Dec 27, 2017
Or as Dan Brown’s Origin explores, “Where did we come from, where are we going?”
It seems customary to make predictions at this time of year; but I want to begin by looking back four decades. It is more than reminiscence. Until managed health care was introduced into the marketplace undermining the doctor-patient relationship, a patient would make health care decisions for the most part based on the trust and confidence established with the family physician. Then came what was promoted as New Horizons of Health Care; mainly insurance based decision making. Hailed as the means of controlling spiraling health care costs, the doctor-patient relationship was no longer primary. The model changed health care decision making from a physician to a non-professional employee sitting in front of a computer and determining your care based on a cost containment paradigm. The next step in devolution was the appearance of Web MD and the like were in everyone thought they could become a physician and expert in some aspect of health care by simply clicking on a mouse. No need now for a physician or expert any longer; why bother with someone educated in medical school and struggling through a lengthy residency and then fellowship? Then appeared the next step in Gulliver’s Travels, further devolution or the opportunity for camp followers and charlatans to exploit the belief that marketing would outweigh evidence and science in a patient’s decision-making process.
Unfortunately, the FDA is only now beginning to police these amniotic fluid stem cell purveyors offering false hope. We have experienced a study process of lowering standards, further eroding norms, and peddling fiction. Where are we going; where should you turn for orthopedic care?
Today, I am undergoing a cellular orthopedic intervention on my knees so as to assure my best possible performance when I fly fish, ski, cycle, and maintain my fitness profile in 2018. The process is an autologous therapy (from me to me), that I have wanted to bring to the United States since Kobe Bryant and many more travelled to Dusseldorf, Germany, to have completed over seven years ago. The promise is to do more than treat my knee pain; rather I hope to slow the progression of my Osteoarthritis with this cell-concentration system.
The poet Robert Browning wrote a poem, Rabbi Ben Ezra, often cited as we age and I will quote the opening stanza here:
“Grow old along with me! The best is yet to be”
You may read the entirety at the Poetry Foundation website. You may watch my webinar on my web site at www.Ilcellulartherapy.com. Call to schedule appointment (312) 475-1893.
Read this Blog to monitor my response to treatment
Tags: arthritis, autologous therapy, Clinical Trial. Mitchell B. Sheinkop, IRAP, Knee Pain Relief, Kobe Bryant, Mesenchymal Stem Cell, Osteoarthritis, Platelet Rich Plasma
Dec 14, 2017
After my last blog was posted, a patient sent me a brochure she had received while attending a Regenerative Medicine Seminar focusing on how “stem cell therapy could change your life”. Within the brochure was a full page dedicated to how amniotic fluid stem cell therapy could treat ALS, Autoimmune Disease, Avascular Necrosis, Cartilage Damage, Rheumatoid Arthritis, Traumatic Brain Injury, to name just a few of the 30 listed conditions. The marketing hype went on to indicate “_________ is building the largest network of FDA compliant stem cell centers in the US.”
Last week I emphasized that in order to FDA compliant, Regenerative Medicine must follow several regulatory requirements:
- Minimal Manipulation of the cells or tissue bearing the cells
- Autologous source and homologous application
Minimal manipulation of cells means that they can not be cultured nor can tissues be treated with enzymes to release the stem cells. One such example is a prohibition on fat being subjected to the enzyme collagenase. In simple terms, it is contrary to FDA regulations to perform a liposuction, treat the recovered fat with an enzyme, and inject the cells into a joint or other skeletomuscular structure. As of this writing, I am still seeking clarification on using a mechanical means to emulsify the fat and use the end product in the musculoskeletal system.
Autologous is defined by Merriam-Webster as “involving one individual as both donor and recipient”. It then follows that it is contrary to FDA regulations to use the stem cells in amniotic fluid when recovered by amniocentesis in the musculoskeletal system of a different individual. Add to the latter, the fact that there are no living stem cells in amniotic fluid once sterilized, frozen or lyophilized for preservation and fast thawed for intervention.
