Mar 25, 2021
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.
Mar 10, 2021
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.
Feb 26, 2021
Recent randomized controlled trials covering several hundred patients with approximately 15-year follow-up have documented that biologic repair of subchondral lesions for patients with osteoarthritis and osteonecrosis is a viable alternative to total knee arthroplasty. Readers of this Blog should be aware that I have been performing a combined Intraarticular and Intraosseous Subchondroplasty for over six years when indicated, for the appropriate patient, and this led to a research article published in September 2020. Quoting from my publication, “knee osteoarthritis increasingly is considered to be a whole-joint disease of which the degeneration of 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.” (Sheinkop et al, J Regen Med 2020, 9:3)
The above is evidence, but patients must be aware Biologics are increasingly being marketed. Many claims are being fraudulently advanced by charlatans, camp followers, and opportunists (prostitutes). One egregious example of fraud and abuse is the patient who presented to my office after failed therapy with Wharton’s jelly for which the patient has paid out an exorbitant sum of monies to chiropractors on three occasions. The following quote speaks for itself: “A regenerative medicine doctor recently asked the CBER division of the FDA if Wharton’s Jelly products were being correctly regulated and sold for use in humans. Guess what? The FDA said “NO”. All allograft stem cell Wharton’s Jelly products currently on the market in the USA are being sold in violation of FDA regulations.”
As an evidence-based practice, I use Orthobiologics-Proprietary Platelet Rich Plasma, Adult Mesenchymal Stem Cells from your bone marrow and most recently under FDA Clinical Trial approval, from your adipose tissue, as well as Growth Factors and proteins in your circulating blood to improve outcomes for orthopedic patients. While requirements for evidence of safety and effectiveness vary greatly, in addition to FDA-approved clinical trials, leaders from the American Academy of Orthopedics Committee on Devices, Biologics & Technology are assuring compliance with the regulatory landscape. The AAOS Biologics Initiative and the Academy are investing heavily in this evolving area of medicine to protect the patient.
Schedule Your Office Visit | Evidence-Based Orthobiologics
To learn if orthobiologics and cellular orthopedics might minimize your symptoms related to arthritis and maximize your functional capacity enabling golf, cycling, running, etc. visit my website at www.sheinkopmd.com. To schedule an office consultation or even for a second opinion to learn if you might delay, perhaps avoid surgery for arthritis with a needle, not a knife, call (312) 475-1893.
Feb 23, 2021
The Thrill of Yesteryear Powered by Orthobiologics
On Saturday, my wife, oldest son, granddaughter, and I returned from a six-day ski trip to Vail Colorado. I skied five out of five days. While avoiding moguls and the advanced expert runs, I humbly admit that on fresh powder, I became ageless. There is nothing more invigorating than returning to “the thrilling days of yesteryear”, letting yourself enjoy the Rocky Mountain High with family, and throwing caution to the wind on fresh powder.
My preparation has been ongoing as training and physical fitness are part of my daily lifestyle. Nevertheless, the cumulative and repetitive injuries over the years have taken a toll and I have fairly advanced osteoarthritis of both knees. About three weeks before we departed to Vail, I underwent a Growth Factor/Stem Cell intervention into both of my knees. There is little, if any, possibility of cartilage regeneration at my age but that injected, derived by filtering and processing my own blood, is a very successful way to control the inflammation in the osteoarthritic joint. While still a relatively recent introduction into the realm of Orthobiologics, the Growth Factor/Stem Cell approach, hopefully will enable me to keep up a high level of performance for several years before repeating the process.
As I look ahead, the weather forecast is for increasing temperatures so that my fancy turns to fly fishing and cycling. While there still may be a late-season repeat ski trip this year, my focus will turn to wading up a trout stream in the driftless area of Wisconsin with a fly rod in hand and those outdoor cycling adventures. While all this is ongoing, I am in continued communication with Personalized Stem Cells Inc., those responsible for the recently completed first FDA overseen clinical trial using adipose-derived stem cells for the arthritic knee joint.
Schedule Your Office Visit | Evidence-Based Orthobiologics
Readers of this blog are aware that I was a co-investigator and major contributor to the Clinical Trial. You may learn more by visiting www.PersonalizedStemcells.com and be updated about the next FDA approval of clinical trials for arthritis. You may schedule an office visit and learn about how my evidence-based orthobiologic and bone marrow-derived stem cells practice may help you “return with me now to the thrilling days of yesteryear” by calling (312) 475-1893.
Feb 11, 2021
On Tuesday, a patient presented with a problematic left knee. She had been walking her dogs when she was attacked by a pit bull. In escaping, her left knee twisted violently, and over the past several weeks, the pain, limp, and swelling have remained. In reviewing her medical records, I was reminded that in 2012, she became the 40th patient I had treated with a Bone Marrow Concentrate for an osteoarthritic knee.
