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.
All Stem Cell Procedures are not the same

All Stem Cell Procedures are not the same

Last week, a patient called and cancelled her scheduled Bone Marrow Concentrate Regenexx SD Stem cell procedure declaring that she had found a less expensive provider for stem cells. I wished her well and devoted some time to trying to better understand the price range posted on the internet for the Regenexx SD procedure. While I couldn’t really get a grasp on the geographic differences in costs, I did realize the chaos and confusion potential of trying to compare apples and oranges. The Regenexx SD Stem cell procedure is the gold standard in the emerging world of Cellular Orthopedics (Regenerative Medicine). There is a seven year outcomes data base supporting the safety and efficacy of the Regenexx methodology. We have been monitoring the successful outcomes of our procedures for a longer time and with the most detailed, reproducible criteria in the field. If you look at non Regenexx websites, you frequently find our outcomes data reproduced (many times without permission).

The Regenexx mission statement is to get the patient back to things he or she loves faster and without surgery. The actual preparation for the procedure, the harvesting and processing of the bone marrow and the follow up management is proprietary in nature; that’s why price shopping doesn’t work. If it isn’t a Regenexx SD procedure, it is a generic knockoff and you will really minimize the chance of success. There are several Regenerative Medicine practices outside of Regenexx in the Midwest; yesterday, a patient called to schedule a Regenexx SD procedure after having gone elsewhere for less cost and experienced the anticipated unsatisfactory outcome.

This is not cookie cutter technology. The harvesting of the bone marrow cannot be from a single site or you risk a marked diminution in the number of adult mesenchymal stem cells harvested. The amount of bone marrow harvested must meet the quantitative requirements for maximum benefit. The simple recovery of 10 ccs of bone marrow is doomed to fail yet the latter is frequent in some settings so as to minimize charges. Then there is the proprietary system of concentrating and processing only available through Regenexx. Last of all, the counting of cells is not a futile exercise as suggested by the “knock off” clinics. We are able to sense success in numbers.

To determine if you are a candidate for stem cell management of your arthritis, you need to make an appointment. A telephone interview doesn’t do it nor does my looking at your images. The determinant is based on my intake and my experience. There are patients whose needs are better served by a joint replacement. If you do meet the inclusion criteria for management for your arthritis with stem cells, there is no better alternative than the Regenexx SD intervention

312 475 1893 to schedule an appointment.

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All Stem Cell Procedures are not the same

Who with osteoarthritis may benefit from Regenerative Medicine?

First of all, let me expand on the concept of Regenerative Medicine at times also understood as Cellular Orthopedics or Stem Cell therapy. Cells with stem cell properties are present in bone marrow, the peripheral circulatory system, adipose tissue, synovial tissue, muscle tissue, and tendon. At this time, the FDA allows point-of-care bone marrow aspirate intervention for arthritis. From a clinical standpoint, the stem cell concentrate of bone marrow aspirate is technique-dependent and I have found it to be an ever increasingly important factor of therapeutic benefit. When it comes to Adipose-Derived Stem cells, use of these products places risk upon the clinician and the patient because they do not meet the criteria of homologous use and are not autologous. Enter the latest interest in amniotic fluid concentrate with all the marketing hype. As of this time, to the best of my knowledge, there is no clinical outcomes science to justify such use. I should know as I am the Principal Investigator in the largest Clinical Trial involving amniotic fluid for arthritis ever undertaken.

Next, the reader should understand that Osteoarthritis is graded, not all OA is the same. To qualify for a Regenerative Medicine procedure, the degree of arthritis must not exceed grade three based on Imaging and Physical Examination. The standard grading system is termed the Kellgren-Lawrence Scale in which the X-ray image is scored. The physical examination is also taken into account to confirm that the extent of degenerative deformity has not exceeded inclusion criteria.

Now let me explain how Stem Cell intervention is accomplished in my setting, who may benefit, and when Regenerative Medicine is not a reasonable option. Actually if you watch my Webinar,

https://sheinkopmd.com/webinar/

you will better understand.

