Feb 2, 2018
For those who may have missed it, I was featured Monday night in a Fox 32 news report presented by Fox News investigative reporter Sylvia Perez.
http://www.fox32chicago.com/health/customers-warn-that-doctors-are-scamming-patients-with-fake-stem-cell-claims
Regular readers of my Blog are aware of the opinions I have frequently expressed regarding the charlatans and camp followers that have taken advantage of the regenerative medicine marketplace promising to cure arthritis, Alzheimer’s, Alopecia, ALS, Autism, and every malady known to mankind finally ending at the letter Z. They don’t exclude spinal cord injury, residuals of stroke nor ED while they are at it. The message regarding what stem cells can do is found in newspaper ads, television commercials and radio spots, the latter in the Chicago listening area by a well-known sports announcer. Either attend a seminar or make an appointment for treatment; they will cure your disease, eliminate pain and do away with your suffering. “Call now to schedule an appointment”.
For a free lunch and without an evaluation or examination, you can undergo an amniotic fluid intervention that is “regenerative” as it is claimed, at a cost in the neighborhood of $5,000. I have been involved in amniotic fluid clinical trials for four years underwritten by the largest provider of amniotic fluid in the nation; and our first statement to participants in these clinical trials, without charge for the injectate, is that there are no living stem cells in the amniotic fluid once processed, sterilized, frozen and fast thawed for usage. Hold on, there is more. On September 16, 2017 the FDA published mandatory guidelines: any and all regenerative agents must be autologous and homologous. In plain speak the injectate must come from the same patient and be used as nature intended. Stem cells from donor sources are not compliant.
Featured in the Fox News special report are two patients. One had undergone a complete medical history, physical examination and skeletomuscular evaluation prior to his Cellular Orthopedic intervention enjoying a marvelous outcome; the other, an amniotic fluid injection into his knee without any prior evaluation or preparation and an awful end result. You may watch the actual report by clicking on that underscored above.
One of the standard of practice methodologies in which we take great pride and which I believe separates us from the madding crowd of regenerative medicine camp followers and charlatans; is our evidence based cellular orthopedic approach. In preparation for a scientific podium presentation in two weeks, we are collating our outcomes data at one year for patients who underwent a combined intraarticular (into the knee) and intraosseous (into the subchondral bone) autologous bone marrow and growth factor intervention for osteoarthritis grades two and three. At six weeks, we recorded a 22% improvement in pain relief; 42% at six months, and 89% at 12 months. In future blogs, I will breakdown the outcomes data further and expand on our documented outcomes based on our several cellular orthopedic options.
To learn more, you may review my web site and watch my webinar at www.ILcellulartherapy.com
You may schedule a consultation by calling (312) 475-1893
Tags: autologous proten, bone marrow, C-SCP, cellular orthopedics, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, FDA, Growth Factors, Interventional Orthopedics, joint replacement, Knee Pain Relief, Osteoarthritis, Platelet Rich Plasma, Subchondroplasty
Dec 6, 2017
On November 16, 2017, The FDA posted definitive guidelines concerning what meets minimal manipulation rules and regulations and what is accepted under the practice of medicine guidelines in the specialty of Regenerative Medicine. The FDA further restated the requirement that regenerative medicine be governed by homologous use. As I interpret the guidelines there are winners and losers:
Winners
Physicians who use compliant regenerative therapies:
- Amniotic fluid without stem cells
- Blood-derived preparations (e.g., PRP, PPP)
- Bone marrow aspirate
Losers
Physicians who use non-compliant regenerative therapies:
- Adipose tissue-derived materials obtained by enzymatic digestion
- Amniotic fluid with cells Cord blood derived materials (non-autologous treatments)
- Stem Cell Clinics that advertise about using amniotic fluid as a source of stem cells and regenerative therapy along with those clinics that treat everything from alopecia to ALS to arthritis
You might ask how is that different from the current situation? First of all, the FDA Commissioner has stated in press releases that the FDA is going to go after bad actors. The Cures Act provided for increased funding to the FDA, which we suspect the Commissioner will use in part to go after the bad actors. Also, the FDA wrote in their Guidance on Minimal Manipulation and Homologous Use that “healthcare providers” need to pay attention. We have never seen them explicitly refer to the doctors and clinics providing regenerative medicine. Finally, the FDA indicated that there would be a transition period (3 years) during which manufacturers would need to enter the RMAT program to get their non-compliant products properly approved; or else. And the reason that there could be teeth in the “or else” is that the FDA will get lots of fees from all of the non-compliant products entering the RMAT program.