Next, I will address homologous as “having the same relation, relative position, or structure” according to the Oxford dictionary. From the FDA oversite standpoint, you can’t put stem cells from amniotic fluid into a joint nor can you introduce fat into a joint. For those patients with arthritis and related orthopedic conditions, beware of the scammers, charlatans and camp followers. As well, for those with degenerative diseases other than orthopedic, be forewarned. There are scoundrels out there very willing to fleece you and take advantage of desperation. For those looking to address non-orthopedic degenerative conditions such as ALS, Autoimmune Disease, Congestive Heart Failure, Multiple Sclerosis, etc., clinical trials are taking place at major medical centers. You may learn about the various trials at NIH.Gov. The FDA warned the non-compliant clinics that they have three years so cheaters will continue to cheat.
From the skeletomuscular and arthritic standpoint, there are clinical specialists available to address your arthritic and other orthopedic problems using FDA compliant Platelet and Bone Marrow derived options just as credentialed as all the other specialties in medicine and surgery. As an orthopedic surgeon, I for one have the scientific outcomes data to support my cellular orthopedic initiatives. To learn more about evidence based cellular orthopedics call 312 475 1893 to schedule a consultation.
Tags: arthritis, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Mesenchymal Stem Cell, regenerative medicine, stem cells
Dec 6, 2017
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
Tags: adipose tissue, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Mesenchymal Stem Cell, Minimal Manipulation and Homologous Use, Orthopedic Care, Orthopedic Surgeon, Platelet Rich Plasma, PRP, regenerative therapies, stem cells
Nov 29, 2017
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
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mesenchymal Stem Cell, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, regenerative medicine, stem cell treatment
Nov 22, 2017
As regular readers of this Blog are aware and as well, those patients who seek consultation in my office, my cellular orthopedics practice is based on clinical evidence. While the largest marketer of stem cells in the Midwest, bases a recommendation for a product without scientific evidence or even anecdote, my practice is evidence based. While it is true that I can site anecdote after anecdote about a successful outcome, the scientific process requires that I provide statistical support for what I do. The subject of this particular blog is to share with you how far I will go to gather that evidence.
About six months ago, I completed a combined Bone Marrow Concentrate Intra-articular (into the joint) /Subchondroplasty (into the bone) in the right knee of a dairy farmer, in his early 60s, living in Southwest Wisconsin. He was able to follow up at my office in Des Plaines twice following the intervention; but owing to the fall harvest, he had been unable to return for the third follow up in a timely manner. My desire is to assure the success of the procedure, rather than having completed a telephone interview, my wife and I headed out this past weekend to Dodgeville, Wisconsin, where I completed the full evaluation in a booth at the local Culvers. In addition to the usual historical review of progress, I completed a Physical Examination of the patient including circumferential measurement of the thigh, knee and calf using a tape measure and an assessment of his range of motion using a goniometer for accuracy. I think that the diners at Culvers were just as fascinated at what was taking place in our booth as I was watching the customers in the drive through ordering an early lunch while carrying a recently harvested buck in the back of their pickups. It is deer season in Wisconsin.
Suffice it to say that my patient was thrilled at my willingness to save him a trip to Chicago but he was even happier about the outcome in his arthritic knee. I was thrilled at his response to care. Whereas prior to the right knee intervention, he had constant pain and limitation in function, at six months, the pain and swelling are gone and he has unlimited function be it on stairs, kneeling or climbing in and out of the tractor. What separates me from the madding crowd is the data and evidence for which my recommendations are advanced. Incidentally, two blogs ago, I listed our clinical trials, the basis for our evidence based practice. Below is the trial in which my Wisconsin patient is enrolled and for which I sought follow up:
- 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
His results are so good that his wife decided to be next in line for her knee that did not respond well to arthroscopic surgery two years ago.
Whether you didn’t respond to surgery or haven’t had surgery, call 312 475 1893 to schedule an appointment or watch my webinar on the website www.ilcellulartherapy.com
This Thanksgiving week, let me give thanks to those who read this Blog
Tags: arthritis, bone marrow, Bone Marrow Concentrate, cellular orthopedics, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Knee Pain Relief, Mesenchymal Stem Cell, Osteoarthritis, regenerative medicine, stem cell treatment
