“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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Evidence Based Medicine and Looking Back at 2016 Interventional Orthopedics

Evidence Based Medicine and Looking Back at 2016 Interventional Orthopedics

I use bone marrow derived stem cells because they have been proven to be most effective at treating orthopedic conditions when compared to adipose derived stem cells.  There have been 13 papers published showing bone marrow superiority to adipose tissue in regards to treating orthopedic conditions and to the best of my knowledge, none reporting adipose derived results for arthritis. In addition to Adult Mesenchymal Stem Cells, bone marrow has 1,000-10,000x more hematopoietic stem cells than adipose tissue; the former is necessary for muscle repair. Recently, we learned that bone marrow also has osteochondral reticular cells which are not found in adipose tissue and serve as orthopedic repair cells.  While adipose tissue and bone marrow both have stem cells, the skeletomuscular specific cells only found in bone marrow make it the best at treating orthopedic conditions. I don’t have a stake in doing bone marrow derived stem cells, I practice evidence based medicine and do what’s been shown to provide the best results.  If with continued research something superior to bone marrow derived stem cells becomes available, then I will gladly adopt that protocol.  

http://www.regenexx.com/fat-vs-bone-marrow-stem-cell-video/

  • As I have reported on this Blog many times, research has shown the amniotic fluid samples being marketed as having stem cells actually do not have any viable stem cells when received and viewed in the laboratory. I do use amniotic fluid concentrate from time to time for its concentrated hyaluronic acid effect.

http://www.regenexx.com/amniotic-stem-cells-great-deception/

  • Since we manually process bone marrow when aspirated, I am able to customize PRP which we call SCP or super concentrated platelets.  The ubiquitous beside centrifuge only has one setting for volume and concentration so those using this approach are treating every patient without concern for individual differences. With the addition of the Abbott Ruby Hemocytometer, I am able to customize the treatment of the individual patient.  We can concentrate our SCP from 3-40X over baseline-with or without red or white blood cells. From my outcomes data base, I know what volume and concentration works best for treating the various body parts.  
  • We’ve developed HD BMC or high dose bone marrow concentrate which is far superior to that produced with bedside centrifuges used by most claiming expertise in Regenerative Medicine
  • I perform BMAs in compliance with the peer-reviewed literature recommendations as well as in keeping with my internal best practices research to maximize MSC yield. As stated, I count cells and know the quality in addition to the quantity of the injectate. Most doctors don’t count cells and have no idea what dose they are giving their patients

 

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Subchondroplasty Revisited

Subchondroplasty Revisited

In the late summer of 2015, I was featured on a Fox cable news segment featuring a patient on whom I had performed a Bone Marrow Aspirate Concentrate –Stem Cell intervention coupled with a subchondroplasty procedure. The patient had experienced a poor result from a right Total Knee Replacement years earlier and was seeking a means of improving function and minimizing her left knee pain resulting from arthritis. Cartilage does not have a nerve supply so scientists and clinicians have long sought a clear understanding of the pain generator in osteoarthritis. While there still is not a clear-cut consensus, many clinicians are looking at the bone marrow lesions seen on an MRI when taken of an arthritic joint as the possible cause of pain associated with arthritis.

In the case of my patient, the combined BMAC-Stem Cell procedure coupled with the subchondroplasty had resulted in a very satisfactory outcome and such maintains at this time to the best of my knowledge. What was unique about my patient was the use of Bone Marrow Concentrate-Stem Cells to serve as the catalyst to effect healing of the bone marrow lesions. Up until that time, surgeons were using a synthetic calcium phosphate material to fill the defects above and below a joint surface with a mandatory three months of protected weight bearing and six months of altered physical activity. The introduction of Bone Marrow Concentrate with Stem cells required 48 hours of crutch support and six weeks of restricted physical activity.

