In addition to the usual and customary clinical outcome parameters currently in use, my research initiative also emphasizes a responsible approach; incentivizing patient reporting of long-term outcomes. ~ Mitchell Sheinkop, M.D.
The prospect of stem cell and growth factor injections as a minimally invasive treatment to improve patient function and diminish the symptoms of Osteoarthritis is an appealing concept, one that has created significant buzz in recent years, attracting the attention of the national media and scientific community. The relatively novel treatment is predicated on the idea that it may be possible for stem cells and growth factors to influence cartilage cells and repair a previous area of injury while also inducing an anti-inflammatory, pain-relieving effect. However, there are currently no FDA-approved indications for therapeutic Mesenchymal Stem Cell (MSC) injections; such therapy is only allowed in a Clinical Trial. My use of MSC and Growth Factor injections with full FDA compliance for regenerative and functional improvement therapy continues to grow.
Patients who express interest in stem cell therapies must be prepared to pay out-of-pocket costs to receive these treatments within or outside of participation in clinical trials. Additionally, patients seeking MSC and Growth Factor injection therapy must guard against alternative providers who are untrained in orthopedic interventions and are misleading patients with unproven promises of efficacy. By integrating patient care with clinical outcomes research, I continue to meaningfully add to the clinical body of evidence. That’s why I am able to identify as an Evidence-Based practice.
To illustrate the fruits of my research initiative, I will cite two patient-reported long-term outcomes.
Patient number one is in his mid-70s and became a patient nine years ago after he was told that he “needed” bilateral knee replacements for advanced osteoarthritis. He has completed several bone marrow concentrate and growth factor concentrate procedures over the years. On Saturday, I received an email message indicating that he had completed an eight-day, 900-mile bicycle ride around Lake Michigan.
Patient number two, in her early 60s, is someone I began caring for approximately five years ago, after she had been told that there was a need for a bilateral knee replacement owing to advancing osteoarthritis. Having been referred by my niece, the patient’s co-worker and friend, I had the opportunity to personally observe her last night in a social setting. When the dancing at the wedding started, there she was with her husband on the dance floor no matter what the rhythm and genre of the song being played.
The third patient is me; I could have and did dance all night.
If we take into account all the scientific scores in use for following the outcomes of Orthopedic procedures for osteoarthritis, I believe that patient demonstrations and reporting of long-term outcomes is a reliable testimonial for the evaluation of Stem Cells and Growth Factors in Orthopedics.
To learn more, visit my website at www.sheinkopmd.com and that of Personalized Stem Cells at www.personalizedstemcells.com. To schedule your office visit, call (312) 475-1893.
By an Evidence-Based Cellular Orthopedic Surgeon
Memorial Day has come and gone. On May 31, the FDA finally started enforcing many of its rules; and Amniotic Fluid, for the time being, is no longer considered FDA compliant. Gone too are all the other biologic purveyors who did not follow the rules or they are now hustling products without FDA approval, beware. What remains compliant is the use of your stem cells contained in your bone marrow along with the platelets, precursor cells, and platelets housed or produced in your bone marrow. The other generally acceptable category of orthobiologics falls under the classification of Platelet Rich Plasma. The clarification of this latter offering is beyond the scope of this blog since platelets are responsible for a huge network of anti-inflammatory proteins. Should you choose to consult with me, I will be happy to expand on the category of Platelet Rich Plasma.
One orthobiologic category that has not fully been clarified by the FDA to the best of my knowledge is that of Wharton’s Jelly. I am researching and investigating. On the other hand, the FDA rules still apply to the majority of biologics:
1) The cells used must come from you, i.e., autologous.
2) Any cells used may only be minimally manipulated without the addition of outside agents.
3) Any cells used may not be culture expanded.
There are exceptions to the rules and those exceptions are FDA compliant when used in conjunction with an FDA-approved Clinical Trial such as the one for which I was a co-investigator with the first of its kind Personalized Stem Cells Clinical Trial for osteoarthritis of the knee. In the next several weeks, I am anticipating the opportunity to review the Phase 2 Stromal Vascular Fraction protocol to be submitted to the FDA for the next FDA Trial.
