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.
Autologous Regenerative Therapies

Autologous Regenerative Therapies

You may have seen this subject matter before but research and everyday experience reminds me that one has  to hear the informed consent three times for the best retention.

Clinical translation of regenerative medicine technologies requires a source of stem and progenitor cells and growth factors. The most success in Cellular Orthopedics to date has come from Bone Marrow Aspirate Concentrate wherein concentrations of mesenchymal and hematopoietic stem cells and soluble growth factors are recovered, concentrated and the joint intervention shortly follows. The procedures we use offer an FDA-compliant means of concentrating autologous stem and progenitor cells, platelets and growth factors to be used in the treatment of osteoarthritis of a joint. In a single event, we may introduce a means of pain relief, increase joint motion, improve activity and quality of life, reverse osteoarthritic changes on a bio-immune basis and possibly affect joint regeneration.

The standard of Regenerative Medicine remains Bone Marrow Aspirate Concentrate; the most studied approach in clinical practice. I am aware of the option of Fat Graft Harvesting, Micro-fracture of the Fat Graft and injection of the emulsified adipose tissue into a joint; but to the best of my knowledge at this time, the clinical outcomes results are no longer than 90 days, so stay tuned or just keep reading my Blog to update.

Platelet Rich Plasma preparation process certainly has improved over the past several years and now allows for protein and growth factor concentrating but with the notable absence of the Progenitor Cells ( Mesenchymal Stem Cells, Hematopoietic Stem Cells, etc.)

Amniotic Fluid Concentrate has recently gained traction in the clinical practice setting as a replacement for Hyaluronic Acid derivatives or synthetic  alternatives but the clinical results are only now being studied. I have said it before and I will emphasize, there are no living Stem cells in Amniotic Fluid Concentrate after sterilization and processing. That is not to say, AFC is not a superior option with a longer lasting pain relieving anti-inflammatory benefit to Hyaluronic acid based offerings.

There is no test now that you have studied my Blog but hopefully you are more familiar with Regenerative Therapies. As part of my Clinical Practice, we have developed the Center for Clinical Investigation. To learn what might best suit your needs, call 847 390 7666 and schedule a consultation.

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Cartilage repair revisited

Articulate cartilage has little to no capacity to undergo spontaneous repair because it has no blood supply nor is it able to regenerate across a physical gap. In order to restore cartilage in a skeletally mature patient, there is a need for outside help. In some settings, osteochondral transfer (bone with cartilage) may be harvested from elsewhere in a damaged joint and repositioned or relocated in that joint. In other settings, fresh cadaveric tissue (allograft) may be used. More recently, attempts have been directed at “engineering” cartilage. For engineering to take place, there are three requirements. First must come a matrix scaffold necessary to support tissue formation. Second are cells such as mesenchymal stem cells either from bone marrow or synovial membrane lining the joint. Third comes signaling molecules (cytokines) and growth factors. Platelet Rich Plasma is a source of signaling molecules. While Bone Marrow Concentrate doesn’t meet every need for tissue engineering, to the best of my knowledge at this time, there is nothing superior for a long term successful outcome either as an adjunct to a surgical procedure for a small defect or as a primary intervention for an arthritic joint.
There are several ways to measure success after an attempt at cartilage repair. For a contained or global defect, MRI is the primary outcome measure; whereas for osteoarthritis, the Outcome objective metrics I use have proven statistically significant and reproducible. I write this Blog in between presentations by the faculty at American Academy of Orthopedic Surgery Program: Articular Cartilage Restoration-The Modern Frontier. I came here to learn and learn I did about surgical procedures for contained injury. When it comes to osteoarthritis, I learned little but contributed much. No, I am not being egotistical, I am reporting what transpired at the meeting and what is transpiring in my practice. Of interest is the universal agreement by those treating the global defect with surgery and those of us who treat osteoarthritis with stem cells; including the supporting bone ( bone marrow edema)in the therapeutic algorithm via subchodndroplasty is paramount.
“He, who has data, need not shout”

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Why the need for restoration of articular cartilage

Cartilage damage may result from trauma, repetitive motion/impact, abrupt abnormal weight bearing, fractures, wear/degeneration, joint infection, meniscectomy,  friction/abrasion due to abnormal joint alignment, inflammatory diseases or a genetic predisposition to name a few reasons. The primary symptoms are pain, loss of motion and functional impairment.

