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.
Limited treatment options for Osteoarthritis exist, and the current therapies are all palliative. They only address the symptoms but fail to address the root cause: cartilage damage from the activity of degradative enzymes (proteases) that destroy the arthritic joint. That’s why we usenovel treatments to operate at the molecular level. Successful treatment must combat the degradative enzymes at a molecular level.
Standard Non-operative Treatment Options
Non-steroidal Anti-inflammatory Drugs
Analgesics
Hyaluronic Acid Injections
Corticosteroid injections
Physical Therapy, Weight Reduction, Bracing
Unpredictable Outcomes
Temporary symptomatic relief
Treats the symptoms, not the cause
Many side effects
Hip Intervention for Osteoarthritis | Evidence-Based Care
“Have to say from year four to five no deterioration. In fact, maybe feeling a bit better.
– Still maintaining a daily self-initiated PT regime for leg strength. That soreness (uncomfortable) mostly right below the knee cap and back of pelvis seems to have dissipated. – Finally developing a normal gait.”
When treating an arthritic joint with biologics, the partial improvement may be immediate, or maximum medical improvement may take months, perhaps years. If you want to avoid a knife for an orthopedic impairment, call(312) 475-1893 to schedule your consultation. You may continue reading more at my website: www.sheinkopmd.com.
Personalized Stem Cells, Inc (PSC), a clinical-stage biopharma cell therapy company, announces the results of its single knee osteoarthritis phase 1/2a clinical trial. The final study report has been submitted to the FDA for review and in support of a full-scale randomized controlled trial to be conducted later this year.
Safety was the primary objective of this study and there were no serious adverse events reported. The efficacy of the experimental cell therapy in knee osteoarthritis was measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and showed that 79.3% of the patients improved above the “minimal important change” (MIC) with an average improvement over baseline of 2.2 times the MIC. The KOOS measures pain, other symptoms, daily function, sports, and knee-related quality of life outcome sub-scales.
PSC Founder and CEO, Dr. Bob Harman, stated, “We are pleased at the strong safety profile and efficacy results in this FDA-approved clinical study of stem cell therapy for knee osteoarthritis. The 15 years of veterinary experience with adipose-derived stem cell therapy of our parent company, VetStem Biopharma, provided the basis for our FDA study submission and approval and provided valuable insights into the study design and conduct.” There were 39 participants in the study enrolled across seven sites in the US. I am one of the several trial centers having participated in the Trial.
The cellular drug used is autologous (patient-derived) mesenchymal stem cells from fat tissue. This study was unique in that the patients were treated with their own stem cells, which were harvested from a small lipoaspiration and then manufactured in an FDA-inspected laboratory. The cells were quality tested and then released back to the physician investigator for injection. Each patient also had a sample of their cells stored at PSC for possible future use. This cell banking offering is a key component that will allow patients access to their cells for other approved studies without any further fat collection.
Dr. Harman stated, “Despite the challenges resulting from a global pandemic, we are proud to have reached this milestone in our first FDA-approved clinical trial. This data supports our progress in the larger placebo-controlled clinical study.”
Learn more in this video below about Personalized Stem Cells and Dr. Harman’s story of innovation which is shaping the future of Evidence-Based Cell Therapies, offered in the Midwest by Dr. Mitchell Sheinkop — selected as one of PSC’s trial centers.
Currently Screening Patients | Next Stem Cell Clinical Trial
The above is paraphrased from a PSC press release of March 30th, 2021. We are currently screening patients interested in the next Placebo-Controlled Stem Cell Clinical Trial. Interested patients may schedule an appointment by calling (312) 475-1893 at either my Chicago or Mt Prospect office. You may learn more by visiting my website at www.sheinkopmd.com.
Last weekend, I was pedaling my bike along State Highway 131 in Wisconsin, between Viola and LaFarge, when I was reminded by a warning sign of the number of recent requests from patients regarding their shoulder symptoms and limitations. After the year-long hibernation, people are waking from their slumber to swim, play golf, play tennis, return to a fitness routine, sail, fly fish, etc., all dependent on a functioning shoulder.
