Last Friday night, I was involved in a conference call with Personalized Stem Cells Inc., to review the outcomes of the first FDA-approved, Adipose Based, Stem Cell Trial and to assist in planning the second trial for knee arthritis. We hope to initiate the second trial, with FDA approval, by mid-June. Between now and then, the inclusion criteria for those who would become patients in this second trial will be established, in part, based on the analysis of the first trial. I am happy to report that there were no serious adverse events in the patients participating in the first trial, with the Adipose-Derived Stem Cells and Stromal Vascular Fractions having proved safe; and for the majority, effective. Such inclusion criteria as patient age and degree of arthritis in the symptomatic joint and the less involved knee will be established for the next FDA submission.
Arthritic Knee | Clinical Vignette
Now, for a change in subject matter and back to clinical orthopedics, a 64-year-old patient presented this morning with a specific request to treat his arthritic knee so he could get back to running since he has recently retired. An assessment was completed, and it was determined that the problem is grade two to three osteoarthritis of the left knee. A diagnostic ultrasound was compatible with an accumulation of intraarticular fluid termed an effusion. The latter is a result of inflammation, as the symptom generator and altered physical finding in an arthritic joint are the result of inflammation. I indicated to the patient that before making a therapeutic recommendation, an X-Ray and an MRI of the left knee would be necessary. The short-term recommendation is a Hyaluronic acid injection although the latter has neither anti-inflammatory nor regenerative potential. Both Cortisone injections and hyaluronic acid injections are short-term treatments if effective.
Based on the results of the X-ray and MRI, the patient may be a candidate for a Bone Marrow Concentrate intervention as a means of stopping the progression of arthritis, minimizing, or perhaps eliminating symptoms, and restoring functional capacity. The other alternative, should the patient not be deemed a suitable candidate for the use of his bone marrow, would be the use of Growth Factors, proteins found in his circulating blood. These anti-inflammatory Cytokines, manufactured by your platelets, immune system, and liver are proving as important as stem cells in minimizing the symptoms and functional impairment imposed by an arthritic joint.
Cell-Based Therapies | Using a Needle and NOT a Knife
The discipline of regenerative medicine is dynamic and rapidly evolving. This makes it that much more important for a patient seeking a needle rather than a knife, to minimize or eliminate the symptoms and limitations imposed by osteoarthritis to depend on experienced experts for care and treatment. Let there be no hesitation in seeking a second opinion before deciding on the best clinical path for you.
To learn more, visit my website at www.sheinkopmd.com where you will find a webinar on cellular orthopedics. For a consultation, call (312) 475-1893. To follow the progress in the introduction of the next phase Clinical Trial, watch this website or check www.personalizedstemcells.com.
I have previously shared with readers of this Blog, the fact that about eight weeks ago, in anticipation of a Colorado ski trip, I personally underwent an orthobiologics injection into both of my arthritic knees. Those biologic injections with proteins termed Growth Factors, recovered from my own blood, allowed me to ski five consecutive days in Vail, Colorado, basically having returned me to the thrilling days of yesteryear. This past weekend, I made my first seasonal pilgrimage to the trout streams of Southwest Wisconsin in the Driftless Area. While the outdoor temperatures were in the mid-50s, there still were deep snowdrifts along the stream edges so we had to trudge through the snow, and uneven terrain and then up the rocky stream bottoms. That was on Saturday and Sunday. Today, I saw patients without a limp and without any knee discomfort.
Orthobiologics include Hyaluronic Acid, Platelet Rich Plasma, Growth Factors, and Adult Mesenchymal Stem Cells derived from your bone marrow; all FDA approved as part of the standard of practice. In addition, under the auspices of an FDA-approved clinical trial, we have used adipose-derived stem cells for knee arthritis and are planning an application for a second trial as an investigator for the Personalized Stem Cell initiative. You may follow the progress of that application at www.personalizedstemcells.com.
