FDA Compliant Therapies

For those who may have missed it, I was featured Monday night in a Fox 32 news report presented by Fox News investigative reporter Sylvia Perez.

http://www.fox32chicago.com/health/customers-warn-that-doctors-are-scamming-patients-with-fake-stem-cell-claims

Regular readers of my Blog are aware of the opinions I have frequently expressed regarding the charlatans and camp followers that have taken advantage of the regenerative medicine marketplace promising to cure arthritis, Alzheimer’s, Alopecia, ALS, Autism, and every malady known to mankind finally ending at the letter Z. They don’t exclude spinal cord injury, residuals of stroke nor ED while they are at it. The message regarding what stem cells can do is found in newspaper ads, television commercials and radio spots, the latter in the Chicago listening area by a well-known sports announcer. Either attend a seminar or make an appointment for treatment; they will cure your disease, eliminate pain and do away with your suffering. “Call now to schedule an appointment”.

For a free lunch and without an evaluation or examination, you can undergo an amniotic fluid intervention that is “regenerative” as it is claimed, at a cost in the neighborhood of $5,000. I have been involved in amniotic fluid clinical trials for four years underwritten by the largest provider of amniotic fluid in the nation; and our first statement to participants in these clinical trials, without charge for the injectate, is that there are no living stem cells in the amniotic fluid once processed, sterilized, frozen and fast thawed for usage. Hold on, there is more. On September 16, 2017 the FDA published mandatory guidelines: any and all regenerative agents must be autologous and homologous. In plain speak the injectate must come from the same patient and be used as nature intended. Stem cells from donor sources are not compliant.

Featured in the Fox News special report are two patients. One had undergone a complete medical history, physical examination and skeletomuscular evaluation prior to his Cellular Orthopedic intervention enjoying a marvelous outcome; the other, an amniotic fluid injection into his knee without any prior evaluation or preparation and an awful end result. You may watch the actual report by clicking on that underscored above.

One of the standard of practice methodologies in which we take great pride and which I believe separates us from the madding crowd of regenerative medicine camp followers and charlatans; is our evidence based cellular orthopedic approach.  In preparation for a scientific podium presentation in two weeks, we are collating our outcomes data at one year for patients who underwent a combined intraarticular (into the knee) and intraosseous (into the subchondral bone) autologous bone marrow and growth factor intervention for osteoarthritis grades two and three. At six weeks, we recorded a 22% improvement in pain relief; 42% at six months, and 89% at 12 months. In future blogs, I will breakdown the outcomes data further and expand on our documented outcomes based on our several cellular orthopedic options.

To learn more, you may review my web site and watch my webinar at www.ILcellulartherapy.com

You may schedule a consultation by calling (847) 390-7666

Tags: , , , , , , , , , , , , , ,

Accuracy, Ethics and Corrections

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: , , , , , , , , , , , , , , , , , , , , , ,

Plain Language Summary of Regenerative Medicine

Plain Language Summary of Regenerative Medicine

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: , , , , , , , , , , , , , , , , , , , , , , ,

A Stem Cell Report from the NBA Playoffs

A Stem Cell Report from the NBA Playoffs

“Dwight Howard dominated the paint during Tuesday’s series-clinching victory, finishing with 18 points, 19 rebounds, four steals and four blocks.” (From Yahoo sport)  Three months ago, the following appeared in the Press/News from ESPNDallas.com “Dwight Howard Out Indefinitely. There is no timetable for Houston Rockets center Dwight Howards return.” There are many other athletes who undergo Regenerative Medicine-Cellular Orthopedic interventions during the course of the year, they are not as public about it but there is successful return to sports, more often than not. If you imagine the forces generated across the knee in a 6’11’’, 265 lb. professional basketball player, you must conclude that his regenerative medicine intervention is a success for a continually painful knee.

Cellular Orthopedics is here to stay and is rapidly gaining a foothold as the non-operative treatment regimen for skeletal muscular trauma and the progressive restrictions imposed by degenerative arthritis. This past weekend, I was in Southwest Wisconsin fly fishing and cycling. Wading up a spring creek and climbing up and down the cliffs is as demanding as playing center on a professional basketball team. Cycling for three hours up 1500 foot climbs depends not only on conditioning but on functional knees. It was possible for my buddy and me in part because of the several cellular orthopedic procedures I have completed on him in the past three years. We have many more similar trips planned.

Bone Marrow Aspirate Concentrate-Stem Cell treatment is only one of the possibilities available for helping a patient postpone or avoid a joint replacement, diminish pain, increase motion and assist in returning an injured or arthritic individual to well being and a full recreational profile. From Concentrated Platelet Rich Plasma to Bone Marrow Aspirate Concentrate-Stem Cells, there are several alternatives for altering the natural history of post traumatic and degenerative arthritis. Many more offerings are in the works and I will continually update you as to when these latest interventions become available. In the meantime, please understand that while I don’t have to break a bone to best understand how to treat a fracture, my treatment recommendations for Cellular Orthopedic intervention concerning both post traumatic arthritis and degenerative arthritis in part are influenced by my own experiences so I will continue to report on such. To learn more about what is available in Regenerative Medicine and what clinical trials are in the works, make an appointment for a consultation.

 

847 390 7666

Tags: , , , , , , , , , , , , , , , , , ,

Regenerative Cellular Staging

Regenerative Cellular Staging

Musculoskeletal Care of the Mature Athlete

A 67-year-old man came to my office to learn more about Bone Marrow derived Stem Cells for his arthritic knees. While he had been discouraged by his sports medicine physician from seeking the Regenerative Cellular alternative, he was not ready to undergo a bilateral total knee replacement after having investigated the potential complications associated with the surgery. I started with a review of his medication profile and determined that BMAC/Stem Cells might not produce the quantity and quality potential I would want to see to justify the procedure. My concern had to do with the adverse effects of certain medicinals on stem cell numbers. I offered an alternative, Concentrated Stem cell Plasma.

The development of Regenerative Cellular interventions for the management of arthritis started several years ago with Platelet Rich Plasma. Platelets not only play a role in initiating the clotting cascade, they contain an abundance of anti-inflammatories and healing agents termed growth factors. At the outset, clinicians performed a venous puncture and filled a test tube with blood. The latter was now spun in a centrifuge and the plasma with platelets suspended was injected in the arthritic knee. Within a year, it became apparent that two or three staged PRP interventions would result in better outcomes. About a year ago, the group of physicians at Regenexx began concentrating the Platelet Rich Plasma 10X and the results of treatment have been very encouraging in that patients did better and for longer than with standard PRP. More recently, we have developed a better way to activate with a faster and longer acting release of growth factors.

Bone Marrow Aspirate Concentrated/Stem Cells remain the best possible alternative in our Cellular Orthopedic Regimen at this time. Concentrated Stem Cell Plasma (PRP 10X) is a reasonable alternative although with a shorter outcome potential and probably to a lesser extent. No bridges are burned. I have suggested the 10X PRP option to patients heavily dependent on pharmaceuticals for co-morbidities or when I anticipate a possible compromise in the quantity or quality of stem cells because of age or other factors. Primum Non Nocere, First No Harm. There is nothing lost and a lot gained by a staged approach to the Regenerative Medical management of arthritis.

Addendum: I now have several patients who were managed as above when their pharmaceutical profile excluded them from a stem cell procedure; that went on to loose weight and get fit, and minimize their medication dependency. By so doing they became reasonable candidates for stem cells; and, now are enjoying the longer term and more comprehensive benefits of Bone Marrow Concentrate Stem Cell intervention.

 

Tags: , , , , , , , ,

Pin It on Pinterest