Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.
Exciting Cellular Orthopedic Debates

Exciting Cellular Orthopedic Debates

Well, it is really an internal debate as to whether I should have a concentrated platelet rich plasma procedure or a bone marrow concentrate procedure as I get ready for the upcoming ski season. While it is true that I exercise five to six days a week rotating between outdoor cycling, strength training and rowing, the demands of skiing on the knees are such that I need to rethink my approach. I share this personal flow of conscience to provide guidance and council for readers of this blog. As for so many of us senior recreational participants, each activity has unique demands so we must anticipate each activity from a separate approach. While generalized fitness improves the quality of life and even well-being, maybe even prolonging life, if you want to ski with arthritic knees, now is the time to plan ahead.

Let me share with you my plan based on an observation of the outcomes in over 1500 patients in whom I have intervened with Cellular Orthopedic alternatives over the past five years. In the next several weeks, I will undergo a concentrated PRP intervention ultrasound guided into both of my knees. I will be using the upgraded methodologies for preparation of injectate and customize the PRP with our soon to be activated cell counter. This will provide me with a 20x dosage over that which has been available up until the present; and yes, I too have to pay for the methodology. I will then wait until mid-December, and if I am not satisfied, I will undergo a Bone Marrow Cell Concentrate procedure for both of my knees.

Below are two reasons received in the last 48 hours as to why I believe Cellular Orthopedic is exciting:

“My uber-condensed version, though, is that on almost all days in the last 8 months, I’ve had virtually no knee pain with daily activity. That’s a massive improvement from even the 12-month follow-up visit. I first started to suspect things were improving at about 10 months post-op. At 12 months, I was hopeful but still skeptical. At 14 months things, rapidly improved and have mainly remained there ever since. So, on the whole, I’m vastly improved. I suppose any number of factors could have contributed to that improvement, but Regenexx certainly seems to have helped tremendously.”

“Attended the company golf outing this past weekend. Last year I was concerned so I took an Advil before we started and ended up taking another halfway through the 18 holes. The last four holes I didn’t even leave the cart (to sore/tight to get in and out).

This year I fully intended to bring the Advil again but forgot it. Turned out I did not need it. Finished the 18 holes like nothing. Felt fine after and the next day.

Believe we can consider this a win!!!!”

Do you want to enjoy relief from arthritic symptoms and limitations?

Call 312 475 1893 to schedule a visit or visit my website to watch my webinar   www.Ilcellulartherapy.com

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“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   — 312-475-1893

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Hyaluronic Acid, Platelet Rich Plasma and Bone Marrow Concentrate

Hyaluronic Acid, Platelet Rich Plasma and Bone Marrow Concentrate

Patients receiving either Hyaluronic Acid (HA- Synvisc, Supartz, Euflexxa) or Platelet Rich Plasma (PRP) injections will experience modest-term pain relief according to an article appearing in Orthopedics Today, August, 2017. In the study reviewed, Ultrasound Guided injections were given weekly for three weeks and patient-reported outcome measures (PROMS) were recorded for up to one year. “Both the PRP and HA groups demonstrated an improvement in PROMS at 24 weeks that declined to near baseline levels at one year” according to the article. “Patients with lower grade Osteoarthritis and lower weight responded more favorably to intra-articular injections”. The effect of both Hyaluronic Acid and Platelet Rich Plasma appeared to be modest and temporary.

Why I chose this topic this week for my Blog has to do with my preparation for the upcoming talks I am invited to give September 21st and 22nd in St. Petersburg, Russia at the meeting of 1200 orthopedic surgeons from Russia, Ukraine and neighboring countries both in Europe and Asia. As I indicated last week, this will be the first time a non-operative intervention of a cellular orthopedic, regenerative nature, as I practice, will have been introduced into this region of the world. While Hyaluronic Acid and Platelet Rich Plasma may offer short term pain diminution for individuals limited in function by the symptoms of Osteoarthritis, it becomes clear by scrutinizing my data base that not only does concentrated bone marrow afford long term relief, the Mesenchymal Stem Cells and Growth Factors found in bone marrow when concentrated participate in regenerative possibility thereby delaying and perhaps even avoiding a joint replacement. My presentations will be evidence based without the false news and unsupported marketing claims ever present in the media.

What we have learned about Amniotic Fluid (AF) from my role as principal investigator in several multisite studies is that AF does have concentrated Hyaluronic Acid and therein may offer six to 12 months decrease in symptoms and increase in function, the effect is limited in duration; and with no viable stem cells in Amniotic Fluid Concentrate, there is no regenerative potential. Owing to the absence of inherent absence of stem cells and hence regenerative potential, I will not include amniotic fluid in my presentations.

As a scientific invitee, my responsibility is to introduce that for which we have scientific support and clinical evidence. If you want to gain a better understanding of Regenerative Medicine and Cellular Orthopedic and learn how you may postpone or perhaps avoid a joint replacement for the symptoms and limitations imposed by osteoarthritis, make an appointment, visit my web site and watch my webinar.

312-475-1893

www.sheinkopmd.com

www.ilcellulartherapy.com

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“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.

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What next?

You no longer will even need a physician, and I have been wasting my Blog space crusading about quality assurance; making certain your Regenerative Medicine specialist is Board Certified and willing to provide outcomes data.  According to a recent email I received, all one needs is “Online Training” to practice Regenerative Medicine:If you believe this is FDA compliant, no longer does stem cell treatment need to be done by a highly trained, highly experienced specialist; you won’t even have to use a physician.“Everything gets commoditized, including training to do stuff” (personal communication).

I believe the most effective approach is to direct a patient with joint pain to my credentials—37.5 years of joint replacement experience, Board-certified, Emeritus Professor, four and a half years of Cellular Orthopedic experience, the largest most comprehensive outcomes data base on which to base my recommendations for care, while introducing an analytical program based on a FDA-audited analytical laboratory for assessing the quality of regenerative preparations. As for the latter point, I am now working with a team using a FDA consultant to create approved text that I will post on my website, highlighting the standards I have adopted for all phases of therapy.

I hate to conclude that the current practice of interventional orthopedics and regenerative medicine ultimately comes down to how flashy the website may be or a free lunch from the camp followers.

To watch my Webinar, access www.ilCellulartherapy.com

To make an appointment, call 312 475 1893

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