Special Announcement - Now Enrolling for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for the first of its kind FDA approved stem cell clinical trial for knee arthritis. Our clinic is now enrolling patients in this trial. Contact us at 312-767-5761 for details. Click here to learn more.

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

Tags: , , , , , , , , , , , , , , , , ,

“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

The Food and Drug Administration is cracking down on “unscrupulous” clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products,” FDA Commissioner Scott Gottlieb said in a statement Monday. The FDA has taken action against clinics in California and Florida. The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for “marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements.”

The clinic is one of many around the country that claim to use stem cells derived from a person’s own fat to treat a variety of conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says. The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration. Stem-cell researchers praised the FDA’s actions.

“This is spectacular,” says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. “This is the right thing to do.”

Daley praised the FDA’s promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on “snake-oil salesmen” marketing unproven treatments.

Stem-cell research is “a major revolution in medicine. It’s bound to ultimately deliver cures,” Daley says. “But it’s so early in the field,” he adds. “Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven’t been proven to work and may be unsafe. “Others agreed “I see this is a major, positive step by the FDA,” says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics. “I’m hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell “treatments” that may not be real treatments,” Knoepfler says.

“Don’t stop now”. Say I. This Blog has been asking for FDA intervention in those settings where Amniotic Fluid is being marketed as a source of stem cell regeneration for over a year. There is only one way to be safe and not sorry:

You may access my web site   Ilcellulartherapy.com and watch my webinar Or call for an appointment   — 847-390-7666

Tags: , , , , , , , , , , , , ,

“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

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.

Tags: , , , , , , , , , , , ,

“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

STEM CELLS

My clinical practice mission is to use autologous concentrated marrow-derived mononuclear cells for the care and treatment of a joint afflicted by degenerative arthritis so as to assist a patient in postponing, perhaps avoiding a joint replacement. I then follow the patient using osteoarthritis outcome scores to measure pain control, activity improvement, and quality of life impact. The knee society score, an orthopedic surgeon’s vehicle, (KSS) also demonstrates a significant improvement of on the symptoms subscale and function subscale in most patients who undergo a Bone Marrow Concentrate procedure in my office. What about Stem Cells? Please note at the end of the first sentence and the beginning of the second, my emphasis on autologous concentrated marrow-derived mononuclear cells; not “Stem Cells”. That bone marrow concentrate is made up of Platelets, Growth Factors, and Mononucleated cells. It has been estimated that somewhere between .0017% and .034% of the mononucleated cells are actually adult mesenchymal stem cells. My point is that when you see the ads for stem cells on the many web sites, in the print media and now on outdoor advertising signs as the one I noticed on Clinton and Monroe in Chicago this past Monday, you may fall victim to marketing and not science. Chiropractors, non-board certified physicians, family practitioners and the entire realm of camp followers have embraced the exploding discipline of Regenerative Medicine. Patient beware as I point out in the next paragraph using a recently published study from the Mayo Clinic.

Many patients come to Mayo Clinic for a second opinion or diagnosis confirmation before treatment for a complex condition. In a new study, Mayo Clinic reports that as many as 88 percent of those patients go home with a new or refined diagnosis – changing their care plan and potentially their lives. Conversely, only 12 percent receive confirmation that the original diagnosis was complete and correct. Given what I have seen evolving in the field of Regenerative Medicine, I am not surprised. Few practices offering “Stem Cells” have any idea what is involved and what is in the bone marrow concentrate. Many mislead the public with a stem cell presentation using amniotic fluid product wherein it has repeatedly demonstrated there is an absence of stem cells in amniotic fluid once processed, frozen and fast thawed. What about adipose derived stem cells? For one, to liberate the stem cell from the adipocyte, there has to be a cycle of enzymatic degradation. The latter violates FDA requirements. What about platelets and growth factors in adipose derived materials? Given the relative absence of blood supply in fat, I have yet to find a scientific publication suggesting there are growth factors in adipose tissue.

The cover story in the April 2017 AARP.ORG/Bulletin is titled “How to Stop Fraud, The Ultimate Guide to Protect Yourself from Scammers and Crooks” While not directed to Regenerative Medicine, the warning applies. As suggested by the Mayo Clinic referenced article above, the best protection is a second opinion.

To schedule call: 312 475-1893
You may visit my web site at www.SheinkopMD.com
Or watch my webinar at www.ilcellulartherapy.com

Tags: , , , , , ,

“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

Exercise Prescription and Cellular Orthopedic Intervention

Aging is known to contribute to a multitude of systemic changes including those of the musculoskeletal system leading to decreased health, mobility and function. Most changes in well-being are exacerbated by inactivity. It has been scientifically documented that physical activity and exercise may slow or even reverse these deleterious effects thereby improving health, mobility and function.

In particular, ligaments, tendons and joint capsules become stiffer with age as elastic fibers decrease and cross-links between collagen fibers increase. As connective tissue surrounding the joint changes, so too does the synovial fluid within the joint making movement more difficult. Not only do changes occur within the joint, they also occur in the muscles. The loss of muscle mass and strength also known as sarcopenia, increases with age. Then there is the fatty infiltration of muscle that comes with aging and lack of use.

Recognizing the value of Bone Marrow Concentrate derived Stem Cells, Cytokines and Growth Factors in dealing with his arthritic hip when the alternative was a joint replacement, seven months ago, a 58-year-old man underwent a cellular orthopedic intervention. Over the past many months, the patient committed himself to a minimum of 30 minutes a day, five days a week at moderate intensity aerobic exercise alternating with three days a week at vigorous intensity. In addition, he partook in resistance exercise a minimum of two days a week at a moderate high intensity focusing on 10 exercises at each session targeting most major muscle groups, with 10 to 15 repetitions for each exercise performed thus adding an additional 20 to 30 minutes to the commitment. Then there are the benefits of his additional flexibility and stretching. When this individual came to me at his first visit, his stated goals were to return to a high level of recreational enjoyment with a particular interest in ball room dancing.  As of last week, he had reached those goals but he has no intention of failing to comply with his exercise prescription.

The obvious message of my Blog is to let you know I am unable to reach a desired goal without your commitment. I may introduce Stem Cells, Cytokines and Growth Factors into an arthritic joint but to reach your desired goal or delay or perhaps avoid a joint replacement, those many changes that occur with aging can be slowed and even reversed by a combination of cellular orthopedics and exercise.

If you want to learn about the evidence, schedule an appointment    312 475 1893

Tags: , , , , , , , , , , , , , , , , , , , , , ,

Pin It on Pinterest