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.
Readers of this Blog are aware of my having been credentialed for the first ever, FDA approved, Clinical Trial allowing the use of stem cells, retrieved from your own adipose tissue, in the care and treatment of arthritis. Until now, although heavily advertised, it has not FDA compliant to separate stem cells from your bone marrow or fat and use the cells for injection into an arthritic joint. Concentration has been allowed but not separation, storage or culturing. Two months ago, Personalized Stem Cells receive FDA approval to credential several centers in the country to begin recruiting patients for a mini liposuction, separation of the stem cells from the fat, and injection of the resulting millions of cells into the arthritic knee. Detailed information is available on my web site, sheinkopmd.com or at the personalizedstemcells.com site. Bad actors and Camp Followers advertised that they could provide stem cells but they were charlatans; as of October 1, Google will no longer run those adds. The truth be known, the only approved means of delivery stem cells was though concentrating your bone marrow after aspiration. Now we have another option, using the stem cells derived from your adipose tissue via a proprietary, patented FDA compliant processing methodology.
As of today, we have screened seven interested patients for The Clinical Trial. It is a complex process and time consuming to make sure that the patient meets the inclusion criteria for The Trial. Then comes the informed consent process which is very comprehensive. The first patient has gone through the Prescreening and the Screening after having met all inclusion criteria; his procedure is scheduled in two weeks. The second patient underwent the Prescreening process and now is completing X-rays and laboratory studies in preparation for the Screening visit. Over the next two weeks, the others will be prescreened, screened, receive comprehensive informed consent; and assuming all requirements are met, scheduled for the procedure.
Future Clinical Trials Under Consideration
- PSC plans to apply for clinical trials to treat multiple orthopedic conditions including knees, hips, and shoulders. More specific information will be posted as applications are submitted and/or approved.
- PSC plans to apply for clinical trials to treat Traumatic Brain Injury (TBI). More specific information will be posted as applications are submitted and/or approved.
- PSC is collaborating with physicians and academic institutions to develop stem cell treatments for medical conditions that currently have few treatment options.
To schedule a consultation in my office, call (312) 475-1893. To learn more about the FDA approved Clinical Trial call (312) 475-1893.
The stem cell industry has seen little regulation in recent years. Unproven and untested treatments are often used in clinics that serve numerous clients because “these clinics operate mostly in the private health care sector and typically market their interventions directly to patients over the internet,” according to the World Health Organization.
Advice for People Considering Stem Cell Therapies
Know that the FDA plays a role in stem cell treatment oversight. You may be told that because these are your cells, the FDA does not need to review or approve the treatment. That is not true.
Stem cell products have the potential to treat many medical conditions and diseases. But for almost all of these products, it is not yet known whether the product has any benefit—or if the product is safe to use.
If you’re considering treatment in the United States:
- Ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. You also can ask the clinical investigator to give you the FDA-issued Investigational New Drug Application number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment—even if the stem cells are your own.
- Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.
Screening and Enrollment Begins- FDA Approved Clinical Trial for Knee Arthritis PSC-CP-001
I am pleased to announce that our clinic is now approved and credentialed for the first of its kind stem cell clinical trial for knee arthritis. For those who are suffering from knee arthritis pain in a single knee, this is a unique opportunity to explore stem cell treatment in an FDA approved research study. This is a tremendous honor since there is a limit often clinics aroundthe country in the clinical trial. Our practice and our professional staff were selected by Personalized Stem Cells due to our leadership and experience in the treatment of orthopedic conditions, and our experience with regenerative medicine.
Personalized Stem Cells, Inc. (PSC) has received approval from the FDA for conducting a clinical trial for the treatment of knee arthritis with stem cells from a patients’ own fat. The clinical trial includes treatment, follow up, and cell storage for potential use in the future if, or when, additional treatments are allowed by the FDA. PSC has FDA inspected facilities, approved processing procedures, quality testing procedures, and cell storage and shipping procedures. More information about the clinical trial can be found HERE.
Call 312-475-1893 if you are interested in being considered for this study and would like to discuss initial screening for your condition to determine if you meet the criteria for this study.
Meanwhile, Google ends stem cell therapy ads due to “rise of bad actors”
By Catie PerryPublished September 06, 2019 Social MediaFOX Business
- Some say the modern version of snake oil is unproven stem cell treatments, and Google is cracking down on these types of treatments advertising on its site: Amniotic Fluid, Cord Blood, Birth Tissues to list a few.
- “A rise in bad actors” prompted Google to update its policy, according to a statement published Thursday by Adrienne Biddings, a policy adviser for Google Global Product Policy.
- “We’re announcing a new Health care and medicines policy to prohibit advertising for unproven or experimental medical techniques such as most stem cell therapy, cellular (non-stem) therapy, and gene therapy. This new policy will prohibit ads selling treatments that have no established biomedical or scientific basis. The new policy also includes treatments that are rooted in basic scientific findings and preliminary clinical experience, but currently have insufficient formal clinical testing to justify widespread clinical use.”
- These “bad actors” can take advantage of and offer untested, deceptive treatments to individuals who are often sick and desperate, looking for miracle cures. The ban will take effect in October and will impact Google’s ad services, including YouTube and ads Google places on third-party websites.
“We don’t stop playing because we grow old, we grow old because we stop playing.”
— Attributed to Oliver Wendell Holmes
This blog is inspired by two consecutive Sunday 40 mile plus bike rides. Another one is planned for next Sunday. By so doing, I am able to avoid the dreadful chaos of day to day news and focus on renewal of body and spirit.
