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 312-475-1893 for details. Click here to learn more.
Scientific Evidence Supporting Cellular Orthopedic Recommendations

Scientific Evidence Supporting Cellular Orthopedic Recommendations

In my last blog, I used anecdote and two patient experiences to justify my treatment recommendations.  This blog will feature a scientific and statistically significant outcomes study that I will be presenting next week at the Orthobiologic Institute Symposium (TOBI) taking place virtually in Las Vegas, Nevada. Since I am the first author of the study, I will claim an author’s license to paraphrase and attempt to simplify.

Cellular Orthopedic Recommendations

Knee osteoarthritis (OA) increasingly is considered to be a whole-joint disease, of which degeneration of the articular cartilage is a critical component of OA pathology, along with alterations to the synovial membrane and changes to the subchondral bone supporting the cartilage. Compounding the treatment of OA is the slow and usually limited recovery of damaged articular cartilage. Conventional therapies, including viscosupplementation, steroids, physical therapy, and non-steroidal anti-inflammatory agents, have shown some benefit in reducing OA-associated knee pain, and improving quality of life/functionality, at least for some period of time, but lack evidence of regenerative or long-lasting benefits. Orthobiologics such as Platelet-rich Plasma (PRP) and Bone Marrow Concentrate (BMC) also have been used in treating OA, with variable degrees of success. Although most publications concerning treatment of knee OA use an intraarticular (into the joint) route of injection, there are a few recent publications that have described an intraosseous (into the bone adjacent to the joint) route for injecting an orthobiologic.

The current study was structured to assess the safety and potential therapeutic benefit of treating patients with mild to moderate knee osteoarthritis with a split injection of BMC, such that approximately 80% of the injectate was delivered intraosseous to the tibial plateau, and 20% was delivered intraarticular. Each BMC preparation was analyzed for Total Nucleated Cells (TNC), and culture-based Stem Cells.  Clinical outcomes were recorded for the Knee Society Score; Lower Extremity Functional -activity-Scale (LEFS); and Visual Analog Scale-pain- (VAS). We also assessed for correlations with patient factors, including cellularity (Total Nucleated Cells) and Stem Cells) and pre-treatment clinical outcome values.

The results reported in this study demonstrate the safety of intraosseous delivery of BMC to treat mild-moderate knee OA. Equally important, study participants reported a mean change in VAS (pain scale) at the 1-year milestone of -2.6, which is slightly larger than the commonly reported VAS of -2.5, suggesting that the treatment protocol resulted in a meaningful decrease in pain out to 1-year post-treatment. The mean change at 1-year of the LEFS (activity) outcome was +15.8 points, which is 2.3x larger than that commonly for LEFS of 9 points, while marked improvements in KSS-Knee and KSS-Function also were observed.

I understand that which I have attempted to explain may be confusing but the results of this trial should be understood. For clarification, call and schedule a consultation (847) 390-7666. You may visit my website and watch a webinar at www.sheinkopmd.com

Tags: , , , ,

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

FDA Warns About Stem Cell Therapies

Some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. September,2017

FDA News Release

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy. January, 2019 

New Google policy bars ads for unproven stem cell therapies

Untested, deceptive treatments” can endanger consumers, Internet giant says.” October,2019

Discover the Science and Potential of Exosomes!

Visit the world’s largest exosome production, research and development facility at Kimera Labs, located in Miramar, FL, where world-leading exosome scientists and physicians will present exosomes educational sessions featuring the latest developments in exosome science and clinical research.

In spite of the attempts at consumer and patient protection by the FDA and Google, the bad actors and charlatans are still out there as evidenced by the following e-mail blast I received last week:

How do I explain the continued disregard at attempts by the FDA to protect the patient? The bad actors have been inspired by models of greed and unhinged marketing. But the FDA and potentially the FTC will get to them. The FDA didn’t issue a Public Safety Notice explicitly mentioning exosomes for nothing.  Also, state medical boards are enabled by statements from the FDA that exosomes are experimental drugs, and physicians aren’t supposed to experiment in their patients.

