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.
The RNA Revolution and Cellular Orthopedics

The RNA Revolution and Cellular Orthopedics

You have probably learned about RNA therapeutics over the past several years; most likely you have used this new kind of treatment as both Pfizer/BioNTech and Moderna’s COVID-19 vaccines are mRNA therapies.

RNA therapeutics is a rapidly expanding class of drugs that target pathways making personalized care a reality. They may and are revolutionizing the treatment of many ailments including arthritis. Until recently, Regenerative Medicine has been making use of Messenger RNA (mRNA) without fully understanding that Adult Mesenchymal Stem Cell and the Platelet Rich Plasma act in part through their respective mRNA content. Hence, it is the MSCs found in bone marrow (MSCs) and adipose tissue/fat (SVF) producing Extracellular Vesicles and Exosomes containing the mRNA that are responsible for effecting regeneration. They also may block and reverse the inflammation in your joints responsible for pain and altered function. The same may be said about the Platelets circulating in your blood or contained in your bone marrow. When I perform a Bone Marrow Concentrate joint injection, the benefit in part is the result of mRNA contained in Extracellular Vesicles and Exosomes produced by MSCs. The same may be said when I complete a vena puncture, concentrate the Platelets, and inject the PRP into your joints or soft tissues.

What comes next? Call (312) 475-1893 to schedule an appointment. I will perform a complete orthopedic intake with my team, evaluate your images, and make a recommendation for the treatment of your arthritic joint. Treatment option recommendations, after the intake and review of images, include four different proprietary options for generic Platelet Rich Plasma; Bone Marrow Concentrate (Stem Cells); and the Extracellular Vesicles recovered from your circulating blood that I introduced earlier in this blog. As far as the Adipose Based Stem Cell Trial (Stromal Vascular Fraction), I am anxiously waiting to learn from Personalized Stem Cells www.PersonalizedStemCells.com when the FDA will allow us to begin patient recruitment. Then there is the Collagen Allograft option for those with structural defects to their articular cartilage. Have Questions? Ask.

I gave the reader a lot to process in this blog. To clarify, visit www.sheinkopmd.com or call for that appointment (312) 475-1893.

Are We There Yet?

Are We There Yet?

With better drugs and stem-cell therapies, using these biologics, we hope to repair cartilage — or prevent damagebefore osteoarthritis sets in or an operation is needed. A sports injury or trauma to cartilage around the knee, hip, or shoulder joint can lead to osteoarthritis later in life — or, worse yet, the need for a new joint. So can the wear and tear that comes with age. It had been predicted that one day, new drugs and stem-cell therapies may stop the degeneration before it starts; that day may have arrived with timely intervention.

Update | The Next Personalized Stem Cell Clinical Trial

For those interested in the next Personalized Stem Cell Clinical Trial, I received this message on Tuesday, November 30, from the Medical Director, Personalized Stem Cells, Inc: “We met with a CRO this week and intend to have study design completed before end of year. FDA will review early next year and hope to begin enrollment soon after.” You may learn more about adipose-derived stem cells, the first PSC CP 001 Knee Arthritis Clinical Trial recently completed, and the announcement regarding patient recruitment for the next trial at www.PersonalizedStemCells.com. In response to my inquiry: “Will I be involved in the next trial?”; the Medical Director stated, “I’m counting on it.”

Extracellular Vesicles | Signal & Influence

Beyond Stem cells, Extracellular Vesicles (EVs) are the means by which Stem Cells signal and influence. The three main types of extracellular nanoparticles include 1) Microvesicles 2) Apoptotic Bodies 3) Exosomes. The three forms of EVs may be extracted from Mesenchymal Stem Cells or found circulating in your blood. At this time, the FDA does not approve the use of donor extracellular vesicles.

Is it possible that non-manipulated biologics containing the nanoparticle fraction harvested from that patient’s blood would meet the FDA guidelines for use in arthritis? Stay tuned as I am meeting with the key players next week to learn more.

Needless to say, Regenerative Medicine and Orthobiologics is a dynamic discipline, rapidly evolving. The purpose of my Blog is to keep the reader updated. To learn more, visit my website at www.sheinkopmd.com. To schedule an office visit call (312) 475-1893.

