Jan 8, 2021
“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
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
Apr 30, 2020
Or: Why the Vice President “I tested negative” should wear a mask
Types of Testing for COVID-19 Immunity
There are two types of COVID-19 tests: molecular and serological. Molecular tests (PCR) look for the presence of a virus’s genetic material, showing that there is an active infection. Those are the tests that require a swab to be shoved through the back of your nose and into your throat to collect a specimen. While the Molecular PCR test has a higher rate of sensitivity than the serological, it will only show infection, not if the person has the IgG antibody. The IgG antibody is present after a person had the COVID-19 virus and successful fought off the virus, hopefully having immunity now. Serological tests (Rapid Antibody) look for antibodies to the virus in the blood, the presence of (IgG) which indicates there was an infection in the past. It will also show the (IgM) antibody which demonstrates the person is currently infected with the virus and fighting off the infection.
While the molecular tests (PCR) for COVID-19 have been around since the beginning of February, serological tests weren’t authorized until April 1. Many people see these tests as a way to prove immunity against the virus, allowing those who test positive and possess the IgG antibody “only” to resume their normal lives, free from the threat of contracting the virus again. We don’t yet know for sure that these antibodies confer immunity, nor for how long that immunity lasts if they do, but past history of SARS infections, people who possessed the antibody after successfully fighting off that infection had built up immunity for 2-3 years. Enough time until a vaccine is developed for COVID-19.
If a test identifies individuals who have the IgG antibody, it means they successfully fought off the virus and may have immunity if they were to come into contact with someone who has the COVID-19 virus, or when the virus comes back in the Fall. Additionally, it will show who currently has it and if their body is fighting the virus off, the IgM marker. IgG is the more important antibody class, since IgM secreting patients might not seroconvert. IgG positive patients doesn’t mean they can’t be reinfected- the jury is still out on that one.
COVID-19 and Comparative Religion
On a lighter note, long ago at the University of Illinois in Urbana/Champaign, once I had been accepted to Medical School, after having completed a very intense, mandatory, at the time premed curriculum, I decided to seek an education and, took a course, in Comparative Religions. Most immigrants and their first-generation American children grew up in relatively closed communities; it was time for me to see the world. Below is a teaching that might have, or could have, come from that course:
When it comes to the prohibition of eating bats, it seems the Torah repeats the prohibition not just once but twice. Regarding the Hebrew word tinshames (Leviticus, 11:18), Rashi says “it resembles a mouse and flies about at night.” Clearly, a bat.
Then, just one verse later, the Bible prohibits the consumption of an atalef, which is also translated as bat. Is this a biblical warning against the dangers of eating these creatures?
Tags: coronavirus immunity, COVID-19, covid-19 immunity, covid-19 testing, immunity and testing for COVID-19
Mar 10, 2020
On Thursday, a report appeared in the South China Morning Post that reviewed the case of an elderly woman in an Intensive Care Unit in China. She had been there for two weeks and her organs were clearly failing, so the Chinese doctors got approval to use stem cells that had been culture expanded in the lab. After the first two treatments and within days she was able to get out of bed; and then after the third injection, she was able to leave the ICU and was found to be COVID-19 (Coronavirus) negative.
Another study is underway in Hunan province using similar stem cells and the doctors there were quoted as observing similar results. All of the doctors are saying that it’s time to accelerate the stem cell approach in the care of critically ill patients. These are not the same Stem Cells as your Chiropractor or Naturopath advertises; absolutely not, don’t be misled. Per the report from China, the type of cells used in the first patient were isolated from umbilical cords and then grown in the lab. These cells in China were confirmed as highly viable and functional as this was tissue taken from the OB Ward directly into the lab to be isolated and grown. It was not the non-viable tissue being sold and promoted as umbilical cord-derived “stem cells” here in the US. Those Chiropractic products, based on the research now from many labs, actually contain dead and non-functional stem cells.
How do the Stem Cells work in the face of a Coronavirus infection? What often kills people with the flu is the massive inflammatory reaction in the lungs. This causes swelling and reduces the ability of the lungs to oxygenate tissues. Living stem cells reduce and eliminate inflammation. In addition, stem cells have been shown to be antibacterial and anti-viral. For those who meet the inclusion criteria allowing participation in our FDA Approved Personalized Stem Cell Trial for knee arthritis, there is an option for cell storage. Not only will we use your Adipose Derived Stem cells now for treatment of an arthritic knee, PSC is offering a storage option for future use of those stem cells for anyone of a number of inflammatory conditions.
To learn more, visit my website at www.sheinkopmd.com. The Personalized Stem Cell website is www.personalizedstemcells.com. To schedule an office visit call (312) 475-1893. For those wherein I conclude an arthritic affliction is better managed by bone marrow concentrate containing stem cells, we are now offering a storage option as well.
Call to Learn More
Tags: coronavirus infections, COVID-19, stem cells to treat coronavirus, treating coronavirus
Feb 11, 2020
This past Sunday morning, I was reading the Chicago Tribune sports section to learn about the pundits’ opinions regarding the basketball game played by Duke and North Carolina on Saturday night, one of the most amazing basketball games I have ever seen, (incidentally, Auburn versus LSU was great, as well) when I came across the Golf Headline “Mickelson’s short game pays off big”. Why my interest? Phil Mickelson has psoriatic arthritis controlled by TNF-Alpha blocker, a Growth Factor. Another golfer whose career was restored by Growth Factors is Tiger Woods. In Woods’ case, he had received Platelet Rich Plasma (PRP) with Growth factors; Platelets produce those biologic agents. Then there is the story of Kobe Bryant, who had traveled to Germany in 2012 to extend his professional career for seven years with Interleukin One Receptor Antagonist Growth Factors recovered from circulating blood. At the time, Bryant travelled to Germany, the treatment he was to receive was not FDA approved in the United States. There is now an innumerable list of professionals and amateurs who have returned to the game or prolonged a career through Growth Factors thanks to the recreational impact of biologics.
If you surf the internet for Regenerative Medicine and Biologic alternatives, you encounter the term “Stem Cells”. The reality is that as of this time, there is no FDA or legal way to avail yourself of Stem Cells alone; the only access is by concentrating your bone marrow and injecting the concentrate into the arthritic joint since there are Adult Mesenchymal Stem Cells in your bone marrow.
Concentrated Platelets, Growth Factors, and Concentrated Bone Marrow have been the regenerative and restorative mainstays in my practice until now.
Looking to the future, because I have been involved with several Cellular Orthopedic Clinical Trials over the past five years, my practice is assisting in the creation of pathways for yet another biologic trial in 2020. Most exciting is the FDA approved Personalized Stem Cell Clinical Trial in which ours is one of seven designated and FDA approved centers. The PSC FDA-approved Clinical Trial was launched in August of last year. In September of 2017, the FDA warned that by November of 2020, all biologics would be reclassified as drugs. Personalized Stem Cells was granted FDA approval to create a drug from your own adipose tissue. The abdominal fat is recovered by Liposuction and processed in a facility that has met all FDA and Good Practice Management governmental requirements. The resultant Stromal Vascular Fraction (Stem Cells recovered from fat) number in the tens of millions and are made available for injection into an arthritic knee. You may learn more at WWW.PSC.Com or on my web site www.SheinkopMD.com. To schedule an appointment or consultation, call (312) 475-1893
Tags: biologics, orthobiologics, recreational impact of biologics
Jan 7, 2020
This excerpt is taken from the full article, which can be read here. Copyright © Mitchell B Sheinkop and Maxwell Dordevic,2019,
Abstract
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.
Excerpt
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
