“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
About 15 years ago, an article was published regarding the use of Platelet Rich Plasma for the treatment of arthritis. Prior to that clinical trial, physicians would use hyaluronic acid (rooster comb) in an attempt to diminish the symptoms from an arthritic joint. The introduction of PRP heralded the beginning of orthopedic, clinical Regenerative Medicine. Our problem then was that no clear-cut definition of Platelet Rich Plasma was advanced; even today, there is a lack of standardization of the many available PRP offerings. That being said, I use the term Proprietary PRP to clarify my compounding of your platelets and plasma in controlling the pain generator in an arthritic joint; namely inflammation. Growth Factor Proteins (too numerous to describe here) contained in platelets and plasma, act as antagonists to the pain generators within the joint. When concentrated and injected into the painful, inflamed joint, symptoms disappear or are minimized and function improves.
Continuing with our webinar, it was the introduction of the Adult Mesenchymal Stem Cell into orthopedic practice 12-years ago, following FDA guidelines for clinical use, that allowed Regenerative Medicine to become a reality. At that time and continuing to the present, the possibility of cartilage regeneration in an arthritic joint can only be realized by a combination of stem cells, platelets and growth factors. The classic source of these joint regenerators is your bone marrow. In order to be FDA compliant, the harvested bone marrow must come from you and be concentrated, not expanded with addition other agents or through culturing.
FDA Approved Cell Based Therapy
Fast forward to 2019 when the first FDA approved Stem Cell Trial using adipose derived Stem Cells made available via Liposuction and processing was initiated by Personalized Stem cell, Inc. I was one of the several investigators involved and we are tabulating and analyzing data which will then hopefully allow us to move forward with the second phase of the Trial. While bone marrow gives us access to tens of thousands of stem cells, adipose tissue (abdominal fat) allows us to recover several millions of stem cells for processing and clinical usage. I will announce on my web site if and when the phase two trial is allowed by the FDA.
In the meantime, my practice based on various orthobiologic offerings to relieve symptoms of arthritis and improve functional capacity continues. While cartilage regeneration isn’t always an option owing to age or co-morbidities, such options including IRAP variations, Exosomes, and Proprietary PRP are available to maintain or restore an active lifestyle.
Finally, in part owing to lack of standardization and in part because of the charlatans and bad actors holding themselves out to be Regenerative Medicine “experts”-one can attend a 72-hour course and then upload a web site claiming expertise-The American Academy of Orthopedic Surgeons has initiated reform of the emerging discipline of regenerative medicine with consumer protection and physician continued education as the primary goal. I am a Board Certified Orthopedic Surgeon, Fellow of the American Academy of Orthopedic Surgeons and Fellow of the American College of Surgeons.
Good riddance to the quacks.
Tags: cell based therapy, cellular therapy, regenerative medicine
My goal is to separate fact from fiction by delivering evidence-based care specifically related to orthobiologics, and contribute to biologics knowledge and application in arthritis and orthopedic conditions. At present, too many patients are navigating the field independently without reliable sources of information resulting all too frequently in substandard care provided by non-orthopedic physicians; thus, experiencing unsatisfactory outcomes. I still am an orthopedic surgeon having evolved into regenerative medicine using stem cells, proprietary platelet rich plasma, growth factors, exosomes and acellular amniotic fluid with a needle and not a knife.
September 29, 2020
“Dr. Mitchell Sheinkop
It was a little over three years ago when we first met. At that time, I could not walk through a Walmart without experiencing significant pain in my left knee. Well, since that time my knee has continued to improve. Fast forward to today, we have just returned from our hiking trip to the southwest national parks (Grand Canyon, Bryce, & Zion). This trip included 7 days of hiking that totaled 60 miles with significant elevation changes (pictures included on enclosed DVD).
Hats off to you and your staff as I could not have been able to do this without you”
The patient who sent me this beautiful expression of appreciation had presented to my office seeking to postpone, perhaps avoid a Total Knee Replacement. He had already been treated for several years by a local physician with physical therapy, non-steroidal anti-inflammatory medication, and injections of cortisone and hyaluronic acid to no avail. After assessment and review of images, I provided him informed consent regarding the several options available at the time; he elected to undergo a stem cell procedure using Adult Mesenchymal Stem Cells harvested from his bone marrow. Several days prior to the bone aspiration, a Platelet Rich Plasma injection using the patient’s own platelets was completed to initiate healing. Five days later, the bone marrow aspiration was completed in a surgi-center to assure sterility and the concentrated bone marrow containing Stem cells, Platelets, Precursor Cells and Growth Factors were injected into the patient’s left knee under image guidance. About a week later, a concentration of a proprietary Platelet Rich Plasma filtrate was injected into the left knee under image guidance as well. The result is best described the patient himself in the above message quoted above.
What I have described took place three plus years ago. Since then, the biologic options have increased; in part owing to my clinical research and that is what I want to explore with you in this webinar.
Tags: cell therapy, cellular therapies, evolution of orthobiologics, new orthobiologic treatments
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