I started the first paragraph of this Blog alluding to Memorial Day. Prior to and since May 31, I personally have been cycling, fly fishing, gardening, etc. despite arthritic hips and knees. My lower back is not so great either. What keeps me going and enables me to enjoy an active recreational profile are the biologic injections I periodically receive; the very cells, PRP, and Growth factors that I write about in my Blog. There is so much to explain about my non-operative schedule of care for an arthritic joint with a needle and not a knife that I encourage you to visit my Blog at www.sheinkopmd.com. Better yet, call my office and schedule a consultation (312) 475-1893.
By an Evidence-Based Cellular Orthopedic Surgeon
The Food and Drug Administration has pledged that after May 31, 2021, the agency will broadly enforce requirements that developers of regenerative medicine products — therapies intended to repair or replace damaged cells, tissues, and organs — follow relevant approval rules for new drugs, medical devices, and biologics. FDA’s increased enforcement comes not a moment too soon as hundreds of businesses continue to sell unapproved — and unproven — regenerative therapies directly to consumers, leading to patient injuries.
New research by The Pew Charitable Trusts underscores the need for aggressive FDA enforcement against such businesses and practices. Pew found that from 2004 to September 2020, at least 360 people were reportedly harmed by regenerative therapies not approved by FDA nor offered through clinical trials. The products involved were often derived from cells taken from patients or donated sources, such as umbilical cord blood and placental tissue.
My findings suggest that FDA’s recent efforts to reduce the marketing of unapproved therapies have been helpful but not adequate to protect patients. In 2017, the agency provided a detailed framework and guidance to help regenerative medicine businesses meet product approval requirements and gave them three years to come into compliance. Officials later extended the deadline to May 31, citing the coronavirus pandemic. Over this period, FDA sent letters to more than 350 companies and individual providers, warning that their products may violate the law, and sought legal injunctions against a handful of clinics. Nevertheless, clinics continue to market unapproved therapies, including exosomes derived from stem cells and platelet-rich plasma, which are marketed as regenerative interventions and considered a blood product by the FDA.
Many patients have shown interest in regenerative medicine’s potential to treat disease and heal injuries, but widespread sales of unproven products threaten patient safety and trust. The FDA must enforce the law to eliminate the marketing of unapproved products and weed out the charlatans, camp followers, and prostitutes; and ensure that developers of cell- and gene-based therapies conduct clinical trials to demonstrate that their interventions are safe and effective. That’s why I elected to participate in the Personalized Stem Cell first of several FDA-approved Clinical Trials for adipose-based stem cells in knee arthritis, Visit www.PersonalizedStemCells.Com. These steps will help FDA more efficiently root out risky products and foster a safer regenerative medicine marketplace for patients.
To learn more about my Evidence-Based orthobiologic practice, you will find my website at www.sheinkopmd.com or call (312) 475-1893 to schedule an appointment.
From Upcoming Treatments to Treatments Yet to Come
On Saturday, I graduate into yet another decade of my life’s journey. In this Blog, instead of looking back, I will look to the future.
The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative medical products. Products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases such as osteoarthritis.
The agency intends to exercise enforcement discretion with respect to the FDA’s investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products on May 31, 2021. This compliance and enforcement discretion policy gave manufacturers time to determine if certain requirements apply to their products, and if an application is needed, to prepare and submit the appropriate application to the FDA.
They are now reaffirming the timing of the end of the compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies.
Despite all of the FDA’s efforts to engage the industry, there had continued to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions. Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements. The wide extent of the marketing of such unapproved products is evidenced by their inappropriate advertisement in various media and by the number of consumer complaints about them submitted to the FDA.
Regenerative medicine products are not without risk and are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they haven’t been adequately studied in clinical trials. There is no room for manufacturers, clinics, or health care practitioners to place patients at risk through products that violate the law, by not having an IND in effect or an approved biologics license. The FDA oversight of cellular and related products has included taking compliance actions, including numerous warning and untitled letters, and pursuing enforcement action for serious violations of the law. I for one, welcome these actions.
I encourage the public and patients who are considering treatment with regenerative medicine products to work with me to learn about the treatments offered. Ask questions and understand the potential risks of treatment; I do not offer unapproved products. It is critical to only seek treatment using legally marketed products, or, for unapproved products, to enroll in our clinical trials under FDA oversight. The public can visit the FDA’s website to find out if a particular regenerative medicine product is approved.
