“I am sitting here at the office, just finishing the first draft of the clinical study report for PSC-CP-001. I am deeply moved and grateful for the incredible efforts you have all made in advising, enrolling patients, completing data forms, monitoring, and all other manner of work to bring this glimmer of an idea from 2018 to a completed first study in 2020. We overcame the FDA, the reluctance of patients to enroll, and the personal and professional perils of COVID-19 pandemic. Many studies and companies were just shuddered. You all kept the faith and pivoted to Zoom and remote exams, along with the help from FDA to allow us to keep moving. In the midst of all this, we also managed to file a new IND for COVID-19, manufacture the cells, get FDA approval, and start the study (2 patients already treated and high hopes). Honestly, Chris and Sue have been the steady Eddy’s for me assuring you all had the right resources and instructions, and each of the site coordinators are Saints. And Carolyn’s manufacturing crew work OT to make sure we extracted the most cells and had a safe product to ship. And Mike has raised capital and kept the company running including doing an amazing license deal that brought us additional capital to keep burning the midnight oil.
The data is awesome. The cells were safe. Not a single Serious Adverse Event. Great data. In the coming week or two I will shepherd the final report through data analysis, editing, investigator review (yes you get to review!) and final QC/QA review. With final signatures it will go to FDA. Shortly behind this submission will be the request to conduct a full blinded placebo-controlled and randomized trial.”
Bob Harman, DVM, MPVM
CEO, Personalized Stem Cells, Inc.
CEO, VetStem Biopharma, Inc.
Personalized Stem Cell Clinical Trial Updates
In 2021, we also plan quickly to apply for IND (FDA abbreviation for Investigational Device Exemption) for cultured adipose cells for knee arthritis. Later in the year, we plan to apply for Clinical Trials to treat multiple orthopedic conditions including knees, hips and shoulders. More specific information will be posted on this Blog as applications are submitted and/or approved. In the meantime, while you are waiting, our Stem Cell, Platelet Rich Plasma and Growth Factor options are available to relieve arthritic symptoms and improve your functional capacity. While I am waiting for my participation in several of the upcoming trials for hips and knees and hopefully spine, either this week or next, I will be undergoing a proprietary Platelet Rich Plasma /Growth Factor intervention at the knee to enable me to ski in February without restrictions.
To learn more about my treatment options, visit my web site at www.Sheinkopmd.com.
To schedule an office visit, call (312) 475-1893. To stay updated on the Clinical Trial developments, don’t miss reading my weekly Blog
Tags: clinical trial update, clinical trials, stem cell clinical trials, stem cell therapy
“Hello, I thought you would like to know that my stem cell in my left knee has worked. I didn’t expect it to take so long but I have had little to no pain for the past two months. Thank you all again for your care and please advise your patients to be patient! If not for Covid, I would have had knee replacement several months ago. Only good thing about Covid!”
I received this e-mail message of gratitude this morning and I began to think what this patient’s recovery might have been following a Total Knee Replacement (TKR). In the latter scenario, maximum medical improvement is not realized on the average for over six months or longer. Following a Stem Cell procedure, Maximum Medical Improvement may take six months or longer. In the population of patients who undergo a TKR, 40% are left with an incomplete recovery; that is, some pain and a significant permanent loss of motion. In those who opt for the Stem Cell intervention to relieve symptoms of arthritis and improve functional capacity, our data suggest 10% of patients don’t experience satisfaction. Following a failed Total Knee Replacement, outcome, the choices are to accept the permanent alteration of life style or undergo yet a second major surgical procedure; namely, a revision (ouch). Following a Stem cell procedure that doesn’t provide the sought-after outcome, we still offer a needle and not a knife to improve the end results.
