“Why bother with the truth when you can make it all up”
“As practicing physicians, scientists, and regulatory experts we have increasingly observed aggressive advertising and sales tactics being used by alternative health clinics (chiropractors, naturopaths, and acupuncturists) as well as physicians and mid-level providers to market “stem cell” treatments derived from birth tissues. One example is full-page print ads in major newspapers used to recruit elderly patients and others desperate for effective treatments to seminars where prospective patients are informed that they can be injected with millions of live and functional stem cells to relieve their symptoms. The products used are derived from birth tissues such as umbilical cord blood and/or Wharton’s Jelly or amniotic fluid/membrane. Many patients spend thousands of dollars on these therapies to treat orthopedic problems and/or a myriad of other incurable diseases. The seminars typically state that there are robust clinical data supporting the safety and efficacy of these products, regardless of the condition or pathology being treated, when no such clinical evidence exists. In addition, some manufacturers of birth tissues claim that their products contain live and functional stem cells, while other manufacturers do not make these same claims. Claims of live cells are not compliant with FDA regulations, which require this type of donor tissue to be non-viable.
To date, two research investigations have been conducted which document the content of commercially available amniotic and cord blood products sold by FDA-registered manufacturers (those regulated solely under section 361 of the Public Health Service (PHS) Act). We are aware of additional investigations that are in progress. Both Berger, et al. and Becktell from the Fortier laboratory at Cornell University, found that these amniotic and cord blood products did not contain live or functional stem cells. In addition, both research groups found that many of the growth factor levels in these products were significantly lower than those found in common autologous orthobiologic products like platelet-rich plasma. Fortier et al. did report that these products do contain proteins like lumican and cytokines, which may positively impact orthopedic injuries, but concluded that more research is needed before any claims can be made. While there are early clinical data on stem cells that are isolated from fresh birth tissues and culture expanded, these studies used treatments which are not analogous to the commercially available, cryopreserved, FDA registered birth tissue products. In addition, it should be noted that while the clinical evidence in this area is evolving and one day may support the clinical efficacy of cryopreserved birth tissues for some orthopedic applications, no such evidence exists at this time. In particular, we are aware of FDA approved clinical trials that use these tissues for diseases such as knee osteoarthritis, which are ongoing.
Consensus Statement: The aggressive marketing approach currently used by practitioners and clinics regarding various birth tissue products as safe and effective “stem cell therapy” is not supported by the existing scientific literature.”
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, amniotic stem cells, Bone Marrow Concentrate, Clinical Studies, clinical trial, Clinical Trial. Mitchell B. Sheinkop, Cord blood, Cornell University, cryopreserved, FDA, Federal Trade Commission, Food and Drug Administration, FTC, joint pain, joint regeneration, joint replacement, Osteoarthritis, Public Health Service, Regenerative, research, stem cell, stem cell seminar, stem cell shot, surgery, umbilical cord blood, umbilical cord stem cells, Wharton’s Jelly
Why Should This Blog Matter To You?
- Stem cell treatments are NOT FDA cleared in the United States
- FDA is scrutinizing physicians and centers that are marketing stem cells
Beware of centers that are offering to:
- Relieve pain
- “Regeneration” of tissues
- Avoid surgery
- Treating a variety of inflammatory, degenerative, or autoimmune conditions
Beware of Stem Cells Clinics!
- Many of these “stem cell clinics” are operated by chiropractors or providers that do NOT have a specialty or advanced training in the musculoskeletal system.
- They simply do not have the training necessary to perform these injections nor are they licensed to so do.
- In some cases, surgery is needed. These providers may not evaluate the need for a surgical procedure.
Federal Trade Commission Press Release: https://www.ftc.gov/news-events/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic
FTC Court Documents: https://www.ftc.gov/enforcement/cases-proceedings/172-3062/regenerative-medical-group-inc
The Complaint filed by the FTC on October 12th states the following:
Defendant Henderson is aware that the vast majority of amniotic clinical studies in the scientific literature has been conducted on animal models. There are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases of health conditions in humans, and the medical community considers amniotic stem cell therapy to be an experimental and unproven treatment. (p. 4)
The representations set forth in Paragraph 21 […Defendants have represented…that their stem cell therapy: cures [everything]…Is comparable to or superior to conventional medical treatments in curing, mitigating, or treating specific diseases or health conditions including [everything]…] are false or were not substantiated at the time the representations were made. (p. 21)
The FTC essentially has said that there is no clinical basis to claim a therapeutic benefit to treating patients with amniotic stem cells, so the claims and representations by Dr. Henderson constitute deceptive practices and false advertisement.
If you connect the dots, it would suggest that Dr. Henderson engaged in fraud by taking money from patients and treating them with a preparation for which there is no clinically valid proof of therapeutic benefit. Regardless of whether the Department of Justice gets after him for a criminal complaint of fraud or not, I think organizations that offer up a worthless therapy consisting of amniotic stem cells (until proven otherwise with Level 1 studies) could be good targets for class action lawsuits by defrauded patients. The same situation doesn’t apply to PRP and BMC, (what I do) since there is plenty of clinical evidence of therapeutic benefit including my scientific article published in December, 2018.
Sheinkop, et.al Transnational Medicine – published Dec. 13 2018
A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis; a randomized control trial with 2 year follow-up.
If you want to complain to the FDA about having received Amniotic Fluid without benefit, use this link:
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, amniotic stem cells, Bone Marrow Concentrate, Clinical Studies, clinical trial, Clinical Trial. Mitchell B. Sheinkop, Cord blood, FDA, joint pain, joint regeneration, joint replacement, Osteoarthritis, Regenerative, research, stem cell, surgery
You may recall from my last several Blogs that The American Journal of Orthopedics published my paper in November: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis. While surfing the internet this morning, I noted that many physicians are labeling the procedure a source of stem cells; it is not.
Lipogems is now U.S. Food and Drug Administration (FDA) approved for use in Orthopedics. The proprietary name is applied to a Micro-fragmented Adipose Tissue Transplant System that was the technology I introduced and monitored in a scientific clinical trial dating back three years leading to the publication. Federal regulators have now cleared the way for the device and technology that uses a patient’s own body fat (known clinically as adipose tissue) to assist in the healing process. Lipogems is attractive to orthopedic physicians because it is compliant with the latest FDA guidelines and is cleared for use in orthopedics. Unfortunately, clinics and physicians are erroneously, describing the procedure as a source of stem cells; I will emphasize again it is not. Even the Lipogems company uses term reparative and not regenerative.
The Power of Fat
When I grew up, my grandmother and mother fed me chicken soup for whatever ailed me. Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. Micro fragmented adipose tissue may be an option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.
In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products. The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use. “Fat has been used for many years in support of the repair or replacement of damaged or injured tissue,” according to Dr. Arnold Caplan of Case Western Reserve University in Cleveland, Ohio. “Fat has a high concentration of reparative cells and is a very powerful tissue. How the fat is processed makes a huge difference on the quality of the tissue and if it meets the new FDA guidelines.”
To schedule an evidence-based consultation for your arthritic joint, call (312) 475-1893.
You may access my website at www.sheinkopmd.com
If you schedule before the end of the year, I will share my wife’s chicken soup recipe on request
Tags: arthritis, athletes, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, knee pain, lipogems, Micro-fragmented Adipose Tissue Transplant, Osteoarthritis, stem cells
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.
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
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:
Physicians who use compliant regenerative therapies:
- Amniotic fluid without stem cells
- Blood-derived preparations (e.g., PRP, PPP)
- Bone marrow aspirate
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