Due to the Federal District Court ruling in the CSCTC/CSN case in August of this year, it appears that FDA has no jurisdiction in autologous adipose cell therapy, including cell culture expanded cells. Many questions on interpretation so here is the link to the ruling to provide you easy access to read for yourself:
Our office will be communicating with you concerning your interest in pursuing the cultured stem cell option for an arthritic joint.
1. Patients with stored doses ready to use
a) After decision to provide treatment, in conjunction with your patient, you can place an order for the number of doses needed and date to treat.
2. Patients with stored culture starter cells
a) These patients do not have cells ready to use and must place order for cell culture expansion (“StemReady”) to manufacture the cells. Cost for past trial patients is $7,500 and for a new patient is $12,500
Physicians’ invoices for all medical services rendered, including but not limited to lipoaspiration, diagnostics, examinations, office fees, laboratory fees other than PSC, stem cell administration and any additional medical services provided.
PSC directly contracts and invoices the physician’s patients for laboratory processing services and cell banking fees per this schedule.
The Fee Schedule is that of PSC and Stem Ready. There is a professional fee that is additional and generated by my office. For those interested, the fee schedule is far less than what is usual and customary when travelling off shore for Stem cells.
To learn more or schedule a consultation, call: (847) 390-7666. You may visit my web site at www.sheinkopmd.com. The Personalized Stem Cell web site is www.personalizedstemcells.com.
Last Thursday, I stopped doing the talk; I took the walk. As readers of this Blog are aware, I have not been spared from the ravages of aging joints, having enjoyed a very active recreational profile since childhood. My pain generated by the joint inflammation as a result of Osteoarthritis has been held in check by anti-inflammatory meds for the past several years until the internist told me to take a medicinal “holiday”. My most recent laboratory profile suggested potential harm to my kidneys. About five days after having ceased and desisted from the use of anti-inflammatory medications, I was experiencing a significant increase in joint pain and a marked intolerance of my usual fitness and recreational undertakings. Next came the limp and need for a cane. It became increasingly difficult to sleep, dress, and carry out the activities of daily living.
This past Thursday, I received an autologous, biologic intervention to my right hip under ultrasound control. Classified under Platelet Rich Plasma, the product applied after a blood draw from me, and concentrating, then filtering contained A2M (Alpha 2 Macroglobulin), IRAP (Interleukin 1 receptor antagonist protein), and an assortment of the circulating proteins, cells, and extracellular vesicles (RNA messengers) contained in my plasma. Said treatment is compliant with The Practice of Medicine. The procedure was done under ultrasound control, at my office after the patient day was finished. Why I had not chosen to pursue the Concentrated Bone Marrow or Micro-fractured Adipose tissue route has to do with timing and logistics. I still may pursue the latter two options; but let’s see what happens with the first approach. As far as cultured adipose-based stem cells, while available offshore, perhaps in California, the legality outside of California still is not clear.
In response to your question: “how am I responding?”; it took 72 hours but my pain has significantly diminished and I am ready to discard the cane. My work schedule continues without interruption. If I am not asymptomatic and fully functional by Thanksgiving, my plan is a second biologic application; as the scientific evidence clearly documents improved outcomes with repeat injections of biologics.
Should your quality of life be compromised by the symptoms and functional limitations imposed by osteoarthritis, we offer a full range of Cellular Orthopedic and Biologic alternatives. Which alternative is best for you will be determined after an office assessment wherein I gain insight into your medical and orthopedic symptoms and functional limitations. Next will come a review of your X-rays and MRI; then, I will provide comprehensive informed consent about the Regenerative Medicine and Cellular Orthopedic intervention that best serves your needs. To schedule the consultation call (847)390-7666. You may visit my website at www.sheinkopmd.com.
The standard of care in regenerative medicine and cellular orthopedics has been, and continues to be, your Concentrated Stem Cells. My research and resulting evidence continue to support our ongoing clinical focus; whether the stem cells are harvested from bone marrow or, more recently from adipose tissue (fat). Unfortunately, not all patients with osteoarthritis are candidates for a Stem Cell procedure because of co-morbidities or the inability to discontinue certain medications. When we are unable to complete a stem cell procedure for a patient with symptoms and limitations imposed by osteoarthritis, what are the alternatives, and which alternative is best?
When I am unable to harvest your stem cells, I look to your venous blood containing platelets and plasma for that which might control your pain and improve joint function. Filtered and concentrated, the Extra Cellular Vesicles, Proteins, and Molecules in the platelets and plasma provide a possible resource for managing your arthritis. One such resource is A2M (Alpha-2-Macroglobulin), a protein that naturally occurs in plasma blocking molecules responsible for creating arthritis in the body. By harvesting a patient’s A2M and re-injecting the super concentrated A2M mixture into the diseased joint, the progression of arthritis (specifically, osteoarthritis) can be stopped as well as preventing further loss of cartilage while promoting tissue growth and relief from inflammation/pain. Interleukin-1 Receptor Antagonist Protein is another resource but space is limited so I will review IRAP next time.
The problem is that not all joints respond to Platelet Rich Plasma interventions nor is there a predictable time to or duration of response. Remember that the term Platelet Rich Plasma is generic with many available Cellular Orthopedic treatments included under the category: PRP. The best PRP treatment would ideally be determined by a cellular marker. That is a test to identify joints that will likely do well with an A2M treatment. This test is called the fibronectin-aggrecan G3 complex test (FAC). It specifically identifies significant levels of the very specific protein which is highly diagnostic for arthritis.
