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2. Potential Risks of Treatment with Unapproved Regenerative...

   www.fda.gov/news-events/fda-voices/potential-risks-treatment-unapproved...

   FDA is providing additional resources to help consumers understand the risks associated with unapproved stem cell, exosome, and other products marketed as regenerative medicine products.

3. Innovative Regenerative Medicine Therapies – Safety Comes First

   www.fda.gov/news-events/fda-voices/innovative-regenerative-medicine-therapies...

   The US Stem Cell decision is a victory for public health and an endorsement of the FDA’s work to stop stem cell clinics that place patients at risk by marketing products that violate the law.

4. FDA sends warning to company for marketing dangerous unapproved...

   www.fda.gov/news-events/press-announcements/fda-sends-warning-company...

   The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant ...

5. Important Patient and Consumer Information About Regenerative...

   www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and...

   These unapproved products whether recovered from your own body or another person’s body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood ...

6. Consumer Alert on Regenerative Medicine Products Including Stem...

   www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert...

   Healthcare professionals and consumers should report any adverse events related to the use of stem cells, exosomes, or other products purported to be regenerative medicine products to the FDA’s ...

7. FDA seeks permanent injunctions against two stem cell clinics

   www.fda.gov/.../fda-seeks-permanent-injunctions-against-two-stem-cell-clinics

   In August 2017, the FDA took action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California and administered to patients at the ...

8. Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s...

   www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott...

   FDA warns US Stem Cell Clinic of significant deviations; FDA acts to remove unproven, potentially harmful treatment used in a stem cellâ centers targeting vulnerable patients

9. FDA Approves Cell Therapy for Patients with Blood Cancers to...

   www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients...

   Stem cell transplantation is a common treatment for blood cancers. It involves putting healthy stem cells into the body to help restore the normal production and function of blood cells.

10. FDA Warns About Stem Cell Therapies | FDA - U.S. Food and Drug...

    www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies?elq...

    But unproven stem cell treatments can be unsafe—so get all of the facts if you’re considering any treatment. Stem cells have been called everything from cure-alls to miracle treatments.

11. FDA acts to remove unproven, potentially harmful treatment used...

    www.fda.gov/news-events/press-announcements/fda-acts-remove-unproven...

    The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and ...