Fast forward to 02/09/2021, until the recent traumatic event, the patient has been symptom-free without limitation of function or lifestyle. When I reviewed the X-ray taken last week and compared the images on file from 2012, there was no appreciable difference in more than nine years. In other words, the Platelets, Adult Mesenchymal Stem Cells, Precursor Cells, and Growth Factors in the Bone Marrow Concentrate successfully eliminated the symptoms and functional limitations secondary to osteoarthritis.
Limited Long-Term Outcomes Using Bone Marrow Concentrate, Until Now
Why this case is of special importance (actually, all patients are) has to do with the relative paucity of long-term outcomes using Bone Marrow Concentrate for osteoarthritis. In 2012, the belief and teaching revolved around the stem cell. More recently, we have recognized that the Growth Factors play an equally important role in the treatment of the arthritic joint, perhaps even more so than stem cells.
My scientific clinical research publications in the discipline of Regenerative Medicine have been based on one to four-year outcomes. This Blog’s subject may represent the longest clinical follow-up of a patient with an arthritic knee that has been treated with Bone Marrow Concentrate. While most patients want to know how quickly following a biologic intervention, they will experience symptom relief and functional improvement, equally or perhaps even more important is the long-term success of the cellular biologic procedure.
Since 2012, I have gathered evidence as to which biologic procedure is best suited for the needs of an arthritic joint. My care is evidence-based. The range of treatment options includes proprietary Platelet Rich Plasma, Bone Marrow Concentrate, Growth Factors, and Adipose-Derived Stem Cells, the latter made possible by my clinical research relationship with Personalized Stem Cells, Inc. While the first PSC FDA approved Clinical Trial for osteoarthritis of the knee has been completed, we hope to receive FDA approval for the next clinical trial.
To learn more about my Biologic Practice using a needle, not a knife for the treatment of arthritis, visit www.SheinkopMD.com. Schedule an appointment by calling (312) 475-1893. You may follow the announcement of the next Personalized Stem Cell FDA approved clinical trial for an arthritic joint at www.PersonalizedStemcells.com.
Oct 19, 2020
There are two clinical, readily available sources of adult mesenchymal stem cells, to the cellular orthopedist; the musculoskeletal building cells that have the potential to stop the progression of arthritis. These cells may reverse the damage, regenerate cartilage, and eliminate the pain generator, inflammation. MSCs work in conjunction with platelets and proteins called Growth Factors.
In my clinical evidence-based setting, we have explored and continue to investigate the several possible approaches to treating the arthritic joint with either your adult mesenchymal stem cells, your platelets and /or your growth factors either separately or in combination with each other. I have previously authored or co-authored the results of the clinical outcomes of using adipose derived approaches to arthritis and bone marrow concentrate containing stem cells in restoring the arthritic joint to well-being. My most recent scientific publication is based on using concentrated bone marrow both in the joint and in the subchondral bone adjacent to the joint as there is increasing evidence regarding the role of the subchondral bone in the causation of arthritis.
Mesenchymal Stem Cell Treatment Clinical Trial Update
This past Thursday night, the several of us involved in the first FDA approved, recently completed, Clinical Stem Cell Trial (Personalizedstemcells.com.), reviewed the preliminary responses in 38 enrolled patients. First and foremost, we recorded no serious adverse events; no complications from the drug injected after liposuction and preparation. Several minor complaints were observed as part of the liposuction process. Of the 38 patients, the vast majority are enjoying a positive response in the treated arthritic joint. The FDA has required our monitoring the patients for a year; however, our next milestone follow-up will be at day 84 from the time of the joint injection.
Based on what we have learned to date about the safety and efficacy of adipose derived stem cells in the treatment of the arthritic knee, our investigators under the auspices of PersonalizedStemCells.com will be applying for a second phase clinical trial at the knee; but additionally, safety and efficacy for the hip and for several joints at the same time. I will announce the start of trial enrollment when approved in this blog and on my website, www.sheinkopmd.com.
These new clinical trials probably will not be open to enrollment until December or perhaps the first quarter of 2021. For those patients who are seeking relief now without jeopardizing participation in the clinical trial, call (312) 475-1893. I offer a full menu of biologic interventions for the arthritic joint including concentrated bone marrow, Proprietary Platelet Rich Plasma (PRP), Growth Factors and other Orthobiologics and determine which is the best option at the time of the office visit
Tags: cellular therapy, clinical study, clinical trial updates, stem cell clinical trials, stem cell treatments
