Category UNPROVEN THERAPIES

Harms Linked to Unapproved Stem Cell Interventions Highlight Need for Greater FDA Enforcement

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,

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Study reveals tactics used by US stem cell clinics to market their treatments

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

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The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Ethical issues and misinformation linked to overhyped science.

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

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Internet hawkers of stem cell therapies for ocular diseases

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

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Unapproved Stem Cell Therapies Harms Highlight Need for Greater Regulatory Enforcement

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

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Bioethicist condemn unproven and unlicensed ‘stem cell treatments’ for COVID-19

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

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Raised alarm on unproven stem cells marketing as COVID therapy

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

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EMA warns against using unproven cell-based therapies

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based therapies which may not be safe or effective. The CAT’s advice is in response to individuals, companies and hospitals promoting unproven cell-based therapies as cures for a broad range of conditions including cancer, cardiovascular diseases, autism,cerebral palsy, muscular

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ISSCR Statement Regarding the Marketing of Unproven Stem Cell Treatments for COVID-19

ISSCR has become aware of recent claims that stem cells can be used to treat people infected with COVID-19. While stem cell research shows promise for numerous diseases and conditions, there currently are no approved stem cell-based approaches for the prevention and treatment of COVID-19 infection. The ISSCR is a vocal and active opponent of the premature

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