As a form of connective tissue that is very primitive from an evolutionary standpoint, cartilage does not lend itself to intrinsic repair. All the attributes required for healing, while present in bone, are missing in cartilage including blood vessel supply, pain fibers, regenerative cells, fluid balance, and a rich source of nutrition.  The cartilage in your joint is not populated by metabolically active cells nor is the chondrocyte capable of positively influencing  its own environment. In keeping with all of the principal shortcomings of cartilage, chondrocytes do not replicate after age 40 and cannot migrate.

Because articular cartilage damage from any of the aforementioned causes is permanent and progressive, it is paramount that intervention takes place early in the degenerative process or soon after injury. The likelihood of a successful, enduring repair or restoration diminishes as generalized cartilage deterioration progresses.

There are many palliative interventions available such as weight loss, non-steroidal anti-inflammatory medication, shoe wedges, off-loader braces, cortisone injections, gels/visco-supplementation, and most recently, amniotic fluid concentrates. Missing though from all of these options is the regenerative potential. Bone Marrow Aspirate Concentrate not only introduces regenerative potential via adult mesenchymal stem cells, it is a huge resource for anti-inflammatory molecules termed cytokines. Equally important though are the extracellular vesicles (exosomes) termed growth factors.  What about adipose derived stem cells and cultured stem cells?

While adipose tissue contains stem cells, the latter are not available unless liberated from their surroundings. An enzyme, collagenase has been the necessary ingredient but the use of collagenase is interpreted as tissue manipulation and thus not allowed by the FDA. While there was an introduction last July of a mechanical means of liberating stem cells from fat graft harvest, there are no outcomes as of yet to support said alternative. At the same time, while adipose derived stem cells have been used outside of the US, there are no studies indicating better outcomes with adipose derived cells as compared to bone marrow derived stem cells. The remaining question at this time is whether the results of cultured stem cells are superior to Regenexx SD outcomes. While there is anecdote, we have no Evidence Based Information to help guide Clinical Appropriate Use Criteria.

With all the above written, I am  done for today; if you are still unclear or uncertain, call the office for an appointment.

847 390 7666

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What’s ahead in Cellular Orthopedics for 2016

The Regenerative Medicine Menu

  • Hydrocortisone
  • Hyaluronic Acid (HA)
  • Platelet Rich Plasma (PRP)
  • Amniotic Fluid Concentrate (AFC)
  • Bone Marrow Aspirate Concentrate (BMAC)
  • Regenexx-SD Procedure
  • Simple Adipose Graft
  • Stromal Vascular Fraction (SVF)

 

The human body posses a remarkable capacity to heal. Following tissue damage or disease, the body’s immune response coordinates a sequence of events to fight off harmful disease or infections and repair the damaged tissue. While scar tissue may form as a byproduct of rapid healing, scar tissue may be remodeled over time. This is the Normal Healing Response. The goal of regenerative therapies is to modulate these stages of healing be it soft tissue, cartilage or bone.

As a response to the delisting by the AAOS of Hyaluronic Acid from the osteoarthritis armamentarium, industry has attempted to fill the void with Amniotic Fluid Concentrate. For those unfamiliar, when a pregnant woman schedules a C-Section, she is approached about “donating” her amniotic fluid that may be recovered at the time of the procedure. During the course of the pregnancy, the potential donor is screened for communicable diseases. There is little if any immuno-rejection phenomenon and the AFC has growth factors, anti-inflammatory cytokines and Hyaluronic acid all in high concentration. While there are large numbers of stem cells deposited by the fetus and the placenta during the course of the pregnancy, by time the Amniotic Fluid is concentrated, processed, frozen for preservation and finally fast thawed for usage, little in the way of viable stem cells may be observed. Never the less, the AFC has great potential in the arthritic setting; and when micronized, is a marvelous adjunct in effecting wound healing for the diabetic and wound that won’t heal.