My patient who received media attention served to foster a debate in the medical device industry as to the superior methodology serving as an adjunct to a subchondroplasty. First came the initial trial using a subchondroplasty procedure and synthetic filler with the inherent need for prolonged altered function and assisted ambulation. Now there are several clinical trials in development pertaining to an arthritic joint and the minimally invasive, percutaneous subchondroplasty comparing the synthetic filler to the Bone Marrow Aspirate Concentrate-stem cell adjunct; with the latter used both inside the joint and in the adjacent subchondral bone.

Are your arthritic joint changes affecting both the cartilage and the supporting bone? Is the actual source of your joint pain, the supporting bone or bone marrow lesions adjacent to the hip, knee, ankle or shoulder? It would require a complete examination and review of X-rays and an MRI for me to answer the question and advance the most appropriate therapeutic recommendation. Could it be that the failure of a regenerative intervention wasn’t a failure of the stem cells but rather a failure to address the real pain generator, subchondral bone?

Call for an assessment 312 475 1893 and I will try to answer that question.

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“Exercise linked to reduced risk of several cancers”

“Exercise linked to reduced risk of several cancers”

From the AMA Morning Rounds May 16, 2016
Today’s Medical News Prepared Exclusively for You

Leading News
“Exercise linked to reduced risk of several cancers”

ABC World News Tonight (5/16, story 11, 0:25, Muir) reported, “The
National Cancer Institute confirms that moderate exercise, all the way
up to intense exercise, lowers the risk of” cancer “in many forms.”
The Los Angeles Times (5/16, Healy) reports that the research,
published in JAMA Internal Medicine, suggests, “exercise is a powerful
cancer-preventive.” Investigators found that “physical activity worked
to drive down rates of a broad array of cancers even among smokers,
former smokers, and the overweight and obese.”

US News & World Report (5/16, Esposito) reports that
investigators “analyzed data from participants in 12 US and European
study groups who self-reported their physical activity between 1987
and 2004.” The researchers “looked at the incidence of 26 kinds of
cancer occurring in the study follow-up period, which lasted 11 years
on average.” The data indicated that “overall, a higher level of activity
was tied to a 7 percent lower risk of developing any type of cancer.”

TIME (5/16, Park) reports that “the reduced risk was especially
striking for 13 types of cancers.” Individuals “who were more active
had on average a 20% lower risk of cancers of the esophagus, lung,
kidney, stomach, endometrium and others compared with people who
were less active.” Meanwhile, “the reduction was slightly lower for
colon, bladder, and breast cancers.”

Historically, I have directed my Blog to fitness, improved activities of
daily living, and recreational endeavors. The Leading News report
quoted above introduces an additional goal. Considering the significant
progress in research and management of different cancer types, after
mesothelioma explained, I am not going to suggest
that you will prevent cancer by undergoing a cellular orthopedic
intervention to an arthritic hip or knee; but, I am introducing the
concept that by my improving your activity level and functional
potential with a cellular orthopedic intervention for the symptoms of an
arthritic hip or knee, I will improve your exercise capacity and your
exercise tolerance with the inferred inherent health care benefits be it
cancer prevention, heart health, etc.

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Looking back on the pain of arthritis, Nah; Let’s look forward to pain relief with Stem Cells

Looking back on the pain of arthritis, Nah; Let’s look forward to pain relief with Stem Cells

The holiday season is here and along with it, the customary retrospectives and predictions. Here in Chicago, we could look back at the weather a week ago or look forward to the opening of the Western ski resorts and the new opening date of trout fishing in Wisconsin’s Driftless area on January 2nd. For those who want to cycle through the winter, the choice is spin class or the new world of winter friendly bikes. Whatever your interest, be it indoors or outdoors, you need not be limited by arthritis. The new world of Regenerative Medicine and Interventional Orthopedics offers pain relief, improved function, better motion and a maintenance or return to an active life style. Vail opened on November 20, and my wife and I will soon be there for a tune up. Over the Thanksgiving weekend, I will be shopping for the winterized bike and we are scheduling a fly fishing outing to Wisconsin sometime during the first two weeks in January. While it seems strange to think of trout fishing in the winter, the notion of a reason for a snowshoe hike is new and stimulating.