How It Works
The body naturally produces proteins that degrade cartilage when the joint is injured. A2M is a powerful inhibitor of three specific protein classes that cause cartilage to break down: Cytokines, Matrix Metalloproteinases, and A Disintegrin and Metalloproteinase with Thrombospondin. By blocking these proteins, A2M injections can stop the progression of Osteoarthritis (once those proteins are trapped, the body can eliminate them quickly) as well as support cartilage restoration.
Blood is collected from the patient and then processed using an Alpha 2 Macroglobulin concentrator with a centrifuge and filtration system. The super concentrated amount of A2M is now ready to be injected into the patient’s affected joint using ultrasound guidance.
After the procedure, you may experience minimal discomfort for 3-5 days; then comes experience pain relief in 4-6 weeks. I will monitor you until the return to pre-procedural activities. The regenerative process continues to work over a period of 6 months to a year with most of my patients continuing to improve in function/movement and decreasing in inflammation/pain.
To learn more, visit my website at www.sheinkopmd.com. To schedule a consultation, call (847) 390-7666.
For the past year or so, I have been including in my Blogs, the possibility of a second Adipose Based Stem Cell Clinical Trial sponsored by the same group as the first stem cell trial completed over 18 months ago. Personalized Stem Cells, Inc. (PSC), for whom I served as one of the co-investigators, has been working on submitting a request for approval of a second Trial to the FDA. About six weeks ago, The California Appellate Court ruled that the use of Adipose-Derived and Cultured Stem Cells falls under the practice of medicine and thus does not require FDA approval. Since that announcement, Personalized Stem Cells has requested and received several legal opinions as to how to proceed outside of the State of California.
At this point in time, PSC is still planning to submit a request for the second phase Clinical Trial to the FDA anticipating that the FDA will ultimately take issue with the California Appellate Court decision. That legal process though is slow and may take years. While this is all taking place, PSC has decided to allow patients to access their stored Adipose-Derived Stem Cells. The financial aspects that will govern said usage are to be announced soon by PSC.
In addition, what I learned last week is that the Adipose-Derived Stem Cells of all participants in the initial clinical trial are in storage and may be available for usage as well as for those who initially paid to bank cells; it is a matter of costs and the latter should be announced soon. In my evidence-based clinical practice of Regenerative Medicine for an arthritic joint, I am able to use the entire spectrum of Orthobiologics starting with Platelet Rich Plasma (A2M, IRAP). At times, it would be more appropriate to use Bone Marrow Concentrate containing Adult Mesenchymal Stem Cells in addition to PRP, A2M, and IRAP. There is also a place for micro-fractured Fat Graft-Lipogems, in appropriate patients obtained by a mini-liposuction. More recently, we have introduced a new technology in biologic medicine termed Extracellular Vesicle Therapeutics that holds promise in improving function and reducing inflammation-generated joint pain.
In order to gain a further understanding of the world of Orthobiologics and Cellular Orthopedics, visit my website at www.sheinkopmd.com. Better yet, call my office and schedule a consultation (847)390-7666.
J Bone Joint Surg Am
2020 Mar 18;102(6):468-476.
294 Knee Replacements in a Study Group of 3,417 were deemed “likely” Inappropriate
According to the Journal of Bone and Joint Surgery, it is clinically relevant to ensure that the patient is actually ready for joint replacement surgery to maximize benefits. “Undergoing total knee replacement too early may result in little or no benefit while exposing the patient to the risks of a major operation.” The study further states that waiting too long for a replacement can also have long-lasting problems.
What other options are there when it isn’t time for joint replacement surgery? Platelet Rich Plasma, Bone Marrow Concentration, and Micro-Fractured Adipose Tissue (fat) are available to mitigate pain, regenerate tissues, and reduce inflammation in osteoarthritic joints.
When a Joint Replacement is indicated, there is little disagreement in the Orthopedic Joint Replacement Centers of Excellence regarding the symptoms, limitations of function, and changes on both X-Ray and MRI that will lead to a surgical recommendation. On the other hand, an adverse outcome to a Total Joint Replacement is a difficult challenge for the patient and the surgeon. Infection, failure to regain a functional range of motion, intraoperative fractures or ongoing pain to name a few potential reasons for a failed joint replacement, may be permanent and difficult to treat if not impossible to correct.
In the scientific publication cited above, 8.6% of the population studied did not meet the recognized inclusion criteria for a Total Joint Replacement. I don’t know why the surgery then was recommended or undertaken; but when there is a question, get a second opinion. I have been asked to provide an expert opinion in a failed total hip replacement wherein the patient prior to surgery was playing golf and tennis. The physical findings were consistent with symmetrical hip motion. Because of occasional pain, an MRI had been prescribed and was compatible with acetabular labral degeneration. The preoperative X-ray excluded anything greater than grade 2 osteoarthritic changes. While the patient had sought a possible arthroscopic remedy, the surgeon had recommended a Total Hip Replacement based on the theory that the patient would “probably” develop an arthritic hip in the next five years and then require a Total Hip Replacement. Nine months after the Total Hip Replacement. the patient underwent revision surgery to correct a postoperative leg length inequality of greater than ¾ of an inch. The patient has never returned to golf or tennis. It is more likely than not, an orthobiologic intervention would have prevented the unsatisfactory, life-changing outcome.
To learn more, visit my website at www.sheinkopmd.com. Better yet, call and schedule a consultation at (847)390-7666.