What are a patient’s options when a first intervention isn’t long lasting? Assume if you will that you have not realized the outcome that would be satisfying to you and rewarding to your interventional orthopedic specialist; there are two options:

Repeat Stem Cell Procedure

I have had at least ten patients in my practice who ultimately reached their goals after a repeat Bone marrow stem cell intervention

Joint Replacement

While it is a procedure that we seek to postpone, perhaps even avoid with a Regenerative Medicine intervention, stem cell procedures do not burn bridges

After watching my webinar, to learn more or schedule an appointment call   312 475 1893

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All Stem Cell Procedures are not the same

I produced a Cellular Orthopedic webinar

You may be the first to see the preview

A web-i-nar according to the dictionary, is a seminar that takes place over the internet.

Dr. Sheinkop’s Webinar on Regenerative Medicine 

While not yet ready for prime time, it will go live in 45 days, but readers of this Blog may view it now by clicking the above. My purpose in creating this educational endeavor is and was to better inform the prospective patient as to the scope of my regenerative practice, to allow the new patient to become better informed, and to facilitate review of the informed consent process should you chose to avail yourself of my services. The webinar plays for about 30 minutes but you don’t have to watch it all in a single session. One of the advantages of this form of communication is watching at your own convenience plus the option to return as you chose.

In planning and editing this undertaking, I took into account that which I have experienced over a four year plus regenerative medicine practice emphasizing and repeating wherever I deemed appropriate. The majority of the patients I treat present with grades two and three osteoarthritis of one or two joints. Of over a thousand I have treated, the majority have received Bone Marrow Concentrate/Stem Cell approach. For those who present in an earlier stage of osteoarthritis no longer responding to cortisone and hyaluronic acid, I do explain the Multicenter Amniotic Fluid Concentrate Clinical Trial for which I am the Principal Investigator. By the same token, for those patients who have advanced arthritic changes, that is grade four, and who otherwise would require a total joint replacement, I cover cellular orthopedic options as well although not necessarily bone marrow derived. One major possibility in the webinar format once accessed through the internet will be the opportunity to post questions and I will do my best to respond in 24 to 48 hours. Another area of explanation is the subchondroplasty for which there continues to be increasing evidence that both intraarticular (inside the joint) and extra-articular (the bone supporting the joint) options should be employed when treating arthritis of a major joint. I want to emphasize, the main treatment on which I base my practice is Bone Marrow Concentrate containing stem cells, anti-inflammatory Cytokines and Growth Factors owing to the potential to regenerate the joint, eliminate or reduce pain and increase functional capacity while, on a molecular basis, halting, maybe reversing the arthritic process.

 

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All Stem Cell Procedures are not the same

Announcing an Amniotic Fluid Clinical Trial

As the regular readers of this Blog are aware, one way to catch my attention is to send me another announcement found in a local newspaper regarding “free” Amniotic Fluid Concentrate seminars in which the reader (victim) then learns at the seminar that he or she can receive stem cells to cure whatever ails that person for a fee ranging between $7,000 and $9,000.

Based on what is scientifically certain about Amniotic Fluid Concentrate, in spite of what you are told at these seminars by the marketing spokesperson, there are no viable stem cells once the amniotic fluid is processed, concentrated, gamma irradiated, and fast thawed for the injection. Nevertheless, the Camp Followers are saturating the media with claims of benefit for almost every malady known to mankind by paying this exorbitant sum for a single injection.  That is not to say there is not anti-inflammatory benefit and growth factor content in amniotic fluid concentrate so there is some pain relieving potential.  What is not known is the optimal dose schedule, dosage concentration, and the duration of benefit.

In order to scientifically determine how to properly use amniotic fluid concentrate in a clinical practice and statistically measure value, I have accepted the invitation from a major Ortho-biologic producer of amniotic fluid concentrate to participate in a multicenter Clinical Trial under FDA regulatory scrutiny. Our study group will determine the benefit of amniotic fluid concentrate in the arthritic knee, the proper dosage schedule, the appropriate concentration and the duration of effect.

For those who elect to partake in this Clinical Trial and who meet inclusion criteria, there is no charge for the pharmacologic agent (Amniotic Fluid Concentrate). On the contrary, the participant will be reimbursed for travel expenses. By helping us understand the benefit of Amniotic Fluid Concentrate (if any) when used for an arthritic knee and determining appropriate dosage scheduling, the Ortho-biologic industry and we clinicians will finally learn if it works; and if so, for how long and at what dosage. So you decide, either call the number appearing in the media ads and be ready to pay up to $9,000 for a stem cell intervention without living stem cells or call 312 475 1893 to learn if you meet the inclusion criteria for the Multicenter Trial.