Evidence Based Medicine is the new era of Regenerative Medicine and Cellular Orthopedics

Clinical outcomes and safety of a combined autologous bone marrow concentrate intraossesous and intraarticular injection for knee osteoarthritis at 12 months.  Sheinkop, et al 02/01/2020

A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2-year follow-up. Sheinkop, et al 12/2018

Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees. Sheinkop, et al 11/2018

My Current Clinical Practice

Acellular Growth Factors

Proprietary Platelet Rich Plasma and Fluid Concentrate

This is what I had done at both hips and both knees in December; and I am going skiing in Vail two week from now

Bone marrow Concentrate

Visit www.sheinkopmd.com

Adipose Based Stem Cells

Visit www.personalizedstemcells.com to learn more

To schedule a consultation, call (312) 475-1893. The field of Cellular Orthopedics is dynamic and the associated costs are also changing to increase patient opportunity.

Tags: , , ,

Is it the stem cells or the growth factors?

The New York Times: 2019/05/13 “Stem cell Treatments Flourish with Little Evidence That They Work”

Several years ago, I asked a question of a cellular biologist as to how is Bone Marrow Concentrate effective if the number of adult mesenchymal stem cells diminish as we age? His response: “Bone Marrow contains lots of things including stem cells and proteins called cytokines or growth factors. It may be that the growth factors are most important in joint restoration and blocking pain.”

Let’s take for example, inflammatory arthritis such as Rheumatoid and Psoriatic arthritis. The common denominator is a pro-inflammatory cytokine called Tissue Necrosis Factor found in the body’s immune system.  The growth factor, TNF-alpha blocker is now used to control the inflammation and alter the body’s immune response to the proinflammatory protein. As a result of TNF-alpha blockers, Phil Mickelson is a very competitive golf professional, (You have seen him as a spokes person for Psoriatic Arthritis treatment with Humira). Since the introduction of TNF alpha blockers in Scandinavia five years ago, there has been a 40% reduction in Total Knee Replacements for inflammatory arthritis. When Kobe Bryant traveled to Dusseldorf, Germany almost nine years ago, he received treatment for a very arthritic knee with Interleukin -1 Receptor Antagonist Protein, along with other blockers. Shortly thereafter, he returned to play another five years in the NBA. The IRAP that Bryant received was and is an anti-inflammatory, a growth factor blocker, a cytokine.

As I agree in part with the  criticism in the New York Times concerning Stem Cells, those who read this Blog will recall that I don’t “sell” stem cells. Bone Marrow is used in part because of the fact that it contains stem cells; but more importantly as we age, Bone Marrow contains Growth Factors, the anti-inflammatory protein Cytokines that restore a joint by minimizing pain and improving function. Over the last eight years, we have accumulated the evidence that Bone Marrow Concentrate works for arthritis via stem cells, growth factors, or all of the above. Recently we have taken a major step forward by filtering high concentrations of Growth Factors from the Platelet Poor Plasma, previously discarded, that remained after we centrifuge the bone marrow and add the filtrate to that which is injected into the painful joint. Stem Cells maybe, highly concentrated Growth Factors that act to block pain and improve function, for certain.

You may learn more by visiting my web site at www.sheinkopmd.com  or call for a consultation (847)390-7666

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

Masterful Care of The Aging Athlete

I consider myself an aging athlete who still skis, cycles, dedicates five days a week to fitness, plans to soon plant a garden, and walks up a spring creek with a fly rod. When my arthritic hips and knees began to limit my recreational profile several years ago, I chose the regenerative medicine option rather than joint replacements. Having performed joint replacements for 37 years and studied the benefits and limitations of such, I elected to postpone, perhaps avoid major surgery with the inherent risks and limitations. First it was Platelet rich plasma, next came PRP with Growth factor Proteins; and next came stem cells. At the get go, I did not expect to regenerate cartilage; but I did hope to restore joint function, minimize pain, and maintain the highest possible activity potential. Even with Grade 4 osteoarthritis of my major joints, I can report that I skied for a week in Vail this past February as I did a year ago, recently spent three days wading though spring creeks in Southwestern Wisconsin with a fly rod in pursuit of trout, and cycled 30 miles last Saturday. I am not alone as my biking, skiing and cycling buddy with similar knee issues returned last week from his yearly helicopter skiing adventure. I have been managing his knee arthritic issues with regenerative medicine interventions for over five years.