Upcoming Second Personalized Stem Cells Clinical Trial
As far as indemnification or out-of-pocket costs, for those who meet the inclusion criteria of a Clinical Trial, there are few out-of-pocket expenses other than the facility fee. When it comes to the menu of biologics, an ever-increasing number of options are covered by health insurance and Medicare. Should you be interested in learning if you meet the inclusion criteria for the upcoming Personalized Stem Cells Clinical Trial, the first step is to call (312) 475-1893 and schedule an initial screening. At that visit, an evaluation will be made of the arthritic knee and X-rays will be requested. Based on your medical history, orthopedic physical examination including the Range of Knee Motion, Mechanical Joint Alignment, Body Mass Index, and grade of arthritis as graded on the Knee X-ray, we will determine If you meet the inclusion criteria established by the FDA for the second Personalized Stem Cells Clinical Trial. As we anticipate the FDA approval for the next clinical trial by the end of the second quarter of this year and since the number of patients to be included in this next trial is not yet established, interested patients might consider scheduling that screening visit sooner and not waiting for an official announcement.
Benefits of a Cell-Based Therapies | Using a Needle and NOT a Knife
For those who do not qualify for the PSC Clinical Trial or have a symptomatic joint with altered functional capacity other than a knee, you may learn more at www.sheinkopmd.com to explore cell-based therapeutic solutions at my practice and the varying and potential benefits of a needle and not a knife.
Better stated, how do you bridge the gaps in the continuum of joint care from early intervention to joint replacement?
Arthritic Joint Pain Management
First and foremost, our goal is functional restoration and maintenance, relieving symptoms, and postponing, perhaps avoiding joint replacement. In the beginning, conservative measures might include non-steroidal anti-inflammatory medications, weight reduction, physical therapy for strengthening muscles and preserving or restoring a full range of joint motion. At times, an unloader brace may be of benefit in settings where a joint shows early signs of mechanical changes such as a knock knee (valgus) or bowed leg (varus). In addition to the aforementioned measures, joint preservation is a major goal using such measures as Platelet Rich Plasma, Highly Cross-linked Hyaluronic Acid and Acellular Amniotic Fluid.
Within the Preservation Classification, there are multiple options available. Our evidence-based practice concentrates on those options in which we have done outcome research; as well as published our results in scientific journals. Only using evidence-based options allows us to provide the patient the highest chance of a successful outcome.
Cellular Therapy to Treat Joints
There are times in the continuum of care that the patient will present further along in the arthritic process so that Conserve and Preserve are no longer indicated. Joint Restoration is the next consideration that might or could go a long way in postponing or even avoiding a joint replacement. Autologous Growth Factor Solutions contain proteins circulating in your blood that potentially stops pain, and reverses the arthritic process at the molecular level in the joint. The ultimate Regenerative Orthopedic approach is stem cell mediated and bone marrow concentrate is the only FDA approved source of mesenchymal stem cells at this time. Your bone marrow is recovered by an outpatient aspiration procedure, the recovered bone marrow via a specially designed needle, (troachar), contains adult mesenchymal stem cells, exosomes, platelets, growth factors and precursor cells. When concentrated, your bone marrow is the richest source of joint restoration potential available to date. It is FDA approved as long as guidelines are adhered to; has no potential for disease transfer; and offers pain relief, return of motion and function, and postponement, perhaps avoidance of a joint replacement. Please note that I indicated “at this time.”
The Personalized Stem Cell trial in which I played a major role just concluded. The results are being analyzed. In the PSC Trial, the source of stem cells was adipose tissue, abdominal fat. When approved, Personalized Stem Cells will allow abdominal fat to serve as an alternative source of stem cells in addition to bone marrow on a clinical basis. The next advance will come following the FDA approval for the PSC trial of stem cell culturing. To stay informed, read my weekly blog. To schedule a consultation call (847)390-7666. You may visit my web site and attend a webinar at www.sheinkopmd.com
Tags: arthritic joint pain, arthritis, cellular therapy for arthritic joints, joint, joint pain, preventing joint replacements
This excerpt is taken from the full article, which can be read here. Copyright © Mitchell B Sheinkop and Maxwell Dordevic,2019,
This case report will introduce the concept of using an acellular mesenchymal stem cell (MSC) derived extracellular vesicle isolate product (EVIP) containing active growth factors (GFs) and exosomes to treat hip osteoarthritis (OA) as well as the rationale of why acellular may replace all current cellular biologic therapies both autogenous and allogeneic presently in use.
