“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

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A Cellular Orthopedic Regenerative Testimonial

A Cellular Orthopedic Regenerative Testimonial

“Haven’t spoken with you in a few months so I thought you might be interested to hear about my knees since the January injections. Things are definitely better. The most important of which is my really bad left knee doesn’t lock up when I roll over in bed. It hurt so bad that it used to wake me up. That’s completely gone. As is the swelling even after walking 18 holes of golf and riding my bike 20 miles. It’s not completely without pain though. It tightens up. But I never have any residual pain in the mornings, even after walking 10 miles and cycling 70! 

So, I just started a vegan diet. Was told by my new doctor (she’s in Chicago and does this concierge thing) that it’s anti-inflammatory and might help me get off cholesterol medicine. So far, it’s eliminating my knee pain and I’ve only been at it a week! Fingers crossed. I’ll let you know how things go. It’s not easy being vegan, but certainly easier in SF with a vegetarian wife than it would be in Chicago with a meat eater for a mate! Thanks again.” 

Earlier this week, I received this message from a patient who I have been caring for over the last 24 months. It is very rewarding to my team and me when I learn about continued improvement following the initiation of cellular orthopedic interventions as an alternative to a major joint surgical reconstruction with the inherent risks of an adverse outcome. My practice is Outcome Focused based with a serious commitment to the clinical research required to continually confirm the efficacy of our menu of services. It is important that I maintain a leadership role in advancing the clinical science of the regenerative products that I use in my practice. As I have written before and about which I am constantly reminded, the regenerative process requires time. Sometimes it requires weeks and sometimes it takes months. On occasion, it may require more than one intervention.  

The testimonial this week suggests a change in diet allowed my patient to discontinue statins with a resultant significant diminution in pain. Many patients inquire about supplements and foods that may make a difference.  In addition, I find that those who partake in athletics and fitness, also contribute to their well-being and success of a regenerative intervention.

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Postpone, perhaps avoid joint replacements

Postpone, perhaps avoid joint replacements

Last week, we traveled to Israel to celebrate the wedding of our youngest son. Israel became the destination for the event as Eric and Judith had met there while his music business was subcontracting to Coke and Judith led the International Marketing initiatives for Coke. The event took place on July 5th, at an organic farm in the outskirts of Jerusalem. In such a majestic and historical setting prior to and after the ceremony, there took place several organized tours including one of Jerusalem, another at the Dead Sea and for several, a trip to Petra. It was a relatively small group of the attendees; one in particular, a very close and long-time friend has been the subject of my Blog in years past as I described his return to skiing, biking and fly fishing following a Bone Marrow Concentrate/Growth Factor Concentrate/Stem Cell concentrate intervention. Prior to those procedures, he had been forced to give up his athletic passions for several years because of the limitations imposed by arthritis of both knees.

Above is his activity score from Monday, July 3, when Bob and his wife toured Jerusalem’s Old City including a hike on the ramparts of the wall surrounding the Christian Quarter, the stop and prayer at the Temple Mount and a shopping spree at the Arab Suk (bazaar).

What Bob represents is the potential for continued improvement over several years following a regenerative intervention, a process of which I am continually reminded as time passes and I have a longer follow up of my patients. Our mission and ethos is to help patients with arthritic joints enjoy an active life style and postpone, perhaps avoid joint replacements when arthritic impairment ensues. The documentation from the patient above is one of improving outcome as time passes. While his is an anecdote, our data base increasingly reflects similar happenings for the majority of our patients.

There are now many providers for those with arthritic impairment seeking improved function and less symptoms; and who are not candidates for a joint replacement or who do not want to undergo the major surgical undertaking. In your choice of an Interventional Cellular specialist, inquire about her or his long-term outcomes; not just “will I get a free lunch if I attend a seminar?”

