Looking back to see the future of Cellular Orthopedics

My regenerative and restorative Cellular Orthopedics practice is for the most part, evidence based. By that I mean, the outcomes data collected over these past five years regarding the several thousand patients with skeletomuscular afflictions that I have treated with a selection of alternatives using a needle and not a knife is generally based on regenerative and restorative interventions. While not everyone has experienced a dramatic change in symptom relief and functional improvement, many have. The statistical outcomes evidence follows a bell shaped curve with some experiencing immediate improvement as I have in both my hips and knees, while most take several weeks or longer with a continuing improvement up to 18 months post intervention. While it is true that five percent of patients are not satisfied after several years and have gone on to a joint replacement, 95% of my patients are well satisfied and have returned to, or never quit doing what they love.

At the onset of my cellular orthopedic initiative, the interventions were solely based on Platelet Rich Plasma options and Bone Marrow Concentrate; today, our menu of services can be customized so as to meet the needs of all seeking to improve the quality of life and avoid a major surgical procedure. Not only can I concentrate PRP as needed, I can customize the concentration to meet a patient’s particular needs using hemo-analysis. Bone Marrow Concentrate rich in Adult Mesenchymal Stem cells, Platelets, Growth Factors and Precursor Cells is still the foundation of my practice, however for the past year, I am able to offer a Platelet Concentrate derived Growth Factor and Protein Solution option when indicated.

Then there are those whose co-morbidity or prescription medication dependency excludes them from the aforementioned autologous choice of options. As of this upcoming Tuesday, I have acquired an intervention technology that will help patients seeking to a void a total joint replacement who are not candidates for existing regenerative medial offerings. There are many reasons to explain a 5% failure rate including genetic cartilaginous variations, any bell shaped curve will have a small number who don’t pass the final examination. Incidentally, if and when such occurs, I offer another intervention frequently at no charge or certainly at a discounted rate.

Should you want to learn more or schedule a consultation, call
(312) 475-1896. You may visit my web site where you will find the webinar at www.Ilcellulartherapy.com.

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The U.S. FDA regulation of cell therapies finally is enforced

“Mitch, not sure if you heard, but the FDA via the DOJ has requested injunctions against the mothership clinics of Berman and Lander, as well as the US Stem Cell clinic run by Comella. We can hope that criminal indictments might follow, since they certainly are some of the most flagrant violators of the law in recent med I can think of. The SCIA group can’t be too far behind. It seems that advertising all kinds of cures for everything that ails the patient makes you a higher priority target.” (Personal communication)

I am dedicated to providing patients with the best possible care in regenerative medicine and am pleased to announce that I have adopted a technology platform developed by Greyledge Technologies (Vail, CO). Their technology to generate platelet-rich plasma (PRP) and bone marrow-derived cell concentrate (BMC) is derived from successfully operating a laboratory that is registered with the FDA (listed as a “component preparation and collection facility”, FEI 3008724474), which has cleared two audits with no issues. Based on their platform, I offer my patients customized therapy, since each preparation is analyzed for platelets, red blood cells and white blood cells (among 23 parameters), which I review prior to treatment. This knowledge permits me to make adjustments based on my more than 40 years of experience in orthopedic surgical and now cellular orthopedic practice. No other system or technology gives me this kind of capability to personalize your treatment.

As a result of the technology I have adopted, my office has been able to create a scientific outcomes data base using the same parameters in cellular orthopedics as when I was the director at one of the five largest joint replacement programs in the country. At that time, I pioneered the integration of patient are with research and education. The latter allowed me to rise to the position of full professor; having publish over 75 scientific articles in the field of hip and knee joint replacement. I am happy to update you with the fact that I am at it again. On June 10, my paper concerning the preliminary outcomes of combined intraarticular and intraosseous stem cell intervention for knee arthritis will be presented in Las Vegas at of The Orthopedic and Biologic Institute (TOBI) annual meeting. The manuscript concerning Autologous Bone Marrow Concentrate and Platelet Product for Symptomatic Knee Arthritis: A Randomized Controlled Trial, Minimum 2 Year Follow-Up was submitted to a major orthopedic journal and is one of three papers I have been invited to deliver from the scientific podium of The Medrebels, October 26 to 28 meeting in Austin, Texas.

If you want to avail yourself of the best opportunity to postpone, perhaps avoid a joint replacement for arthritis while enjoying pain relief and restoration of an active life style, chose science over advertised anecdote. Call (847) 390-7666 to schedule an appointment. You may access my website and watch the webinar at www.Ilcellulartherapy.com.

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Use and Misuse in Regenerative Medicine

I write this Blog as an Orthopedic Surgeon following the 2018 annual meeting of the American Academy of Orthopedic Surgeons, just concluded in New Orleans. The topic matter is of sufficient concern that Use and Abuse of Biologics became an agenda focus receiving several hours of attention.

