![]() ![]() Safety Concerns for Unproven Stem Cell TreatmentsĪll medical treatments have benefits and risks. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use. ![]() These FDA-approved stem cell products are listed on the FDA website. These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the “hematopoietic” system). 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.
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