 

A Short Course on Regenerative Medicine: A Needle, Not a Knife

A Short Course on Regenerative Medicine: A Needle, Not a Knife

From your mobile device, take a look this new course, learn of the following treatment solutions to help improve the healing of fractured bones and injured muscles, tendons, and ligaments as well as stopping pain and inflammation. Below is a preview…

Wharton’s Jelly

The amount of growth factors, cytokines, hyaluronic acid, cellular components and extracellular vesicles are higher in Wharton’s Jelly compared to other biologics. These components aid in strength, flexibility, cushioning, covering, compressibility and response to friction in the body. It also plays a vital role in reducing inflammation. Derived for umbilical cord tissue, the safety and efficacy in osteoarthritis is under clinical trial and not yet FDA approved for unapproved application.

Hyaluronic Acid

Naturally present in the body, hyaluronic acid acts as a cushion and lubricant for the joints and other tissues. Hyaluronic acid can be used for various joint disorders and aging among other conditions. It may promote healthier, more supple skin, speed up wound healing and preserve bone strength.

CONTINUE READING to view the rest of this course…

Biologics | A General Overview

Biologics | A General Overview

What is Orthobiologics?

Orthobiologics refers to the use of biological substances to help musculoskeletal injuries heal quicker as well as treat the symptoms and functional impairments imposed by Osteoarthritis. They are used to improve the healing of fractured bones and injured muscles, tendons, and ligaments as well as stop pain and inflammation. It is inflammation that causes pain and leads to limited function in Osteoarthritis. Biologics are derived from substances that are naturally found in the body.

The substances include bone grafts, autologous blood, platelet-rich plasma (PRP), autologous conditioned serum, and stem cells.

In determining the appropriate treatment for your arthritic knee, for instance, the following criteria are taken into account:

INDICATION PROFILE

Function-Limiting Pain
• Function-Limiting Pain at Moderate to Long Distances

• Function-Limiting Pain at Short Distances

• Pain at Rest or Night

Range of Motion Extension/Flexion
• Full Range of Extension/ Flexion

• Lack of Full Extension (> 5-degree flexion contracture) and/or Flexion (< 110 degrees)

Ligamentous Instability (not to include antalgic giving way)
• No Ligamentous Instability

• Ligamentous Instability

Pattern of Arthritic Involvement
• Arthritic Involvement Predominantly in One Compartment

• Arthritic Involvement in More than One Compartment

Imaging (joint space most involved compartment)
• Mild to Moderate Joint Space Narrowing

• Severe Joint Space Narrowing

Limb Alignment
• No Varus/Valgus/Patellofemoral Deformity; bowleg /knock knee

• Varus/Valgus and/or Patellofemoral mal-alignment; knee cap

Mechanical Symptoms Compatible with Meniscal Tear or Loose Body?
• Mechanical Symptoms Present

• Mechanical Symptoms Absent

Age: physiologic and not chronologic
• Young

• Middle-Aged

• Elderly

Different criteria are taken into account for your other joints. How Biologics, when properly chosen and properly prepared and administered, may make a difference?

The following was received from a patient with fairly advanced osteoarthritis who underwent a Bone Marrow Concentrate knee intervention over five years ago:

October 15, 2021
Hi Doc
Here is the 2021 installment of A ____ & my taking annual trips. This year we traveled to Moab, UT and spent a week in the Arches & Canyonlands National Parks. While we didn’t log as many miles as last year, this year’s hikes were much more challenging. That is the trails in these parks are not clear & even. Rather they required a lot of scrambling (climbing up, over and around rocks and boulders). In the end all went off without a hitch and we had a wonderful time. Again, this would not have been possible without you and your staff. Next year, we will be attacking the Canadian Rockies.

You too can take a hike or bike, ski, and enjoy function without pain in your arthritic joint by calling (312) 475-1893. Visit my website at www.sheinkopmd.com. With two arthritic hips and two arthritic knees, having personally been managed with biologics these past five years, I was able to take a three-hour ride with my biking partner along the fabulous and beautiful Chicago Lakefront yesterday.

Your Orthobiologic Town Crier

Your Orthobiologic Town Crier

I receive a continuous flow of questions from patients pertaining to Regenerative Medicine; fundamentally, the majority have to do with FDA approval, safety, and efficacy? In general, my response may be summarized under two bullets:

1)  An understanding of the term “off label”
2) The difference between the biologic and the kit used for preparation

It is important to differentiate between a drug and the use of cells or tissues, the latter having been taken from your body. I will focus on Human Cells, Tissues, and Cellular-Based Tissue Products (HCT/P’s). Within the standard of the Practice of Medicine, as long as your cells and tissues are processed by FDA-approved techniques including preparation and the preparation kits, your cells and tissues may be used to relieve the pain and limited function caused by osteoarthritis. At times, grafts from donor sources may be used as long as they do not contain living cells.