The shoulder is a unique joint in that it enjoys the widest range of motion in the body. Actually, two joints are at the shoulder. The glenohumeral joint is the ball and socket junction of the top of the arm bone and the socket of the shoulder blade. A second joint is the junction of the collar bone with the shoulder blade, called the acromioclavicular joint. Owing to the relative degrees of freedom at the glenohumeral joint, evolution resulted in the rotator cuff, shoulder capsule, shoulder labrum, and shoulder muscles to provide stability and function. All was going well with phylogeny until humans starting walking on two legs. As a result of ontogeny, I now am faced with determining if a shoulder impairment is related to the joint, the rotator cuff, the capsule, the labrum, the bone, or the muscle and tendons. In addition, referred pain from your cervical spine and related nerves is not uncommon.
Shoulder Pain | Altered Function
Let us assume that you present with a chief complaint of shoulder pain and altered function. After completing the medical history including symptom onset and chronicity while learning of any co-morbidities, a physical examination is completed. What follows is a routine X-ray and an MRI if indicated. Once the diagnosis is established, treatment options are addressed by an informed consent process. The three major categories of care fall under operative, biologic, and non-intervention depending on the diagnosis and patient preference.
Space in this Blog does not allow me to address each and every shoulder abnormality; for the purpose of discussion, assume that you are presenting with shoulder symptoms and altered function of longer than six weeks duration. In the aforementioned setting, treatment is mostly elective based on the diagnosis. In some, surgery might be indicated; in others, especially when the problem is in a non-dominant extremity, no intervention may be the patient’s choice other than a course of Physical Therapy and NSAIDs.
Over the last several years, the needle rather than the knife has become a very viable therapeutic option allowing for treatment with Platelet Rich Plasma, Growth Factors, and Bone Marrow Concentrate containing PRP, Growth factors, Precursor Cells, and Adult Mesenchymal Stem Cells. Biologics are safe, effective and yours providing both anti-inflammatory and regenerative potential.
Cell-Based Therapies | Using a Needle and NOT a Knife
Don’t pass up the opportunity to be rendered symptom-free and enjoy the restoration of shoulder function with a relatively short-term rehabilitation. Call(312) 475-1893 to schedule your consultation. You may continue learning more at my website: www.sheinkopmd.com.
This is a cytokine that may neutralize some of the breakdown molecules in degenerating joints. It is found in the circulating blood plasma. There is a centrifuge on the market that can concentrate Alpha 2 Macroglobulin (A2M) from blood, and many doctors who use it like it. As a result, we will run a trial to try it out. The first patients will receive the injection on Wednesday, July 22nd. It will be available for interested patients on a fee for service basis as A2M is not covered by Medicare or private indemnification. The medical claim is that A2M will eliminate pain and improve function in an arthritic joint. It is not new and has been around for four or five years; but evidence is accumulating that this growth factor approach will work effectively in certain populations. It is another potential alternative to surgery that we will soon offer in our office, so stay tuned.
What are Exosomes?
Exosomes are being heralded as the next frontier of cell therapy. While not being cells at all, they play a vital role in the communication and rejuvenation of all the cells in our body. Science has shown that the cell-to cell communication is important in maintaining a healthy cellular terrain.
Age, chronic disease, environmental factors and genetic disorders can interfere with how our stem cells communicate with other cells, thus disrupting the healing process. Exosomes play a key role in the regulation of these communication processes.
What Is Exosome Therapy?
Research has given us a valuable insight into the practical functionality of exosomes. By exposing the cells of an older organism to those of a younger organism we can see that exosomes from the young stem cells are responsible for rejuvenating the older cells. This healing mechanism can now be used in regenerative medicine; and, is gaining traction in orthopedic conditions such as arthritis.
A degenerative disease comes from a continuous deterioration of cells, affecting tissues or organs. While stem cells are usually responsible for the rejuvenation of the cells, external factors may hinder the stem cells in this function. They may not be able to supply all the information needed. Supporting their function with external exosomes could have a greater positive effect, by providing new pieces of information to support the healing process.
To learn more call (847)390-7666 and schedule a consultation. You may visit my web site at www.sheinkopmd.com.
We certainly are living in changing times and daily uncertainties, but my practice continues. Over the years, I have noted that when there is public angst, I have a bit freer time to review our outcomes. Alfred E. Neuman, the mascot for Mad Magazine during its heyday, had a motto “What, me worry?”; and I try to live by that motto. What I have learned from review of outcomes is that More Is Better; both in the quantity of biologics administered and the number of times repeated over a period of years.