INTRODUCTION Hip osteoarthritis (OA) has demonstrated, in both cadaver and radiographic studies, to affect up to 55 million patients over the age of 60.1 Patients with hip OA have pain, crepitus, loss of motion, and decreased ability to weight bear or ambulate. Limiting the ability to ambulate severely impairs activities of daily living. The nonsurgical treatments for hip OA according to the American Academy of Orthopedic Surgeons (AAOS),include weight loss, gentle exercise, and the use of non-steroidal anti-inflammatory medications. The surgical treatment for hip OA is total hip arthroplasty (THA).2 The AAOS does not recommend hip arthroscopy or the use of any Hyaluronic Acid injections. Over the last few years, it has become increasingly understood by researchers and clinicians that the clinical efficacy of utilizing mesenchymal stem cells (MSCs) to treat osteoarthritis (OA) is not dependent on the cells differentiating into articular cartilage but entirely on their paracrine release of growth factors (GFs) and exosomes. Living MSCs are not required to accomplish the release of GFs and exosomes into an arthritic joint. This case report will introduce the concept of using an acellular MSC derived extracellular vesicle isolate product(EVIP) containing active growth factors and exosomes to treat hipOAas well as the rationale of why acellular may replace all current cellular biologic therapies both autogenous and allogeneic presently in use.
MATERIALS AND METHODS This is a case report of an EVIP injection for the treatment of hip osteoarthritis. OA is defined by swelling, pain, and stiffness in the hipjoint. Symptoms are typically worsened by weight bearing and ambulation.Radiographs and MRI scanning wereused tograde osteoarthritis of the hip joint from one to four using the Kellgen-Lawrence scale.12 The patient is a 63-year-old retired Chicago Fireman. He presented with increasing pain in the left groin and a progressive loss of ability to continue his daily health club fitness routine. He experienced a progressive loss of hip mobility.MRI scanning and radiographs of the left hip joint were compatible with Kellgren-Lawrence Grade 3 osteoarthritic changes of the left hip joint. On physical examination, he had an antalgic limp and a positive Trendelenburg sign. Passive ROM of the hip joint was associated with the reproduction of severe groin pain, crepitus, and a loss of internal rotation. The patient had a BMI of 27. NSAIDs had failed to provide adequate pain relief. The patient was seriously considering total hip arthroplasty. In an attempt to avoid surgery, he elected to have an injection of an EVIP containing active GFs and exosomes into his hip.
Read the full article at here.
Mitchell B Sheinkop and Maxwell Dordevic.2019, Intra-Articular Injection of An Extracellular Vesicle Isolate Product to Treat Hip Osteoarthritis. Int J Recent Sci Res. 10(12), pp. 36230-36232. DOI: http://dx.doi.org/10.24327/ijrsr.2019.1012.4884
Tags: clinical trial, Osteoarthritis, patient results, published article
Those who regularly read my blogs are aware that for the past several years, I have stated that there are no living stem cells in Birth Tissues such as Wharton’s Jelly. Umbilical Cord Blood, Placental Tissue and Amniotic Fluid. Nevertheless, as recently as last winter, the Stem Cell Institutes of America continued to hold seminars and make claims regarding cartilage regeneration after an injection of Amniotic Fluid. Ultimately, it was investigative Reporter Pam Zekman, at WBBM-TV in Chicago who exposed the fraud. At the about the same time, The Interventional Orthopedics Foundation published a position statement after investigating the many birth tissue products in the marketplace and found virtually no living stem cells in the many alternatives after processing, freezing, storing and thawing at the time of use. On currently, an article was published in the American Journal of Sports Medicine, again indicating that Birth Tissues were acellular-lacked living stem cells when processed and thawed.