The dilemma in the decision as to which biologic might be indicated is dependent on whether the problem is Osteoarthritis without inflammation; Osteoarthritis with inflammation; or a combination of Osteoarthritis with structural defects be those defects occurring in the articular cartilage, in the supporting bone (subchondral) or the menisci. In general, Platelet Rich Plasma (PRP) works through Growth Factors, proteins that are anti-inflammatory. Bone Marrow Aspirate Concentrate contains Mesenchymal Stem Cells that regulate via nano proteins called exosomes, additionally performing an anti-inflammatory function but with regenerative attributes as well.

Let’s switch to something more mundane, the first time you visit a physician for a painful joint, more likely than not, the recommendation will be a “cortisone” injection. In general, one or two steroid injections will do no harm; it is the preservative that harms cartilage cells. Triamcinolone is a corticosteroid that prevents the release of substances that cause inflammation and will benefit without harm. Should you receive a recommendation for a PRP injection into a joint, Leukocyte Poor is best for a joint while Leukocyte Rich is better for soft tissue.

Finally, what is the best treatment for the osteoarthritic joint? OA is multifactorial so the treatment of the process, not only the symptoms, is based on the understanding of causation:

1) Bone driven (subchondral lesions)
2) Metabolic (gout is the most common form)
3) Trauma (mechanical disruption of the bone supporting the cartilage or of the cartilage)
4) Cartilage (structural defects, meniscal tears)
5) Inflammatory (Rheumatoid Arthritis, Psoriatic Arthritis)

Now that I raised more questions than I answered, visit my website at www.sheinkopmd.com and schedule an office consultation by calling (312) 475-1893.

Paving the Way for the Next Generation of OrthoBiologics

Paving the Way for the Next Generation of OrthoBiologics

Last Friday was dedicated to an eight-hour virtual symposium: Orthobiologics in Non-Surgical Treatment of Knee Arthritis: Risks and Benefits for Your Patient; organized by the American Academy of Orthopedic Surgery. This is a milestone because the AAOS is the acknowledged leader in continued development, education, and leadership in musculoskeletal health. Until now, it has been open season without credentialing for anyone with a medical license including chiropractors, naturopaths, etc., to lay claim to the “stem cell” treatment for every malady that affects mankind. The charlatans and camp followers would charge excessive fees for “stem cells”. In an affirmative statement, The AAOS has literally partnered with the FDA for patient protection concerning the emerging discipline of Regenerative Medicine; and seized the initiative in helping to fund and accelerate research, safety, and efficacy.

One future strategy I will be pursuing, as a result of the symposium, is to modernize and advance the Platelet Rich Plasma treatment option. We think PRP and Bone Marrow Concentrate (BMC) work because of a sustained and longer expression of IL1-RA and TGF-B than other biologics (Growth Factors). Additionally, BMAC includes Mesenchymal Stem Cells (MSC’s) that contain exosomal proteins indirectly responsible for anti-inflammatory regulation in a joint. Is it possible to promote cellular reprogramming by changing the processing of PRP and thus decreasing the costs and eliminating the complexity of the Bone Marrow Concentrate experience? The way that MSC’s function is by signaling with extracellular Nano-particles. Mesenchymal stem cells do not morph, they signal. If we are able to extract similar signaling Nano-particles from your Platelets, then might the PRP act not only as an anti-inflammatory but in joint regeneration? Please remember, before I offer a treatment option in my practice, FDA approval is clarified and outcomes surveillance authorized by an Investigational Review Board.

On the one hand, the video clip attached to this blog should catch your attention as to the natural history of aging. On the other hand, the World Health Organization has done new research and defined a new criterion that divides human life as follows:

Age 18 to 65 years old: youth or young people
66 to 79: middle-aged
80 to 99: elderly or senior

After watching the attached video, you may decide how to change your future. Visiting my website at www.sheinkopmd.com or schedule an appointment (312) 475-1893 to learn how Biologics with a needle followed by a short rehabilitation and not a prosthesis with a knife and long rehabilitation might relieve arthritic symptoms and restore joint function.

 

 

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