Then there are the athletes in their 50s. Certainly, the option is there for a joint replacement for a grade three arthritic joint but what If? What if there is a complication, an adverse event, a failure to regain motion, or residual pain? The fall back potion after a failed joint replacement is another joint replacement and the outcomes of revision surgery are frequently not satisfactory. Several weeks ago, I described the recreational pursuits of a 58-year-old volleyball enthusiast who had initially considered a joint replacement when 15 years after an arthroscopic partial meniscectomy, the predictable post traumatic arthritis had forced him to suspend his activities. He chose a regenerative medicine stem cell option; and eight weeks thereafter, he is back to playing volleyball three times a week. While on occasion, a booster follow-up injection is needed; we are in the process of developing a manuscript for scientific publication focusing on the successful outcomes of 20 patients followed for one to two years after a combined injection of bone marrow concentrate containing stem cells into the knee and the bone adjacent to the knee. These are recreational athletes between ages 45 and 60 who won’t quit.

On May 4, I am one of three invited faculty to present at The Regenerative Medicine Training Institute (RMTI). On June 7 and 8, I have been asked to participate in the Workshop and Lab Faculty at the largest Regenerative Medicine program in North America (TOBI). Owing to our integration of patient care with scientific outcomes monitoring, we have been able and continue to provide masterful and evidence-based care to aging athletes. To continue to remain in the forefront of Regenerative Medicine, I dedicate a good deal of time reviewing the future while monitoring the outcomes of patient care. Several new treatment options are soon to be launched including expanding my scope of care to those with inflammatory arthritis.

To learn more, call for a consultation (312) 475-1893. You may visit my website: www.sheinkopmd.com

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

Should All Meniscal Injuries Undergo Operative Treatment ?

Should All Meniscal Injuries Undergo Operative Treatment ?

A patient presents to the office because of pain in the knee with or without a history of injury. An examination is performed followed by an X-Ray. Osteoarthritis may or may not be seen on the X-ray. If there is an altered range of knee motion when compared to the “normal” side, then a preexisting condition is considered. Whether or not the physician considers arthritis, an MRI is requested. The MRI report 48 hours after imaging is consistent with a torn medial meniscus. Should all patients with a torn medial meniscus undergo surgical intervention? If surgery is undertaken, should the procedure be a repair or a partial removal? The management of meniscal injuries must be influenced by the knowledge that meniscal integrity is important in load distribution across the joint. Meniscal injury causes altered joint mechanics and is related to the onset of arthritis.

According to a recently published online article in the British Journal of Sports Medicine, arthroscopic partial meniscectomy (APM) may not be the best option for all patients with knee pain and meniscal tear. Researchers investigated patients with meniscal tears that compared Arthroscopic Partial Meniscectomy to nonsurgical intervention, pharmacological intervention, and no intervention. At six to 12 months, APM patients had a slight improvement in knee pain, knee-specific quality of life, and knee function compared to physiotherapy patients. When excluding osteoarthritis (OA) patients, the aforementioned outcomes exhibited small to moderate improvement. Knee pain, function, and quality of life did not improve for APM patients compared to placebo surgery patients at six to 12 months regardless of OA status.

There may, however, be a small-to-moderate benefit from APM compared with physiotherapy for patients without osteoarthritis and who have mechanical or obstructive signs. Arthroscopic partial meniscectomy (APM), a keyhole surgery where loose and fragmented pieces of a torn meniscus is removed, is one of the most common orthopedic procedures performed. Over half of these are performed to treat a meniscus tear in a degenerative knee; however, several recent randomized trials have shown that Arthroscopic Partial Meniscectomy is not superior to conservative treatment or placebo treating meniscus tears associated with a degenerative knee. On the other hand, there is universal agreement that the traumatic meniscus tear, the result of a knee injury in a younger patient with otherwise healthy knee (with no degeneration), should be treated by surgery.

Then what is the downside of meniscal injury and surgery? The medial and lateral meniscus together provide shock absorption, establish a broad base of contact surface and help provide stability to the knee. Those who have undergone total or partial meniscectomy should understand that in five to 15 years, they will develop degenerative arthritis. The long-term outcomes of those whose tears were treated by repair rather than removal has not been established. My Regenerative Medicine practice in part, is the result of those seeking to postpone or avoid a Total Knee Replacement years after a meniscal injury followed by arthroscopic surgery. As long as the arthritis has not progressed to a Grade 4, I am able to assist the patient with joint restoration, at times joint regeneration, it is matter of age and health. While I am able to offer joint restoration, on occasion, joint restoration for those who sustained meniscal and Anterior Cruciate injury in the past, is there anything that could be used as an adjunct at the time of the meniscal injury to promote healing without surgery or postpone, perhaps avoid future postraumatic arthritis?

To learn more. Schedule a consultation (312) 475-1893.You may view my web site at www.sheinkopmd.com.

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

Pin It on Pinterest