Special Announcement - Now Enrolling for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for the first of its kind FDA approved stem cell clinical trial for knee arthritis. Our clinic is now enrolling patients in this trial. Contact us at 312-475-1893 for details. Click here to learn more.
Dr. Mitchell Sheinkop Co-Authors Article Published in the International Journal of Recent Scientific Research

Dr. Mitchell Sheinkop Co-Authors Article Published in the International Journal of Recent Scientific Research

This excerpt is taken from the full article, which can be read here. Copyright © Mitchell B Sheinkop and Maxwell Dordevic,2019,

Abstract

This case report will introduce the concept of using an acellular mesenchymal stem cell (MSC) derived extracellular vesicle isolate product (EVIP) containing active growth factors (GFs) and exosomes to treat hip osteoarthritis (OA) as well as the rationale of why acellular may replace all current cellular biologic therapies both autogenous and allogeneic presently in use.

Excerpt

INTRODUCTION Hip osteoarthritis (OA) has demonstrated, in both cadaver and radiographic studies, to affect up to 55 million patients over the age of 60.1 Patients with hip OA have pain, crepitus, loss of motion, and decreased ability to weight bear or ambulate. Limiting the ability to ambulate severely impairs activities of daily living. The nonsurgical treatments for hip OA according to the American Academy of Orthopedic Surgeons (AAOS),include weight loss, gentle exercise, and the use of non-steroidal anti-inflammatory medications. The surgical treatment for hip OA is total hip arthroplasty (THA).2 The AAOS does not recommend hip arthroscopy or the use of any Hyaluronic Acid injections. Over the last few years, it has become increasingly understood by researchers and clinicians that the clinical efficacy of utilizing mesenchymal stem cells (MSCs) to treat osteoarthritis (OA) is not dependent on the cells differentiating into articular cartilage but entirely on their paracrine release of growth factors (GFs) and exosomes. Living MSCs are not required to accomplish the release of GFs and exosomes into an arthritic joint. This case report will introduce the concept of using an acellular MSC derived extracellular vesicle isolate product(EVIP) containing active growth factors and exosomes to treat hipOAas well as the rationale of why acellular may replace all current cellular biologic therapies both autogenous and allogeneic presently in use.

MATERIALS AND METHODS This is a case report of an EVIP injection for the treatment of hip osteoarthritis. OA is defined by swelling, pain, and stiffness in the hipjoint. Symptoms are typically worsened by weight bearing and ambulation.Radiographs and MRI scanning wereused tograde osteoarthritis of the hip joint from one to four using the Kellgen-Lawrence scale.12 The patient is a 63-year-old retired Chicago Fireman. He presented with increasing pain in the left groin and a progressive loss of ability to continue his daily health club fitness routine. He experienced a progressive loss of hip mobility.MRI scanning and radiographs of the left hip joint were compatible with Kellgren-Lawrence Grade 3 osteoarthritic changes of the left hip joint. On physical examination, he had an antalgic limp and a positive Trendelenburg sign. Passive ROM of the hip joint was associated with the reproduction of severe groin pain, crepitus, and a loss of internal rotation. The patient had a BMI of 27. NSAIDs had failed to provide adequate pain relief. The patient was seriously considering total hip arthroplasty. In an attempt to avoid surgery, he elected to have an injection of an EVIP containing active GFs and exosomes into his hip.

Read the full article at here.

Mitchell B Sheinkop and Maxwell Dordevic.2019, Intra-Articular Injection of An Extracellular Vesicle Isolate Product to Treat Hip Osteoarthritis. Int J Recent Sci Res. 10(12), pp. 36230-36232. DOI: http://dx.doi.org/10.24327/ijrsr.2019.1012.4884

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“Why bother with the truth when you can make it all up”
David Baldacci

“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.”

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Fake news and illegal advertising of stem cell therapies

Fake news and illegal advertising of stem cell therapies

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:

https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/ucm118859.htm

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