Last of all, what the FDA did not address as part of consumer protection; but what I incorporate in my daily practice is evidence based intervention.
Now that you are better informed and have an idea as to the laws governing our regenerative medicine marketplace, stay away from the Charlatans and Camp Followers. Then take the next step and ask your physician for the Outcomes Evidence on which a regenerative intervention for your arthritic joint is based before undergoing a procedure. To better understand that evidence call for (312) 475 1893 to set up a consultation
You may watch my webinar by accessing my web site www.ilcellulartherapy.com.
* Minimal Manipulation and Homologous Use
Tags: adipose tissue, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Mesenchymal Stem Cell, Minimal Manipulation and Homologous Use, Orthopedic Care, Orthopedic Surgeon, Platelet Rich Plasma, PRP, regenerative therapies, stem cells
Jul 20, 2017
We now are approaching five-year outcomes regarding the use of Bone Marrow Concentrate for Osteoarthritis of the hip, knee, shoulder and ankle. Bone Marrow contains Adult Mesenchymal Stem (MSC) cells and Growth Factors. In the beginning, the entire informed consent process focused on the MSC in bone marrow as the agent responsible for diminishing pain, improving motion, stopping, at times reversing the progression of osteoarthritis, and potentially regenerating the joint itself. Now we know that equally important to the MSC are the growth factors produced and stored in the bone marrow. Some of the key proteins (Growth factors) include Interleukin-1 Receptor Antagonist Protein (IRAP), Alpha-2-Macroglobulin (A2M), fibrinogen, PDGF, VEGF, and TGF-B to name a few.
The reason we directed our clinical initiatives to Bone Marrow Concentrate is that while Amniotic Fluid contains Hyaluronic Acid, once harvested, sterilized and fast thawed for clinical application, there are no living stem cells left, so Amniotic Fluid Concentrate has no regenerative potential. When it comes to Adipose Derived Stem Cells, in order to liberate the stem cell from the adipocyte, an enzyme, collagenase must be employed. The latter is not approved by the FDA. Additionally, there is no evidence of Growth Factor content in adipose derived tissue.
While I have blogged about the superiority of Bone Marrow Concentrate over all other non-surgical approaches for arthritis, the introduction of the intraosseous adjunct, subchondroplasty, is resulting in even superior outcomes when compared to those who were treated prior to this contemporary version of Cellular Orthopedics. It has been nine months basically since I started injecting Bone Marrow Concentrate into the marrow adjacent to the joint in addition to the intraarticular approach. We already are seeing a better outcome in those who availed themselves of the Intraosseous adjunct. Up until eight weeks ago, my ability to offer contemporary and improved treatment options was limited by preexisting contractual obligations; but now unrestricted, I have expanded my scope of offerings including elevation of subchondroplasty from a clinical trial status to usual and customary adjunct standard of practice option. As well, I now offer an increased opportunity for participation in other clinical trials for the arthritic joint when a patient meets obligatory inclusion criteria determined by the trial sponsor.
