Unproven regenerative medical products have led to infections, disabilities, and deaths Stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases. Although some have earned approval from the Food and Drug Administration, most have not, and many of these unapproved interventions have led to life-threatening infections, chronic pain,
Stem cell clinics continue to thrive in the US and worldwide, building their business on misleading advertising and offering unapproved and unproven stem-cell-based interventions (SCBI). A research recently published in Stem Cell Reports by Emma Frow, David Brafman, and colleagues from Arizona State University, asked what kinds of claims and evidence these clinics use to market their
In March 2021, 1,480 U.S. businesses operating 2,754 clinics were found selling purported stem cell treatments for various indications. More than four times as many businesses than were identified 5 years ago are selling stem cell products that are not FDA-approved and lack convincing evidence of safety and efficacy following a new paper published in Cell
A guide to to determine if something is pseudoscience or real science Click the link Your first exposure to any pseudoscientific claim will almost certainly come in the form of a catchy headline—perhaps a little too catchy. John Gregory, a researcher for the online fact-checking service NewsGuard, warns that fully capitalized words, exclamation points, or strong
Patients have been blinded or have experienced retinal detachments after treatment with so-called stem cell therapies such as intravitreal injections of autologous stem cells that are not FDA approved for many ocular conditions across the US and that were marketed directly to patients. Currently, the FDA has regulatory authority over such companies and since June
Unproven regenerative medical products have led to infections, disabilities and deaths Overview Stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases. Although some have earned approval from the Food and Drug Administration, most have not, and many of these unapproved interventions have led to life-threatening infections, chronic
Women and children bear substantial morbidity and mortality as a result of armed conflicts. This paper published in The Lancet focuses on the direct (due to violence) and indirect health effects of armed conflict on women and children (including adolescents) worldwide. It was estimate that nearly 36 million children and 16 million women were displaced
A new paper published on JAMA by Peter W. Marks and Stephen Hahn of FDA The products administered by clinics under the broad rubric of regenerative medicine include those derived from individuals’ own bone marrow or fat, those derived from birthing tissues such as placenta or cord blood obtained from a donor unrelated to the
As the COVID-19 pandemic enters its third month, businesses in the United States are marketing unlicensed and unproven stem-cell-based “therapies” and exosome products that claim to prevent or treat the disease. In Cell Stem Cell on May 5, bioethicist Leigh Turner describes how these companies are “seizing the pandemic as an opportunity to profit from hope and
Scientists and international bodies including Stem Cells Australia, the International Society for Stem Cell Research, the International Society for Cell and Gene Therapy and EuroStemCell have raised the alarm about the marketing of unproven therapies during the pandemic, warning of damage to patients and to the credibility of the field. Source The Medical Republic Professor Daniel
