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 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
Oct 26, 2017
I have always wanted to incorporate a holistic component into my practice, but, hesitated because of a commitment to patients that I would limit my professional pursuits to allopathic medicine; that is evidence based cellular orthopedics. Given the increasing body of information that healthy pursuits, a fitness focused life style, and yes, supplements, may indeed impact an individual’s activity status, well-being and even longevity; I have decided to network with Nutrition Connection Balance, an individualized nutrition, supplementation and counseling practice that has the potential to optimize your stem cell health, quality and yield.
Now for my confession, I have been using nutritional supplements and pursuing a fitness based lifestyle since entering orthopedic practice some -?–?– years ago. While my genetics stacked the deck against me, the environment in which I have immersed myself has rewarded me with well-being and good health while allowing me to still partake in those recreational undertakings I enjoy at a fairly competitive level. On top of the latter, my professional pursuits keep me at the forefront of the evolving specialty of regenerative medicine. Following my presentations earlier this month to 1500 surgeons attending the Russian Orthopedic Association annual meeting in St Petersburg, Russia, I was contacted by a ballerina, a member of the Bolshoi Ballet based in Moscow. She has a knee condition keeping her from dancing and has been told the only remedy would be a stem cell intervention. Today, I received her images and will reach out later today to The Chicago based to Russian Radio 1240am to help interpret the instructions for the download of the Zip File.
Meanwhile, I digress so let’s return to Medical Nutrition Therapy. The understanding I developed with Nutrition Connection Balance is that the consult may be initiated via phone or in-office. BY calling (847) 985 1200, you will be introduced to the practices of Valerie Early RD, LDN, RPHT and Lauren Chavez RD, LDN. While the standard of web site practice seems to offer nutraceuticals for sale by physicians, chiropractors and other camp followers holding themselves out to be regenerative medicine practitioners and capable of delivering stem cells form frozen and processed amniotic fluid, I have nothing to gain financially from my endorsement other than a healthier candidate with a better chance of a successful outcome following a stem cell intervention.
If you are limited in lifestyle by arthritic or injury generated painful joints or limited function, call for a consultation 312 475 1893 or view my webinar at www.ilcelulartherapy.com. If you want to learn more about Nutrition and Supplements, call Nutrition Connection Balance 847 985 1200
Tags: arthritis, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, Orthopedic Care, regenerative medicine, stem cells