If you want to postpone, perhaps avoid a major surgical replacement for an arthritic joint, call for a consultation 847 390 7666
You may visit my web site at IlCellulartherapy.com where you may watch my webinar.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Microfracture surgery, Orthopedics, Osteoarthritis, Pain Management, stem cells, treatment
Jul 7, 2017
There has always been a category of patients for whom Bone Marrow Concentrate derived stem cells and growth factors were not a viable option. Patients who have received or are receiving chemotherapy, radiation therapy or immunosuppression have diminished stem cell viability and actual numbers. Such patients have historically been denied cellular orthopedic intervention; at the same time, they are problematic candidates for a joint replacement. Within the last 18 months, scientific advances are changing the algorithms of regenerative care for patients with symptomatic and debilitating osteoarthritis. I now have several options available for patients who would have been denied interventional orthopedic opportunity; patients who are impacted and limited by Osteoarthritis but for whom there previously was not a viable non-surgical alternative.
1. Alpha 2 Macroglobulin (A2M)
A2M is a very large plasma protein found in blood acting as a very strong protease inhibitor; and for patients who meet certain prerequisites, could well be highly effective in the treatment of osteoarthritis. The prerequisite is a synovial fluid analysis looking for the Fibronectin Aggrecans Complex (FAC). While it sounds complex, it is an uncomplicated testing of a sample of synovial fluid easily preformed under ultrasound guidance in the office setting. Recently, A2M became available in a synthetic recombinant format as an “off the shelf” alternative
2. Umbilical cord derived blood and cells
When our first grandchild arrived, our gift was a regenerative one; namely, the gifting of the cost of freezing her umbilical cord should there ultimately be a need for stem cells in her life. Now, there are scientific and pharmacologic interventions available from allograft umbilical cords retrieved at delivery, sterilized and frozen. It is a new but emerging resource with regenerative and pain-relieving potential for patients with osteoarthritis who otherwise have no other treatment options.
3. Amniotic fluid concentrate
While there are no living stem cells in amniotic fluid once sterilized, frozen and fast thawed, hence no regenerative possibility; the anti-inflammatory effect is real and the pain-relieving potential, although limited in duration, is being scientifically documented. Harvested by amniocentesis at the time of a cesarean section in a donor screened for communicable and infectious diseases, it is possible to repeat the intervention after a year should symptoms return. There are now “off the shelf” preparations of lyophilized Amniotic Fluid Concentrate
4. Bone Marrow Concentrate derived stem cells and growth factors
I am in the in the process of developing a protocol to be submitted for IRB oversite wherein a bone marrow analysis would be completed allowing for stem cell and growth factor analysis pretreatment not unlike a bone biopsy for a lesion prior to the definitive surgery. This would allow me a patient specific approach to those who otherwise would not be considered candidates for regenerative autograft options.
If you want to learn more about postponing or perhaps even avoiding surgery for a joint that alters your quality of life, call 312-475-1893.
To learn more, check out my web site at www.Sheinkopmd.com
View my webinar at www.ilcellulartherapy.com
Jun 26, 2017
Five years ago, I “graduated” from a 37-year career as an orthopedic surgeon with a practice based on hip and knee replacement surgery for arthritic joints. Trading my scalpel for a needle, I entered the new discipline of Cellular Orthopedics with a goal of helping patients delay, at times avoid a joint replacement for the arthritic hip and knee joint. In my transition, I introduced the same integration of research, patient care, and education into Regenerative Medicine that I had pioneered as the head of a joint replacement program at a major-medical center in Chicago, helping that center emerge as one of the five most recognized programs in The United States.
At the beginning and continuing to this day, Cellular Orthopedics has been based on the use of a patient’s own Platelet Rich Plasma and Bone Marrow Concentrate as the source for providing pain relief and functional improvement to a patient experiencing impairment from an arthritic joint. I have almost five years of outcomes data to support my therapeutic recommendations. Platelet Rich Plasma offers healing and pain relieving promise for the patient; while the Stem Cells and Growth Factors in Bone Marrow Concentrate offer regenerative potential in addition, all this while FDA compliant.
Over the past year however, there has been an explosion in the marketing of untested and unproven alternatives continually introduced under the Regenerative Medicine umbrella. Web sites make unsubstantiated claims, purchased media campaigns become a source of false advertising and courses both live and on-line promise expertise credentialing in 48 hours.
