platelet, so critical in the clotting cascade, would be beneficial in treating arthritis, and soon a better understanding of how platelets function came to be appreciated.
Platelets are the primary source of bioactive tissue growth factors. When concentrated they are potent. When activated, they release their growth factors and cytokines in clinically active quantities. Regenexx has developed a formula for superior concentrations and immediate activation. Whereas most Platelet Rich Plasma is created at bedside, we create ours in a laboratory with maximum concentration and prompt activation. Our research supports better stem cell growth following the Regenexx SCP procedure. Although the Regenexx Stem Cell Plasma formula is part of the Bone Marrow Aspirate Concentrate algorithm, we now are able to offer it when indicated as an independent intervention when Bone Marrow Concentrate is not possible. In addition, it is a wonderful “booster” when anticipated milestones with Bone Marrow Aspirate Concentrate are not met. Let me cite two patient examples.
Two years ago, an 83 year old man was selling his condo in Palm Springs because his arthritic knee would no longer tolerate a round of golf and his co-morbidity posed a very high risk for a joint replacement. He sought consultation and I recommended a Regenexx SCP intervention. Three weeks after the procedure, he took his condo off the market and returned to Palm Springs for the winter migration from Chicago. I spoke with him via phone in August and he had purchased his tickets for the return migration to the desert this winter.
36 weeks ago, I performed a Bone Marrow Aspirate Concentrate/Stem Cell intervention into the right hip of a 29 year old man with early onset degenerative arthritis. At six weeks, he was 25% symptomatically improved. At 12 weeks, he was 50% improved. At 18 weeks, he was still 50% improved so I administered a C-SCP booster. At 36 weeks he is 80% improved and thrilled. Cellular Orthopedics requires a continuum of monitoring and possibly more than one intervention.
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Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, PRP, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