Last week, along with the follow-ups and new patients, two individuals exemplify what Bone Marrow Aspirate Concentrate/ Stem Cell interventions make possible. A 67 year old man with an osteoarthritic knee works in heating and air conditioning; wherein as part of his job description, he climbs ladders while occasionally squatting and kneeling.  While he plans to retire at age 70, he doesn’t want to take on the risk of a knee replacement adverse outcome now nor does he want to take up to three months post operative for rehabilitation. After my evaluation and review of images, he elected to schedule an Orthopedic Cellular intervention with the plan to return to a minimum demand work profile for four to six weeks following the intervention; but only one week away from work. The patient is aware he may still come to a joint replacement; but if he does, it would be well after retirement.

The second patient was a 70 year old man, who had been scheduled for a shoulder replacement and a hip replacement.  The appointment was really for his wife; but while he was in the office, after hearing my informed consent for his wife’s knee; he requested my input after examining him and reviewing the fact that he didn’t want to lose a winter of skiing. When all was said and done, he scheduled a Bone Marrow Aspirate Concentrate/ Stem Cell intervention to his shoulder and hip, cancelled his hip and shoulder replacements, and booked his winter travel to Beaver Creek.

The above are examples of what is possible with Interventional Orthopedics. Before closing with a customary wish for a Happy Thanksgiving, let me share how I have been regenerated by a knee intervention. In anticipation of a full house over the holidays, I spent three hours, Saturday afternoon on my hands and knees scrubbing the kitchen floor with a microfiber cloth and a 10% solution of vinegar.

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When Aging Athletes Wait Too Long to Hang It Up

When Aging Athletes Wait Too Long to Hang It Up

The PERSPECTIVE section of the Chicago Tribune / Wednesday, February 11, 2015 ran the headline and an article written by Gerald D Skoning. It was well thought out, I have kept the page on my desk since February thinking that this was a marvelous subject for me to Blog about and how to possibly extend the career of injured or aging athletes, be they amateur or professional.

I am surrounded by several good friends who want to continue skiing, cycling, wadding up a stream with fly rod in hand, or spend an hour each day in the health club. Unfortunately, most of my contemporaries in their sixties and seventies have hung up their athletic gear but maybe it isn’t too late for you. An athlete doesn’t have to win but you might still enjoy competing and participating. Our mission statement is our ethos. Mary, the research coordinator and physical therapist in our office wore her medal to work on Tuesday earned as a cycling participant in the Co-Ed relay division of the Chicago Triathlon two weekends ago. I have recently returned from a week of cycling and fly fishing in Southwest Wisconsin. I am not injury free nor have I avoided the effects of arthritis after a lifetime of athletic participation. When the time came where I was surrounded by “ I am just a used to be”; I opted for a cellular orthopedic intervention to my left knee and here I am. Grit and determination can prolong your recreational and athletic enjoyment; so can Orthobiologics. Our regenerative offerings contain an enhanced profile of ant-inflammatory cytokines, anabolic growth factors, and adult mesenchymal stem cells. Our data clearly documents improved function of the knee. With the introduction of Subchondroplasty, we hope to do even better. Whereas our initial hip outcomes did not compare to those of the knee, the several patients who returned for a second procedure are doing extremely well. Now I am happy to note that patients presenting with arthritic shoulders and ankles are very improved from our interventions,

You must decide if you want to be a “still” or “used to be”. When four of us rode up and down the hills of the Driftless Area two weeks ago for hours at a time, you couldn’t match that camaraderie. I did the same four weeks earlier with my wife and two sons; the time has not come and I won’t quit because the next orthobiologic intervention for the other knee is waiting.

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