Looking back at 2020 and looking forward to 2021, based on observations following our regenerative medicine interventions, I will adjust my post intervention management with a more concentrated Growth Factor/ PRP booster. Our evidence-based results over the past several months using Growth Factors in higher concentrations have been most rewarding. As many readers of this Blog are aware, I am working closely with Personalized Stem Cells, Inc. and the FDA to help launch the next Adipose based Stem Cell Clinical Trial. It is our hope that the Trial will be approved by the end of Q1 or the start of Q2. In the interim, if you are experiencing pain and functional limitation from knee arthritis, consider a Growth Factor /PRP concentrate intervention. While there is an out-of-pocket fee for the treatment to keep you going, ultimately, for those who meet the inclusion criteria for the PSC Clinical Trial, there will be a facility fee but no out of pocket expense for the entire Adipose Based Stem Cell undertaking.
To learn more, follow my website at www.sheinkopmd.com.
To schedule a consultation call (312) 475-1893
Tags: arthritis, arthritis treatment, regenerative medicine, stem cell, stem cell therapy
The feeling? Absolute terror! So many things I thought I could never do again. Walking a mile? It took everything I had to walk 10 feet! Walking on uneven ground? I”ll never be able to do that again! Stairs? Like Mountain climbing with only one leg. Even getting up from a sitting position was a monumental task. I had let my right knee deteriorate much too far. It was so bad that I was ready and denser-ate for a replacement.
My friend saw astonishing results from some of his Business Customers and recommended that I check out they Stem Cell procedure.
With an initial assessment by Dr. Sheinkop, the procedure was done a few weeks later. After the procedure, I walked out with no more pain than when I walked in. A bandage covering 2 small holes in my back, a Band Aid on my knee, and a custom-fit knee brace, to wear for four weeks.
Not hospital stay, no x-rays, no pain killers, no prescriptions, no unnecessary tests, and no depressing stay in a Rehab facility. And, no artificial device.
Progress was slow but steady – two steps forward, one step back.
The Stem Cell Facts
At first, stairs were near impossible. I had a stinging pain in the front of my knee, and a severe limp. After six months, my knee condition improved to about 60%, with therapy and home exercises. The stinging pain had diminished. Stairs were difficult but I could manage up and down while holding on. Limp had improved from severe to awkward.
At the one year mark, my knee was light, stronger, and more flexible – and the stinging pain was gone. Had slight pain while going down stairs, with an improved but still noticeable limp. My self-assessment at this time was 93% There was some anxiety. I read full healing takes about one year. I had no idea that my condition would continue to improve.
It improved dramatically, but not quickly. A year-and-a-half after the procedure, all pain, soreness, and stiffness was gone, my knee was strong and flexible. I did thinks I wasn’t sure I’d be able to do again – kneeling, crawling, walking, running, bicycle riding, jumping, climbing, golf, hockey – too many to mention. I was at 99% and it felt great! The remaining 1% was a slight, but still noticeable limp.
It took another six months for the limp to completely go away. This was two years after the procedure. 100% – back to normal!
For something that sounded too good to be true, the results are there. And, the cost? For me, it was less than the deductible I would have paid for a conventional operation.
One of the best decisions I ever made was to have this Stem Cell procedure done.
Find out if You’re a Candidate for Dr. Sheinkop’s Stem Cell Procedure
Tags: cellular therapy facts, patient testimonials, stem cell procedures, stem cell therapy
Tono-Bungay by H.G. Wells, tells the story of a miraculous cure-all, Tono-Bungay, that is in fact nothing other than a pleasant-tasting liquid with no positive effects. Nonetheless, when the young George Ponderevo is employed by his uncle Edward to help market this ineffective medicine, he finds his life overwhelmed by its sudden success. Soon, the worthless substance is turned into a formidable fortune.