My practice is based on Orthobiologics so misleading statements, bad actors, charlatans and liars for that matter are not my favorite people to say the least. Let’s update where the Birth Tissue purveyors have taken their most recent marketing campaigns now that the FDA and FTC are closing in. My favorite misleading statement is the Stem Cell Recruitment headline boldly appearing on the multiple outdoor advertising billboards ringing Chicago Tollways. There is no such thing as stem cell recruitment. A product introduced by a large pharmaceutical company several years ago had to be withdrawn when no such recruitment was scientifically demonstrated in an arthritic joint.
Now the marketing of Birth Tissues, that is Wharton’s Jelly, Umbilical Cord Blood, Placental Tissue and Amniotic Fluid has evolved from stem cells to Growth Factors. After all these years of claims to the contrary, the Birth Tissue Pharmaceutical manufacturers have admitted their products are acellular. The FDA and FTC have not yet taken a position on Growth Factors; these naturally occurring substances capable of stimulating cellular growth, proliferation, healing and cellular differentiation. In the past ten days, no less than four different orthobiologic distributors have admitted to me that Birth Products are acellular, that is lacking in stem cells, but it really isn’t significant because they have Growth Factors. I practice evidence-based medicine and to date, there is not one statistically significant, scientific trial documenting more than three months of pain relief with Birth Tissues, most recently marketed as a source of Growth Factors.
Will the attempt at making Birth Tissues great again by a change in marketing strategies result in relief of your joint pain and improve your function? Perhaps but it will take several years to document the results. In the meantime, we have published scientific evidence to support our approaches to relieving pain and improving function of the arthritic joint. To schedule a consultation, call (312) 475-1893.
You may visit my web site at sheinkopmd.com.
Now you know it, I have degenerative arthritis of both knees. It has affected me for more than ten years. In 2017 because of progressive symptoms and limitation, I had thought that I would need to give up skiing, cycling and fly fishing. At the time, imaging was compatible with grade 4 OA at the patellofemoral part of the joint; but grade 2 to 3, between tibia and femur. My decision in late December of 2017 was a proprietary Platelet Rich Plasma filtered concentrate into both knees and it worked (growth factors). I skied, cycled and walked up spring creeks in Southwest Wisconsin all of 2018 and most of 2019 but now limited discomfort is recurring and my gait is changing. While as most persons over 65, there is some degree of wear and tear in the low back contributing to my discomfort after prolonged standing; the pain generator is inflammation from osteoarthritis of my knees. The question for me now is whether to repeat the procedure of 2017 that was successful in relieving pain and improving function by concentrating platelets and filtering the growth factor proteins in my plasma?
Fast forward to the end of this year or the beginning of 2020. The Personalized Stem Cell FDA application for The Clinical Trial using Adipose Derived Stem Cells to treat knee OA, Grade 2 to 4 has been approved as of late July of this year. As you may have learned, ours is the first center in the Country to have been trained and credentialed to recruit and perform the procedure (www.sheinkopmd.com and www.personalizedstemcells.com); several patients are now scheduled for the procedure and four more scheduled for the prescreening process. My personal issue is that I have OA affecting both knees. PSC has indicated it will be applying for FDA approval to treat patients with bilateral knee osteoarthritis sometime after mid-November. In order to assure my preparedness to ski in January and February of 2020 with full recovery and rehabilitation, I will need to have instituted treatment by December 1. As well, while the Wisconsin trout fishing season ends on October 15, it reopens about January 6. For those not familiar, the hiking, climbing, crawling and unstable walking in or along a spring creek can be as demanding as skiing down a mogul run on the ski slopes out West.
Here is my plan based on my stem cell experience, biologic familiarity, and privilege of having been selected as a Center of Excellence for the Personalized Stem Cell FDA approved Clinical Trial. If the FDA approves the PSC bilateral application by mid-November, I will opt for the latter. On the other hand, if my self-imposed recreational time table is in doubt of being kept, I will repeat the IRAP (PRP growth factor) interventions and then opt to proceed with the PSC undertaking when possible. To learn more about the Personalized Stem Cell Trial, call (847) 370-4523, To schedule an office visit, call (312) 475-1893
Good running, cycling, skiing, walking, golfing, boating, fly fishing, curling, bowling etc., etc., etc.