My website: www.sheinkopmd.com is a continuing resource, as is https://personalizedstemcells.com.
I am committed to helping advance the development of safe and effective regenerative medicine products, including stem cell-based products, to benefit individuals in need. As an Evidence-Based Cellular Orthopedic practice, I look forward to working with you. To schedule an office visit, call (312) 475-1893.
On May 31st of 2021, the FDA will finally bring clarity, hopefully, to the discipline of Regenerative Medicine by enforcing the rules and regulations initially announced in the fall of 2017. With said enforcement, I hope and pray that there will be a restoration of FDA oversite and elimination, or at least diminution, of the charlatans, camp followers, and prostitutes who have held themselves out to provide approved and regulated biologic interventions for an osteoarthritic joint without evidence-based scrutiny or appropriate training and credentialing.
Because of the promises inherent in stem cell therapies, opportunists took advantage by offering cures for arthritis and cartilage regeneration for “bone on bone” when in fact there was not a scientific chance of that happening. What we do know is orthobiologics will block pain in an inflamed joint for a period, that is still being studied and defined. What we also know is that orthobiologics will reverse the inflammation that generates pain in an arthritic joint leading to improved function and a lessening of symptoms. In a younger patient, there is a chance of cartilage regeneration and those chances decrease with age. What is not clear is the duration of effect of the several orthobiologic FDA-approved options. Some of my patients have experienced years of benefit and continue to improve years after the intervention. Our evidence-based outcomes surveillance and research suggest some patients who experience initial relief will report the return of discomfort in months or several years after an intervention. Only outcomes monitoring will help us finally determine the best approach for the needs of a particular patient.
As readers of this Blog are aware, I have been a co-investigator in several FDA monitored Stem Cell Trials to date and am presently involved in the planning of a third FDA Trial. While actively participating in the evolution of stem cell management of the arthritic joint, I have not lost sight of those I have treated who are either disappointed with an outcome or are experiencing a return of symptoms and limitations within 18 months of a biologic injection. If you fall into this latter category, call for a return visit as we have identified an updated solution that will minimize any out-of-pocket expenses outside your healthcare benefit plan.
To learn more about our Cellular Orthopedic practice, visit my website at www.sheinkopmd.com. For an office consultation, call (312) 475-1893. You may follow our progress with the FDA approval of the next Adipose Based Stem Cell Clinical Trial at www.personalizedstemcells.com.
We Treat the Causes
Limited treatment options for Osteoarthritis exist, and the current therapies are all palliative. They only address the symptoms but fail to address the root cause: cartilage damage from the activity of degradative enzymes (proteases) that destroy the arthritic joint. That’s why we use novel treatments to operate at the molecular level. Successful treatment must combat the degradative enzymes at a molecular level.
Standard Non-operative Treatment Options
- Non-steroidal Anti-inflammatory Drugs
- Hyaluronic Acid Injections
- Corticosteroid injections
- Physical Therapy, Weight Reduction, Bracing
- Temporary symptomatic relief
- Treats the symptoms, not the cause
- Many side effects
Hip Intervention for Osteoarthritis | Evidence-Based Care
By chance, while I was writing the Blog this morning, I turned on my computer and found this greeting on the five-year anniversary from a patient who had undergone a Bone Marrow Concentrate/Stem Cell/Growth Factor hip intervention for osteoarthritis.
“Have to say from year four to five no deterioration. In fact, maybe feeling a bit better.
– Still maintaining a daily self-initiated PT regime for leg strength. That soreness (uncomfortable) mostly right below the knee cap and back of pelvis seems to have dissipated.
– Finally developing a normal gait.”
I will let the facts speak for themselves:
The above record was executed by the patient; and thus, objective. It is our means, in part, of documenting outcomes on a continuing basis of the patients we treat; thus, allowing us to lead the Midwest in evidence-based regenerative medicine and Cellular Orthopedics using biologics and not a knife. Then, there is the topic over which I am continually queried, “how soon will I improve and how long will it last?”
When treating an arthritic joint with biologics, the partial improvement may be immediate, or maximum medical improvement may take months, perhaps years. If you want to avoid a knife for an orthopedic impairment, call (312) 475-1893 to schedule your consultation. You may continue reading more at my website: www.sheinkopmd.com.