Stem Cells Clinical Trial Update
By the end of July, we will have completed recruiting our Personalized Stem Cells Clinical Trial allotted number of patients. While the Adipose based Stem Cell Trial had started in the fall of 2019, all was put on hold until about a month ago owing to the Pandemic. Our initial observation is that there has been a significant decrease of symptoms and improved function in those who underwent liposuction and the knee intervention prior to the February temporary suspension of the Trial. The hope is that sometime this fall, the PSC Trial will allow recruitment of patients with significant symptoms and limitations generated by bilateral knee osteoarthritic involvement. At the same time, PSC will seek approval from the FDA for permission to expand the number of stem cells available for a patient by culturing.
Regenerative Medicine Update
While all this is taking place, please be reminded that our practice offers several options that have proven successful over time or with repeat procedures. First and foremost is the use of bone marrow derived stem cells, growth factors (cytokines), platelets and precursor cells in the arthritic joint. Many patients have returned both for a repeat intervention after some years or for attention to an additional symptomatic and function limiting joint. The patients, including myself, who have undergone several biologic injections be it proprietary, compounded, platelet rich plasma or the more recently available acellular amniotic fluid, have really benefited from the repeated series.
Last of all, I want to remind the reader that interested patients may access Adipose derived Stem cells outside of the PSC Clinical Trial if interested on a fee for service basis. The advantage of such is that several joints may be treated at the same sitting. In the latter scenario, a mini liposuction is completed and the recovered adipose tissue is prepared for immediate joint intervention via a methodology introduced by Lipogems. The end result of the Lipogems process is micronized adipose tissue; it has become quite popular in several biologic practices around the United States.
If you wish to explore these Regenerative and Orthobiologic options for an arthritic joint or joints, you may visit my web site and access my webinar at www.sheinkopmd.com. Even better would be to seek consultation in my office; you may schedule by calling (312) 475-1893.
In my last blog, I used anecdote and two patient experiences to justify my treatment recommendations.This blog will feature a scientific and statistically significant outcomes study that I will be presenting next week at the Orthobiologic Institute Symposium (TOBI) taking place virtually in Las Vegas, Nevada. Since I am the first author of the study, I will claim an author’s license to paraphrase and attempt to simplify.
Cellular Orthopedic Recommendations
Knee osteoarthritis (OA) increasingly is considered to be a whole-joint disease, of which degeneration of the 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. Compounding the treatment of OA is the slow and usually limited recovery of damaged articular cartilage. Conventional therapies, including viscosupplementation, steroids, physical therapy, and non-steroidal anti-inflammatory agents, have shown some benefit in reducing OA-associated knee pain, and improving quality of life/functionality, at least for some period of time, but lack evidence of regenerative or long-lasting benefits. Orthobiologics such as Platelet-rich Plasma (PRP) and Bone Marrow Concentrate (BMC) also have been used in treating OA, with variable degrees of success. Although most publications concerning treatment of knee OA use an intraarticular (into the joint) route of injection, there are a few recent publications that have described an intraosseous (into the bone adjacent to the joint) route for injecting an orthobiologic.
The current study was structured to assess the safety and potential therapeutic benefit of treating patients with mild to moderate knee osteoarthritis with a split injection of BMC, such that approximately 80% of the injectate was delivered intraosseous to the tibial plateau, and 20% was delivered intraarticular. Each BMC preparation was analyzed for Total Nucleated Cells (TNC), and culture-based Stem Cells.Clinical outcomes were recorded for the Knee Society Score; Lower Extremity Functional -activity-Scale (LEFS); and Visual Analog Scale-pain- (VAS). We also assessed for correlations with patient factors, including cellularity (Total Nucleated Cells) and Stem Cells) and pre-treatment clinical outcome values.
The results reported in this study demonstrate the safety of intraosseous delivery of BMC to treat mild-moderate knee OA. Equally important, study participants reported a mean change in VAS (pain scale) at the 1-year milestone of -2.6, which is slightly larger than the commonly reported VAS of -2.5, suggesting that the treatment protocol resulted in a meaningful decrease in pain out to 1-year post-treatment. The mean change at 1-year of the LEFS (activity) outcome was +15.8 points, which is 2.3x larger than that commonly for LEFS of 9 points, while marked improvements in KSS-Knee and KSS-Function also were observed.
I understand that which I have attempted to explain may be confusing but the results of this trial should be understood. For clarification, call and schedule a consultation (312) 475-1893. You may visit my website and watch a webinar at www.sheinkopmd.com