On Tuesdays, I return to my fitness routine so as to best prepare for the next sojourn. Two years ago, none of this would have been possible because of progressive limitations imposed by my hip and knee osteoarthritis. It was in December of 2017 that I underwent regenerative procedures on my knees and January of 2018 when my hips were so treated. Since that time, my only limitation is running but that is attributable to my spine.
The Regenerative Medicine world is about to change; the FDA and FTC are watching. Fast forward to August, 2019 and for those who meet the inclusion criteria in the PSC Clinical Trial, you would not only receive millions of your own stem cells, a quantity will be stored for future use As explained in my last two blogs, the PSC clinical trial is overseen by the FDA anticipating the future of Stem Cell Therapy. Your cells will be reclassified as drug, essentially forcing the stem cell charlatans and camp followers out of practice, actually business.
Unfortunately, up until now, the excitement surrounding emerging stem cell therapy has guided and motivated some patients and health care providers. Stem cell therapies currently used do not contain pure stem cells. Instead, they are a mix of a variety of cells, of which only a very small percentage are stem cells. It is possible that many of these treatments did not contain enough stem cells to help; witness amniotic fluid.
It is also important to recognize that many stem cell therapies now marketed directly to patients are conducted without the required biologics license from the FDA. To make matters worse, some forms of mislabeled stem cell therapies do not contain any living stem cells. Such practices are cause for concern, as these treatments can mislead patients and the public, and delay the scientific progress needed to turn stem cell therapies into cures. When discussing stem cell therapy, it’s important to understand that pure stem cells are not currently available to U.S. patients outside of a clinical research study. We are a first clinical research trial, monitored by the U.S. Food and Drug Administration (FDA), at this time to study stem cell treatment for arthritis.
To learn more, visit my web site at www.sheinkopmd.com. You may schedule a consultation at (312) 475-1893. For more information about the Personalized Stem Cells Trial call (312) 475-1893
House Committee Raises Concerns with FDA Over Stem Cell Products
What prompted this Blog subject matter is an inquiry I received from a colleague concerning the use of Stromal Vascular Fraction (Adipose Derived Stem Cells) as an injection option for an arthritic knee. I know something about this alternative as I am an investigator in PSC-CP-001, a Current Clinical Trial for which we will soon be announcing enrollment. The benefits from participation in this trial is 1) your cells are quality tested before use 2) Processing meets FDA standards 3) The clinical trial is approved by the FDA 4) Storage of stem cells for potential future use without another fat collection 5) treatment is offered in the US.
On July 25, the House Energy & Commerce (E&C) Committee sent a letter to the Food and Drug Administration (FDA) outlining concerns over the slower than expected rate of compliance among manufacturers and providers of stem cell therapies. At least 20 manufacturers and providers who may be offering unproven stem cell therapies have already received letters from the FDA. In 2018, the agency filed injunctions against two clinics to stop the marketing of unproven and unregulated stem cell therapies. Now the FDA has until August 15 to address the Committee’s questions, including how it is coordinating with other state and federal agencies. AAOS continues to monitor the FDA’s actions on stem cells and to share information that helps members comply with the evolving regulations governing these therapies. Read E&C Committee’s letter to the FDA…
The letter from The Congress of the United States, House of Representatives, Committee on Energy and Commerce is a must read -ctrl+click on that in red above will get you there-and you will learn how those victimizing an uninformed public and those uninformed or misinformed physicians will soon pay a severe price. Our Trial to the contrary, Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has received FDA approval for a New Drug (IND) application for use of a person’s own adipose-derived stem cells to treat their osteoarthritis. The first clinical trial, expected to begin in several weeks, uses stem cells as a treatment of osteoarthritis in the knee.
This is the first of several planned clinical trials which will enable qualified PSC-enrolled physicians to provide FDA compliant, regulated quality cell therapy to patients suffering from osteoarthritis. PSC plans to conduct a series of FDA approved clinical trials starting with uses in orthopedics and expanding to other medical conditions in the future.
PSC is working with the FDA to provide alternatives to unregulated, in-clinic stem cell processing and unapproved “regenerative” therapies. The current environment of in-office, unregulated manufacturing of stem cells by physicians has come under serious regulatory action by the FDA, FTC, and the Federation of State Medical Boards. It is clear that the only allowed use of stem cells will be through legitimate FDA clinical trials with manufacturing in a controlled FDA inspected, GMP compliant facility.
I am pleased to announce that our clinic is being considered for enrollment in the first of its kind stem cell clinical trial for knee arthritis.
Personalized Stem Cells, Inc. (PSC) has received approval from the FDA for conducting a clinical trial for treatment of knee arthritis with stem cells from a patients’ own fat. This is a tremendous honor since there is a limit of ten clinics around the country in the clinical trial. Our practice and our staff were selected by PSC due to our leadership and experience in treatment of orthopedic conditions, and our experience with regenerative medicine.
The clinical trial includes treatment, follow up, and cell storage for potential use in the future if, or when, additional treatments are allowed by the FDA. PSC has FDA inspected facilities, approved processing procedures, quality testing procedures, and cell storage and shipping procedures. More information about the clinical trial can be found HERE.
Our office will be receiving additional information in the near future regarding the details of the clinical trial.
Please contact us at 312-475-1893
Call 312-475-1893 if you are interested in being considered for this study and we will put you on the list for when we are able to start formal study recruitment and screening.
Click here to read the press release.