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All Stem Cell Procedures are not the same

The explosive growth of Stem Cell interest in my practice

For those new to this Blog, my focus on Regenerative Medicine has just started its fifth year. Prior to that time, I was an orthopedic surgeon surgically replacing hips and knees at a major academic Chicago Medical center for almost 40 years. I then graduated into Regenerative Medicine where I have dedicated the past four years helping patients avoid or at least postpone when possible, a joint replacement for an arthritic hip, knee, shoulder or ankle. You may have learned from that previously written, during my joint replacement years, every patient undergoing a hip or knee replacement became part of a comprehensive database wherein by integrating research with patient care, I would continue to stay in the forefront of reconstructive orthopedics. I would present my findings at various orthopedic seminars around the world and share my knowledge with interested orthopedic surgeons so they could determine the best prostheses, the best surgical approaches, the best rehabilitation techniques, how to prepare a patient for a procedure, and how to achieve the best possible outcome both functionally and from the standpoint of survivorship of components.

When I entered the emerging discipline of Interventional Orthopedics, I introduced my knowledge of orthopedic research as well as my support team, adapting joint replacement clinical research methodology for stem cell intervention outcome surveillance. Owing to my long tenure as a clinician and my Emeritus Professorship designation, many now are seeking my advice and counsel on how to maximize outcomes from a Bone Marrow Concentrate intervention in an arthritic joint. All this being said, within the last several days, I have provided stem cell consultation to a retired professional baseball player of note, and to a medical tourist from the United Arab Emirates, where I had taught joint replacement surgery over 11 times between 2001 and 2007. Today, my office received a call requesting a consultation from a family of Turkish tourists visiting Chicago. Between 2002 and 2006, I had visited Turkish Orthopedic Centers in Izmir, Ankara and Istanbul to demonstrate hip and knee replacement procedures while also lecturing on five separate occasions by invitation around the country.

The point is that there are those of us who are qualified intellectually, experientially, and clinically to assist the patient limited by arthritis of a major joint using Evidence Based Medicine for stem cell care; while there are those who recruit patients by placing a marketing ad with unsupported claims in the media. If you want a consultation based on Best Regenerative Medicine Practices, call for that consultation:    312 475 1893

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All Stem Cell Procedures are not the same

The difference between an orthopedic surgeon and the camp followers

From the AMA News, July 1


 

Good Morning Dr. Mitchell Sheinkop.  Here are today’s top stories.

Leading the News:

Unproven stem cell therapies available at hundreds of US clinics

In “Science Now,” the Los Angeles Times (6/30, Kaplan) reports that research indicates across the US, “at least 351 businesses at 570 locations are marketing stem cell therapies that have not been fully vetted by medical researchers or blessed by the” FDA. The findings were published by Cell Stem Cell.

            On its website, NBC News (6/30, Fox) reports that the FDA “regulates some stem cell treatments and says there’s almost nothing available as a commercial product.” However, the agency “does not regulate stem cells taken from a patient and reinfused back into the patient, so long as they’re changed or manipulated.” According to NBC News, “Many of the clinics on the list offer these non-regulated types of treatments.”

            In “To Your Health,” the Washington Post (6/30, McGinley) reports that this “analysis comes as the debate over regulating stem-cell clinics is intensifying.” Although “some critics say the FDA should crack down on the industry, others say they shouldn’t face new restrictions because what they are doing is part of the ‘practice of medicine.’”

            Bloomberg News (6/30, Ramkumar) points out that “the FDA has issued draft guidelines for stem cell therapies and is planning a public hearing in September on regulating procedures.”


 

I am in 100% agreement with the AMA’s Leading News review. Yesterday, a very well known retired professional athlete sought consultation in my office concerning a regenerative intervention for his arthritic left hip. During the intake, the remote traumatic event leading to the progressive arthritic limitations could be identified. Earlier this year, we witnessed the retirement of Kobe Bryant from professional basketball and I was reminded of the stem cell procedure he underwent in Germany five years ago for a “bone on bone” arthritic knee. That interventional orthopedic procedure added five years to his career. Outcomes that we capture, as well as those of other board certified clinicians, support Bone Marrow Concentrate/Stem Cell intervention for grades two and three, sometimes grade four osteoarthritis. The 351 businesses marketing stem cell therapies for every known malady of mankind deserve an industry crack down by the FDA. I am a board certified orthopedic surgeon with outcomes and data to support my practice of improving the well being of patients afflicted by arthritis in a major joint.

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