As a response to this chaos, I have founded The Center for Orthobiologic Clinical Trials whereby I am able to validate or challenge the plethora of claims and assist my patients in decision making based on scientific evidence; while at the same time, contributing to the emerging discipline of Interventional Orthopedics. I now have gathered the largest Data Base with long term follow-up of which I am aware documenting the Outcomes of Bone Marrow Concentrate, Amniotic Fluid Concentrate and mechanically emulsified, Adipose Derived, Lipogems.
The next step is to study the outcomes of combining cellular orthopedic interventions into the joint with the added step of injecting Bone Marrow Concentrate and Platelet Rich Plasma into the bone adjacent to the joint. I am currently recruiting patients for the latter trial. For those who meet inclusion criteria, there is a discount for said care. Interested patients should call (312) 475-1893 on Monday or Thursday.
If you want to become better informed, browse my website www.sheinkopmd.com.
You may watch my webinar at www.ilcellulartherapy.com or call central schedulaing at (312) 475-1893 for a new patient consultation.
Tags: Amniotic Fluid Concentrate, Bone Marrow Concentrate, cellular treatment, Hip pain, joint replacement, knee pain, lipogems, mechanically emulsified Adipose Derived, Mesenchymal Stem Cell, Osteoarthritis, PRP, regenerative medicine
Jun 15, 2017
It was difficult for me to sit and listen to so many “show and tell” presentations not supported by scientifically overseen outcomes data. Too much anecdote about unproven methodologies; many not compliant with FDA guidance. Basically, it was frequently repeated false news. I was taken aback by what so called physicians are injecting into the joints of their patients. Florida seems to lead the way in the cook book approach to arthritis followed closely by California. Illinois is guilty as well but not the medical community. Despite my negativity about the absence of science, this gathering certainly did not begin to approach the science and integrity of presentation found in the discipline of orthopedic surgery; of particular interest to me was the universal agreement that there is no regenerative potential in Amniotic Fluid Concentrate. A matter of fact, there was not one outcomes paper presented concerning amniotic fluid. It becomes ever so important that a patient choose an experienced, scientifically oriented, regenerative medicine specialist when seeking a non-surgical option for an arthritic knee, hip, ankle or shoulder. The patient must bear in mind that the specialist’s goal is to improve function, diminish pain and postpone, possibly avoid a joint replacement for an arthritic joint. When the arthritis has reached end stage, there are those who should have a joint replacement; only a specialist is equipped to properly advise a patient.
In the orthopedic world, scientific papers are not considered to have significance unless the outcome results have been followed for a minimum of two years and more. Furthermore, the articles in order to be considered authoritative must have statistical significance. It seems that the charlatans and camp followers are offering patients an intervention that is neither FDA compliant nor for which there is scientific outcomes data. The one exception to all the fake news was the presentation by Dr. David Karli of Greyledge Orthobiologics who introduced The Method of Ratios for Assessing PRP and BMC Theraeutic Potential. This novel approach to quantitating and qualitating the injectate I am sure will soon become a standard of care for cellular orthopedics so I will quickly introduce into my practice. The Method of Ratios will allow the clinician to better understand what will be injected into a joint.
The appropriate method of advising an arthritic patient as to whether surgery may be postponed or even avoided begins with a specialty consultation including a comprehensive intake, a physical examination including functional testing, and review of images. Only those with specialty training, board certification and experience both in surgery and in regenerative medicine are able to properly advise the patient. I will again underscore the importance of choosing the Cellular Orthopedic expert and not determining what may be best for you by surfing the cloud.
If you want to become better informed, browse my website www.sheinkopmd.com.
You may watch my webinar at www.ilcellulartherapy.com or call to schedule a consultation (312) 475-1893.
Tags: Amniotic, amniotic fluid, arthritis, BMC Theraeutic Potential, bone marrow, cellular orthopedics, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Dr. David Karli, Greyledge, Interventional Orthopedics, Knee Pain Relief, OrthoBiologic Institute, Platelet Rich Plasma, Regenerative, stem cells