H.G. Wells first published the book in 1909, but he may well have been describing the relatively unregulated market place for the charlatans and camp followers promoting Regenerative Medicine and Stem Cells in 2020. As an orthopedic surgeon with an ethos of helping arthritic patients postpone, perhaps avoid a major joint replacement, I am happy to share the October 14, 2020, press release post: “The American Academy of Orthopaedic Surgeons (AAOS) continues to demonstrate its commitment to advancing the quality of musculoskeletal care in a fully transparent and scientific way. Debuting today as a new member benefit, the AAOS Biologics Dashboard is a dynamic online tool designed to help orthopaedic surgeons navigate the FDA approval status of biologic-based interventions. The development of the AAOS Biologics Dashboard is just one of several efforts within the Academy’s Biologics Initiative that offers evidence-based guidance to the musculoskeletal health community.”
Orthobiologics for the Musculoskeletal System
Orthobiologics is an evolving frontier. As new therapies, such as regenerative medicine therapies and stem-cell injections, become increasingly popular due to their potential to regenerate tissue and enhance bone healing and reduce pain, the AAOS continues to recognize a need for reliable and credible sources, of evidence-based therapies. These new tools further validate my ongoing commitment in separating science from anecdote with the goal of helping my patients receive the highest quality of evidence-based care.
What was to have initially taken place this month, basically a purge of the products not FDA approved in the marketplace, has been delayed until May of 2021. In my practice, I can assure my patient that all care will anticipate the FDA rules and be compliant with the FDA regulatory apparatus by prior screening on the new AAOS Biologics Dashboard. Although there is no board certification for a regenerative medicine or stem cell physician, look for the letters FAAOS after the M.D., as they describe membership in the American Academy of Orthopedic Surgeons and is your protection and quality assurance if you chose to undergo a stem cell or cellular orthopedic procedure.
To schedule a consultation, call (312) 475-1893. My web site is accessed via www.sheinkopmd.com
Tags: cellular therapy, musculoskeletal system, stem cell therapy, treating muscle pain
On Wednesday, I am clinically testing Alpha 2 macroglobulin, or A2M. My first patient is the product distributor; he is my guinea pig. Supposedly the injection will stop cartilage breakdown in joints, promote tissue growth and support the overall restoration of an affected joint; however, before jumping on this latest bandwagon, I want to document safety and efficacy. We have been using autogenous (yours) Platelet-derived proteins and this will be my first usage of an autogenous protein other than platelet derived.
A2M as a Treatment for Arthritis
Scientific evidence points to A2M as playing a role in stopping osteoarthritis at the molecular level. A2M is a Broad Spectrum, Multi-Purpose Protease Inhibitor (powerful chemical in destroying proteins that cause arthritis) that captures and inactivates the three major chemicals that lead to joint breakdown and cartilage damage. Once these bad chemicals are trapped by A2M, the body can then quickly eliminate them. A significant research study out of Brown University, in collaboration with the National Institutes of Health, demonstrated that although the concentration of A2M in the joint is insufficient for joint protection, an intervention with concentrated A2M provides cartilage protection in post-traumatic OA by stopping the progression of arthritis. The results of this study suggest that therapeutic injection of concentrated A2M may inhibit the breakdown of cartilage and shut down the destructive inflammatory proteins in the joint. Additionally, it is noted that early intervention may be critical for preventing or minimizing the development of post-traumatic Osteoarthritis (OA). An injection of A2M during the acute phase of an injury, allegedly is proving to be a powerful tool in preventing progressive arthritis in the affected joints, hence my interest. The A2M protein is made in your liver. Using special binding sites, it will bind and trap bad enzymes that are destroying your cartilage. Once each of A2M’s binding sites is occupied, the A2M and the disabled enzymes are naturally removed by your body.
Due to its large size, A2M cannot make it into the joint in high enough concentrations when required which may lead to chronic pain, and collapse of the joint. It is important to note that A2M is not a platelet product, A2M circulates in the plasma portion of your blood.
To learn more, call and schedule an appointment (312) 475-1893. My website is available where you will find my webinar at www.sheinkopmd.com
Tags: cell-based threatments, stem cell therapy, therapies for arthritis, treatments for arthritis