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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Birds do it, bees do it, even Jack Nicklaus does it; I am talking about stem cells

In the ongoing initiative to remain in the forefront of cellular orthopedic offerings for arthritis, “a needle, not a knife”, it was time to advance my skills when dealing with low back pain. About 70% of my patients, in addition to major joint disease, present with degenerative disc and facet joint generated symptoms. At times, it is difficult to determine as to whether hip and knees symptoms come from those joints or are referred from the low back so off I went for Continuing Education. Arriving in San Jose on Thursday, mid- day, and activating my cell phone to see how the world might have changed over the past 4 1/2 hours during my flight, I found an e-mail from my daughter, a physical therapist:

Jack Nicklaus reveals his secret, experimental stem cell therapy in CNN interview
“I’m not a doctor, but I think that stem cell is going to change…the direction of orthopedics, totally,” Nicklaus said, remarking the procedure has given him the opportunity to keep teeing it up. “As long as my stem cells allow me…Golf is a game of a lifetime, I hope to play for my lifetime”. –Joel Beall

How about that one for timing; thank you CNN. Now we may add to the list of celebrities who have undergone regenerative medicine interventions but golfing great Jack Nicklaus deserves special attention. Unlike the star athletes who continually undergo stem cell and PRP interventions so as to compete such as Fred Couples, Steph Curry and an ever- increasing list; Nicklaus underwent a restorative procedure to his back so he could just enjoy a painless round of golf. It is Sunday and I am headed home. Now I am better prepared to help you restore your active lifestyle and overcome limitations imposed by osteoarthritis in a major joint or the low back.

The algorithm of care requires an office assessment and review of images including X-rays, MRIs and at times, a CT scan. Whether further preliminary study is needed will be subsequently determined; and I emphasize, the process may not be “one and done”. After age 45, it more often than not restoration, not regeneration, so maintenance may periodically be needed. Last of all, the improvement following any regenerative or restorative intervention may take 6 to 12 weeks at a minimum.

The next step is your phone call to schedule a consultation. (847) 390-7666
You may view my web site and watch the webinar at www.Ilcellulartherapy.com

A website update to include the low back is forthcoming

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News from the International Orthopedics Foundation Annual Meeting

News from the International Orthopedics Foundation Annual Meeting

I am sitting at my computer this morning writing the weekly Blog posting and not attending the IOF meeting taking place today in Broomfield, Colorado; yet I am reporting about the meeting. Instead of attending, I am preparing for a week-long ski adventure with my family next week in Vail, Colorado while trying to catch up in my practice. How is it than possible that I know what is taking place at the meeting? Listed below are five of the 10 ongoing or completed cellular orthopedic clinical trials in which I am a principal investigator or co-researcher. The preliminary and final data resulting from these clinical research initiatives is the outcomes foundation for what is being presented at the IOF podium today and tomorrow.

1) Stem Cell Counts and the Outcome of Bone Marrow Concentrate intra-articular and intra-osseous (subchondroplasty) interventions at the knee for grades 2 and 3 OA. (supported in part by Celling). Ongoing

2) Outcomes of Bone Marrow Concentrate (stem cell, platelet and growth factor) Intervention at the Knee for Grades 2 and 3 OA in 50 patients at 2 to 4 years. (supported in part by Regenexx)

3) Outcomes of Intra-articular Bone Marrow Concentrate versus those of combined Intraarticular and Intraosseous interventions for grades 2 and 3 OA at the knee at one year. (self-funded). Ongoing

4) How does the PRP and Mononucleated cell count affect the outcome of a BMC intervention for grades 2 and 3 Knee OA? (a joint project with Greyledge) Ongoing

5) Safety and Efficacy of Percutaneous Injection of Micro-Fractured Adipose Tissue for grade 4 Osteoarthritic Knees, minimum follow-up of 18 months in 30 patients (supported in part by Lipogems)

I had to prioritize; and since most of the arthritis data being presented is all or in part mine, I already know the subject matter. By staying home, I also found the opportunity to browse “stem cell” websites as suggested by ads in today’s newspapers or introduced by email blasts this week.  Wow, a patient acting more like a consumer is really at risk for succumbing to Regenerative Medicine “false news”.

If you want to learn more about the difference between the stem cell purveyors and a legitimate, FDA compliant, evidence based, cellular orthopedics initiative, call to schedule a consultation or to get a second opinion.

You may schedule a visit at (847) 390-7666

You may access my website and watch a webinar at   www.ilcellulartherapy.com

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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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My Algorithm If Stem Cell Intervention Doesn’t Last or Doesn’t Work

I am being forthright; based on my review of data, while 80% or more of my patients continue to enjoy
satisfactory outcomes at four years or more following a stem cell intervention, there are those whose
symptoms and functional limitations recur. Please be aware that when I undertake the care and
treatment of a patient with a symptomatic and function limiting joint, it is with the notion of
regeneration and long-term benefit. It doesn’t always happen; there are may possible explanations.
Most important though is the need to identify possible causes of potential failure at the beginning, and
that is why we have recommendations before and after a procedure as to how to manage alcohol, diet,
supplements and a rehabilitation protocol. We also review your past medical history to identify any
possible indication that your stem cells have been adversely affected by co-morbidity or prior
treatments.

Assume if you will that you adhered to the initial pre-and post-intervention protocol but now returned
to my office months or years later with recurring symptoms. First and foremost is an updated medical
history and physical examination. That is followed by repeat images including X-rays and an MRI.
Mechanical progression of joint injury may result from aggravation of the preexisting damage by
subsequent trauma. Then there is the reality of identifying new processes within or adjacent to the joint.
This morning, I returned the phone call of a southwest Wisconsin dairy farmer; not the same patient I
wrote about last week. He has been a patient for over four years with a full restoration of work related
activities and recreational pursuits following several regenerative interventional options. After three
hours of basketball, three weeks ago, his knee pain returned. I called him back while he was milking his
cows and it was the first time I have been “mooed” at over a cell phone. I requested that the patient
update his X-rays, MRIs and then allow me to reevaluate him. A repeat stem cell intervention with a
more advanced technology, a subchondroplasty in addition to the stem cell intervention of his joint?
The recommendations will be based on an updated evaluation. In my practice of cellular orthopedics, it
isn’t one and done. Additionally, some of the more advanced techniques are being covered in part by
health care insurance

If you want to learn more, call for an appointment (312)475 1893
You may access my web site at www.Ilcellulartherapy.com and watch my webinar

After I completed writing this Blog, I opened the Bone and Joint Newsletter.
Lead article: Study Suggests Knee Replacement Be Reserved for Those More Severely Affected by Osteoarthritis. A recent analysis found that the current practice of TKR as performed in the USA had minimal effects on quality of life and quality adjusted life years

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