To learn more, call for a consultation 847 390 7666

You may watch my webinar and learn more by visiting my website at Ilcellulartherapy.com  

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Stem Cell Claims versus Outcomes Data

Stem Cell Claims versus Outcomes Data

It is now over four years since I began the most comprehensive outcomes clinical trial ever undertaken in which Bone Marrow Concentrate was used to reduce pain, improve function, increase activities and alter the progression of osteoarthritis in a knee joint. At the start, it was generally believed that the adult mesenchymal stem cells would reproduce themselves and emerge as cartilage therein regenerating the joint. Continued scientific investigation has taught us that the adult mesenchymal stem cell acts as the conductor of a complex bio-immune process in conjunction with growth factors. One such growth factor is an endogenous polypeptide molecule, Transforming Growth Factor -Beta (TGF-). There are many other growth factors derived from the Bone Marrow Concentrate that play a role but that discussion is beyond the scope of this Blog. Additionally, be aware that Platelet-derived growth factor attracts mesenchymal stem cells and can stimulate proteoglycan production and chondrocyte proliferation. Incidentally, should you decide to seek consultation with one of the plethora of so called regenerative medical specialists populating the internet and advertising in the media, before you go, print my blog and ask them relevant questions pertaining to the science. You make be surprised to learn you as a potential regenerative consumer know more about the subject than the highly visible marketing provider.

Getting back to the clinical trial, the recruiting process of 50 patients ended two years ago and now we have two to four year of outcomes data to statistically analyze; that scientific process will be completed next week and presented at the Orthobiologic Institute meeting taking place in Las Vegas, June 8 to 10. For the first time, real outcomes data having been analyzed using the same criteria I used in my 37- year career as a joint replacement surgeon and head of a joint replacement program at a major medical center in Chicago will be presented to the regenerative medicine community. Unfortunately, I am unable to control the charlatans and camp followers who will attend the meeting and even try to use my data for their marketing. I choose to share my data as a challenge to those who seek to market and advertise stem cells for every malady known to mankind.

If you want to become better informed, you may access my website www.sheinkopmd.com.

You may watch my webinar www.ilcellulartherapy.com or call to schedule a consultation 312 475 1893.

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On Cartilage Regeneration

On Cartilage Regeneration

Last week, my associate attended a continued medical education course held in a venue near the Wisconsin-Illinois border; a site frequently used by the Stem Cell Institute of America to host amniotic fluid marketing seminars. My colleague overheard a conversation between several physical therapists touting the success of amniotic fluid in regenerating cartilage on their patients, “you can see the increased joint space on the x-ray when we see the patient in follow-up”. I have addressed the issue of the absence of viable stem cells in amniotic fluid ad-nauseam (borrowing a recently expressed symptom from the Director of the FBI) but I am continually amazed at how false news when repeated takes on a fantasy of its own. Additionally, my patients frequently ask to repeat the imaging so they might see if the cartilage is growing.
Much of the current research effort pertaining to cartilage is experimental and has to do with the MRI techniques known as T2 mapping and delayed gadolinium enhanced MRI of cartilage (dGEMRIC). In addition to MRI techniques, optical coherence tomography (OCT) may allow arthroscopic evaluation of cartilage by performing microscopic cross-sectional imaging of articular cartilage. In the final analysis, the only present clinical cost effective, non-invasive means of quantitating and qualitating the patient response to an intervention are exactly the parameters I measure in my office; the only comprehensive methodology of its kind in the clinical field of Regenerative Medicine.
When a patient asks me how do I know whether an intervention is a success, I don’t point to an increased joint space on the X-ray as it is not there to be seen. I review patient specific outcomes including pain scores, activity scores, subjective input, and objective measurements and compare the pre-intervention findings with the latest scoring.
In the interval between starting to write this Blog and now, I received an unsolicited update from a patient who had attended the Stem Cell Institute of America seminar. He had asked so many questions during the seminar, the chiropractors running the seminar gave him the PalinGen Flow brochure (their source of amniotic fluid) as my patient had challenged their evidence beyond the speakers’ ability to respond. My patient, who eventually underwent a bone marrow concentrate intervention with my assistance, read the document and learned that PalinGen Flow makes no mention of stem cell content in their literature.
To schedule an appointment call (847) 390-7666
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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

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