Clinical use of biologics to treat all health problems has greatly outpaced the evidence. Every office day, patients bring advertisements about Stem Cells appearing in the print media. The enticing cure all claims and testimonials are quite seductive. Concerns over misinformation from direct-to-consumer marketing of unproven treatments have led to recent calls to action from government and scientific agencies, including the National Academy of Sciences and the American Association for the Advancement of Science.

These calls to action are of special relevance to orthopedics because a recent study showed that more than 85 percent of 351 businesses, which represent 570 clinics across the country, were marketing “stem cell” treatments for musculoskeletal problems. Analyses of these treatments show a diversity of offerings with most clinics using preparations that do not contain clinically significant numbers of stem cells. Widespread use of these cash-for-service, unproven, and poorly described treatments raise concerns for public health and safety.

The Academy collaborated with the National Institutes of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS) and held a think tank symposium on “Optimizing Clinical Use of Biologics in Orthopedic Surgery” on Feb. 15–17. 2018, at Stanford University to accomplish the following objectives:

  1. establish a clear, collective impact agenda for the clinical evaluation, use, and, optimization of biologics in orthopedics
  2. develop a guidance document on clinically meaningful endpoints and outcome metrics for the evaluation of biologics for common orthopedic problems

The symposium addressed key issues including poor definition of treatments and mechanisms of action; lack of standardized data and outcomes collection and reporting in existing clinical studies; and minimal evidence to support the myriad of ailments treated with these products. Leaders from clinical medicine, research, and government, as well as young investigators selected through a competitive process, participated in the event.

I am happy to be one of the first orthopedic surgeons in the Midwest limiting my practice to cellular orthopedics. Additionally, based on my model of having integrated patient care with outcomes surveillance as a joint replacement surgeon, anticipating and contributing to the new world of evidence-based regenerative medicine, I already have in place a cooperative venture allowing me to measure the platelets, growth factors and now stem cells that have been injected into a joint or the bone adjacent to that joint. I don’t know of any other practice or center that can make this claim. My team has entered into discussions to designate our model as the foundation for the future methodology of clinical evaluation, use and optimization of biologics in orthopedics.

As a patient, you have a choice to make: either respond to a marketing scheme or be educated and seek evidence before undergoing a “stem cell” procedure.

To schedule an appointment call 312 312 475 1893

Visit my web site and watch the webinar   www.ilcellulartherapy.com

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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

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“Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-based Products: Minimal Manipulation and Homologous Use”

On November 16, 2017, The FDA posted definitive guidelines concerning what meets minimal manipulation rules and regulations and what is accepted under the practice of medicine guidelines in the specialty of Regenerative Medicine. The FDA further restated the requirement that regenerative medicine be governed by homologous use. As I interpret the guidelines there are winners and losers:

Winners
Physicians who use compliant regenerative therapies:

  • Amniotic fluid without stem cells
  • Blood-derived preparations (e.g., PRP, PPP)
  • Bone marrow aspirate

Losers
Physicians who use non-compliant regenerative therapies:

  • Adipose tissue-derived materials obtained by enzymatic digestion
  • Amniotic fluid with cells Cord blood derived materials (non-autologous treatments)
  • Stem Cell Clinics that advertise about using amniotic fluid as a source of stem cells and regenerative therapy along with those clinics that treat everything from alopecia to ALS to arthritis

You might ask how is that different from the current situation? First of all, the FDA Commissioner has stated in press releases that the FDA is going to go after bad actors. The Cures Act provided for increased funding to the FDA, which we suspect the Commissioner will use in part to go after the bad actors. Also, the FDA wrote in their Guidance on Minimal Manipulation and Homologous Use that “healthcare providers” need to pay attention. We have never seen them explicitly refer to the doctors and clinics providing regenerative medicine. Finally, the FDA indicated that there would be a transition period (3 years) during which manufacturers would need to enter the RMAT program to get their non-compliant products properly approved; or else. And the reason that there could be teeth in the “or else” is that the FDA will get lots of fees from all of the non-compliant products entering the RMAT program.
Last of all, what the FDA did not address as part of consumer protection; but what I incorporate in my daily practice is evidence based intervention.

Now that you are better informed and have an idea as to the laws governing our regenerative medicine marketplace, stay away from the Charlatans and Camp Followers. Then take the next step and ask your physician for the Outcomes Evidence on which a regenerative intervention for your arthritic joint is based before undergoing a procedure. To better understand that evidence call for (312) 475 1893 to set up a consultation

You may watch my webinar by accessing my web site www.ilcellulartherapy.com.

* Minimal Manipulation and Homologous Use

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Combining Bone Marrow Concentrate into the joint with Subchondroplasty

Combining Bone Marrow Concentrate into the joint with Subchondroplasty

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.

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