At our Regenerative Pain Center, we have observed over 40 different interpretations for the term PRP. The problem is that there is no standard of concentration, quality or quantity. To that end, an attempt is underway to reach accord on an actual standard definition. Then there comes the dilemma of whether the PRP is best when leukocyte free or not. Next comes the argument to support Platelet Poor Plasma (PPP). In our practice, we alter the formula according to the needs of the patient.

You will note at the get go, the repeat Bone Marrow Aspirate Concentrate bullets. There is bone marrow aspirate concentrate and then there is the Regenexx -SD approach. The latter is what has been so effective in our practice for three and a half years; so much so that it is what I truly believe in for moderate osteoarthritis and even advanced in certain settings.

While “simple” adipose grafts are heavily marketed, let me refer you to Pope Brock’s Charlatans, first published in 2008 to understand my view of how plastic surgeons are victimizing patients by including the management of arthritis in their cosmetic approaches. Last of all is the new introduction of the Stromal Vascular Fraction following the micro-fracture of fat graft. The latter became available in the US in mid summer, 2015. Clinical trials are in progress. If you want to delay or possibly avoid a joint replacement for arthritis, call for a consultation     847 390 7666

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Autologous Regenerative Therapies

News from the Interventional Orthopedics Foundation

In spite of what a patient may be told by the physician and what salesmen tell the doctors, research by the Interventional Orthopedics Foundation laboratories found no viable stem cells in Amniotic Fluid Concentrate once shock thawed. While there may have been living stem cells in amniotic fluid when harvested, part of the commercial preparation and storage requires freezing. Once shipped for clinical use, the preparation is quickly thawed (shock thawing) as required for injection. While a slow thaw over 24 to 48 hours will preserve stem cells, shock thawing kills cells although the hyaluronic acid content and the Cytokine/Growth Factor content is maintained. The net conclusion is that Amniotic Fluid Concentrate may be beneficial as a symptom altering intervention but with no regenerative potential.

Analysis of the available enzymatic means of liberating stem cells from fat is a violation of FDA restrictions. The Interventional Orthopedics Foundation has been aware of the increasing claims that adipose derived stem cells are superior to Bone Marrow Aspirate Concentrate derived stem cells in various orthopedic conditions. As such, the Foundation studied the law and the proprietary claims. The conclusions reached are that there is no scientific data or publications to support the claims of superior outcomes of fat over bone marrow and the use of the enzyme, collagenase to liberate the stem cell from the adipose tissue is violation of FDA guidelines. By the same token, the introduction of a mechanical means to liberate biologically active molecules from fat may fall within FDA guidelines but the impact in arthritis has yet to be clinically documented.

No consensus has yet been reached regarding the substitution of Amniotic Fluid Concentrate for hyaluronic acid in relieving the symptoms of degenerative arthritis. The necessary clinical evidence to support a change in skeletal muscular practice guidelines is still being collected. As of January 1, 2016, I will be participating in that latter initiative in my interventional orthopedic practice. The Interventional Orthopedics Foundation also recognizes the absence of a scientific based means of helping a patient delay or even avoid a joint replacement for advanced arthritis. What we are able to do now and for which we have supporting data is to successfully intervene in Grades two and three osteoarthritis. Beginning in December, I will be initiating a clinical trial that is designed to meet the challenge in advanced arthritis but we will not have statistical evidence of a successful outcome for some time.

If you want more information regarding proven methods using Interventional Orthopedics for delaying or even avoiding a joint replacement in Grades 2 and 3 arthritis or what may be possible for advanced osteoarthritis to avoid a joint replacement, schedule your consultation at 847 390 7666. For those patients who have been told they have too serious a co-morbidity to allow for a joint replacement, let us try to help you as well using needle instead of a scalpel.

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