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.
Evidence-Based Cell Therapies | Personalized Stem Cells
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 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.
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.
“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
Following injury to the articular surface of the knee, measurable changes in the joint microenvironment can occur, including altered expression of proinflammatory cytokines, matrix metalloproteinases (MMPs), aggrecanases, growth factors, and apoptotic factors. A study assessing the impact of 10 synovial fluid biomarkers at the time of knee injury found that three specific biomarkers can predict with moderate accuracy functional outcomes and level of pain postoperative at five years.
The development of post-traumatic osteoarthritis (PTOA) affects a large percentage of patients with anterior cruciate ligament (ACL) tears, meniscus tears, and other knee injuries. Even when an injury is surgically treated, the joint is at a significantly increased risk of PTOA five to 10 or more years following the initial insult. It is believed that the accelerated cartilage degradation associated with PTOA is the result of inflammatory chemokines released into the joint space at the time of injury. In other words, the initial seed of post-traumatic osteoarthritis is planted at the time of the injury, and there may be a specific pattern of molecular biomarkers in the synovial fluid (i.e., an inflammatory phenotype) that is able to predict which patients are at the highest risk of diminished function and development of OA as a result of their knee trauma.
Cellular Therapy to Prevent Osteoarthritis After Knee Surgery
The study prospectively enrolled 39 patients (mean age at time of surgery, 41.56 years) undergoing primary knee arthroscopy for ACL injury, meniscus injury, and/or focal chondral lesion beginning in October 2011. Patients were excluded if they had any additional associated ligament injury, systemic inflammatory disease, autoimmune disease, intra-articular corticosteroid injection in the three months before surgery, prior knee surgery, immunomodulatory drug use, chemotherapy within the past year, insufficient synovial fluid aspiration, or cartilage/meniscal transplantation in addition to arthroscopy. Those aged 18 years or younger also were excluded.
Immediately prior to surgical incision, synovial fluid was aspirated from the operative knee and transferred to sterile tubes containing a protease inhibitor cocktail solution. Researchers assessed the concentration of 10 cytokines and chemokines that have previously been suggested to play a role in cartilage degradation and inflammation in the joint space.
Among 28 patients who did not undergo further surgery since the time of synovial fluid sampling, the biomarkers MMP-3 (a proinflammatory enzyme), TIMP-2 (an anti-inflammatory inhibitor of MMPs), and vascular endothelial growth factor (an angiogenesis-inducing growth factor) most accurately predicted functional outcomes at five years postoperative or injury. These findings support my recommendations for use of Bone Marrow Concentrate, Proprietary Platelet Rich Plasma, Stem Cells or Growth Factors following knee injury or arthroscopic knee surgery to postpone, perhaps avoid a Total Joint Replacement
To learn more, visit my web site and watch my webinar at www.sheinkopmd.com
For a consultation call (312) 475-1893
Tags: Cellular Therapy for knee pain, joint pain, knee health, knee pain, knee surgery
At times, my blog is based on statistically documented evidence concerning Cellular Orthopedic interventions. To date, that’s how I treat patents, evidence based regenerative medicine. This time though, I found an unsolicited testimonial so compelling that I am using it as the “center fold” of the Blog this week. The quote is from a 71 year-old patient.
“I wanted to give you the update on my knee condition after having the Alpha2Macroglobulin (A2M) injections about 3 weeks ago. Yes!! Yes!! I’m really loving it. I was reluctant to push it the first 2 weeks because I was enjoying the pain-free analgesic effect. Last week I was in Southern California on the beach and was trying not to overuse it. My knee is very arthritic and whenever I overdo it, I would be in discomfort for days afterwards. I didn’t want to be in pain or nursing my knee with an ice bag while on vacation so I took it easy at first. Easy went to being very active including biking, hiking and bodysurfing in the ocean. My knee never swelled or became uncomfortable. I still have an arthritic knee but I can do whatever I’m comfortable doing with no negative effect. Also sleeping at night without pain is wonderful. I’m very pleased with the way my knee is responding to the injections.
Positive Light on Growth Factors
I am the first to call the reader’s attention to the fact that this is a testimonial and not a scientific report. Yet, the value to the reader is an opportunity to fantasize about how your life might be impacted by cellular orthopedics interventions and thereby, delay, perhaps avoid a major surgical procedure. While stem cells are commonplace in the world of marketing for the arthritic joint, people are still learning about the benefit of growth factors. A2M is what the patient is alluding to in his testimonial, a large protein produced by the liver. It differs from most other growth factors by virtue of molecular size and source of production in that most growth factors are found in the circulating blood. I offer this biologic option to patients who I think will benefit as part of my scope of Cellular Orthopedic options, especially when I do not believe the patient is a candidate for a bone marrow concentrate intervention.
To learn more, you may access my website and view my webinar at www.sheinkopmd.com. A better alternative is to schedule an I office visit wherein I can examine you, review images with you, and provide informed consent; that is patient education. Call (312) 475-1893
Tags: Growth Factors, orthobiologics, patient testimonial