The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. So be cautious about these treatments.Ībout FDA-approved Products Derived from Stem Cells But when clinical trials are not conducted under an IND, it means that the FDA has not reviewed the experimental therapy to help make sure it is reasonably safe. Some clinics also may falsely advertise that FDA review and approval of the stem cell therapy is unnecessary. That said, some clinics may inappropriately advertise stem cell clinical trials without submitting an IND. (You can learn more about clinical trials on the FDA’s website.) The FDA also requires sufficient data from animal studies to help evaluate any potential risks associated with product use. The FDA has reviewed many stem cell products for use in these studies.Īs part of the FDA’s review, investigators must show how each product will be manufactured so the FDA can make sure appropriate steps are being taken to help assure the product’s safety, purity, and strength (potency). With limited exceptions, investigational products must also go through a thorough FDA review process as investigators prepare to determine the safety and effectiveness of products in well-controlled human studies, called clinical trials. Today, doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system.Įlectron micrograph of stem cells, color-enhanced for visual clarity. The FDA has the authority to regulate stem cell products in the United States. Being studied under an Investigational New Drug Application (IND), which is a clinical investigation plan submitted and allowed to proceed by the FDA.Īnd see the boxed section below for more advice.To do your part to stay safe, make sure that any stem cell treatment you are considering is either: And the FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics, while continuing to encourage innovation so that the medical industry can properly harness the potential of stem cell products. Food and Drug Administration is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. They have the potential to repair, restore, replace, and regenerate cells, and could possibly be used to treat many medical conditions and diseases.īut the U.S. Sometimes called the body’s “master cells,” stem cells are the cells that develop into blood, brain, bones, and all of the body’s organs. The facts: Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist. So beware of potentially dangerous procedures-and confirm what’s really being offered before you consider any treatment. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. Stem cells have been called everything from cure-alls to miracle treatments. But unproven stem cell treatments can be unsafe-so get all of the facts if you’re considering any treatment. Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases.
0 kommentar(er)
