Feb 9, 2018
The March 2018, edition of Consumer Reports includes an article written by Jenseen Interlandi that is worth the read for both what it does say and the questions it raises. I welcome the critical review of Stem Cell Therapy whenever an article appears because I too am critical of the charlatans, camp followers and those fleecing the public. In the Interlandi article, the reader immediately finds one such example of a so-called Institute in Tampa, Florida victimizing those with chronic pulmonary diseases; but you don’t have to travel to Florida to find such practices as were reported on by Fox 32’s Sylvia Perez in her investigation featured Monday, January 29. If you missed it, all you need to do is click on the hi lighted below:
http://www.fox32chicago.com/health/customers-warn-doctors-are-scamming-patients-with-fake-stem-cell-claims
Equally egregious are the in your face, regularly appearing ads in our newspapers for stem cell treatment via amniotic fluid. If there were viable stem cells in amniotic fluid, the non-autologous (yours to you) nature of said treatment is contrary to FDA compliance. On the other hand, repeated microscopic studies confirm that no viable stem cells are to be found in amniotic fluid once recovered by amniocentesis, sterilization, processing, freezing and eventually fast thawing for injection.
I will attempt to respond to the “Climate of Confusion” critique found as a headline inside the article. Rather than repeat the lengthy text, I assume I have piqued your curiosity and you will buy the periodical and read. While it is true that I use patient testimonials to promote my interventions, what I do in my practice is indeed based on an increasing data base of clinical outcomes. We practice evidence based cellular orthopedics as a result of the largest and longest running outcomes documentation data base in regenerative medicine. On February 15, at the Interventional Orthopedics Foundation annual meeting taking place outside of Boulder, Colorado, my colleague David Karli will report on my outcomes at one year using a combined intra-articular (into the joint) and intra-osseous (into the bone adjacent to the joint) at one year and comparing the outcomes to those documented at one year following intra-articular injection alone. Patients who received the combined intervention reported an 89% average diminution of pain at one year as compared to a 40% decrease in those who underwent intra-articular Bone Marrow Concentrate intervention alone. This is one example of what may be gleaned from a data base.
In conclusion, the obvious question becomes, “How to Protect Yourself” from unscrupulous stem cell therapy? My response, call and schedule an appointment or view my website and webinar:
312-475-1893
www.Ilcellulartherapy.com
I will answer your questions, avoid hype and review the fine print with you.
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
Nov 9, 2017
The other day, I noted a www.Ilcellulartherapy.com (my web site) request from a patient seeking to schedule an appointment at my office. That phone call had been placed ten days earlier and my assistants failed to respond in a timely manner. When eventually returned, the potential patient indicated that she had decided to seek consultation elsewhere. I can understand her frustration and yet would her orthopedic needs have been better served by placing a second request? I share this with you and admit we are human; as hard as we try in achieving 100% patient satisfaction, at times the system doesn’t operate as intended. The ultimate question is where to seek Cellular Orthopedic consultation and treatment even if initially, the response is not as either side would like?
For almost five years of a Cellular Orthopedic, Regenerative Medicine practice, I have integrated patient care with clinical research. This is my contribution to the evolving discipline of Stem Cell therapy for arthritis; and is based on what I introduced into orthopedic surgery during my 37-year academic joint replacement career. It is only by monitoring outcomes that we continue to learn and improve results.
Listed below are my clinical research endeavors over the past five years and the basis for my clinical recommendations:
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)
6) A Lyophilized Amniotic Fluid Clinical Trial for Grades 2 and 3 Knee OA (supported by MiMedx) Ongoing
7) An Amniotic Fluid Cryopreserved Clinical Trial for Grades 2 and 3 Knee OA in 30 patients. (supported by MiMedx)
8) An Amniotic Fluid Cryopreserved Clinical Trial for Grades 2 and 3 Knee OA in 45 patients. (sponsored by Liventa)
We Have The Evidences for Cellular Orthopedics; ask the camp followers to show you theirs.
To schedule an office visit call 312 475 1893 and please be patient.
Tags: cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, regenerative medicine, stem cell treatment, stem cells, Subchondroplasty
Nov 3, 2017
“____ and I are doing well. Mitch administered stem cell therapy on my non-operative hip and things feel great. First time I’ve been pain free in 10 years. Can’t wait for ski season” “Mine are doing great”. This second quote from the mutual friend who is patient getting ready for the ski season who recently underwent a concentrated platelet rich plasma “tune up” in anticipation.
The above quotes are from a husband and wife who underwent stem cell intervention and the second is taken from an e-mail forwarded from the mutual friend who had initially referred the couple to me. Three years ago, the wife had been referred for the limitations in her knee produced by post traumatic arthritic progression. She and her husband were avid ski enthusiasts but the patient could not plan for an upcoming helicopter skiing that winter in western Canada, owing to limitations imposed by arthritis. In the fall of the year, I completed a Bone Marrow Concentrate intervention into her right knee and she returned to Heliskiing. Earlier this summer, the husband elected to undergo a right hip intervention so he might continue at the highest level of recreational skiing. According to his report, there is patient satisfaction from both sides.
Yet, I still strive to improve outcomes and patient satisfaction with the duration of effect. In order to improve results, benefit, and extend the success, I introduced the intraosseous alternative into my treatment protocol when deemed indicated. If the preoperative imaging is compatible with the potential to improve the end result by a subchondroplasty, as I did for a patient this past Wednesday, not only will Bone Marrow Concentrate be injected into the joint, a biologic implant will be injected into the bone adjacent to the joint. The additional procedure adds nothing to the cost of care nor does it require any alteration in the postoperative rehabilitation process. I have requested precertification to determine if indemnification will cover the intraosseous injection of the biologic implant.
On a scientific basis is the fact that it is the subchondral bone that supports the cartilage lining the joint surface. If there is an insufficiency or fragility of subchondral bone, the cartilage will eventually fail. It has been suggested that the pain of arthritis may be the result of alterations in the subchondral bone in addition to inflammation within the joint. Please remember that there are no nerves in cartilage.
To determine if you are a candidate for postponing or avoiding a Joint replacement for the pain and limited function attributable to arthritis and what treatment alternative will result in the most satisfactory and longest lasting end result, call for a consultation
Call (312)475 -893 or visit my web site and watch the webinar: www.ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, cellular orthopedics, Concentrated Stem Cell Plasma, Interventional Orthopedics, stem cell treatment, stem cells, Subchondroplasty
