Are We There Yet?

Dec 1, 2021

With better drugs and stem-cell therapies, using these biologics, we hope to repair cartilage — or prevent damage — before 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.

Biologics | A General Overview

Nov 11, 2021

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

Oct 19, 2021

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.