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Stem-cell therapy is the use of stem cells to treat or prevent diseases or medical conditions. As of 2024, the only stem-cell therapy approved by the U.S. FDA is hematopoietic stem cell transplantation (HSCT), typically using bone marrow or peripheral blood stem cells, and sometimes umbilical cord blood. Historically, HSCT has been used for decades—especially for blood cancers such as leukemia and lymphoma—and works by replacing damaged or destroyed hematopoietic stem cells after chemotherapy while also contributing to an immune response against cancer. Beyond established HSCT, research is exploring additional stem-cell sources and approaches for emerging or promising indications, including neurodegenerative diseases (e.g., Parkinson’s disease and others), diabetes, heart disease, tissue repair, and immune-related conditions. Stem cells are commonly isolated from a patient’s bone marrow or adipose tissue for regenerative purposes, and their effects are often explained through both direct differentiation into target tissues and indirect mechanisms such as anti-inflammatory signaling, recruitment of other cells, modulation of immune responses, and support of tissue remodeling. The field also includes work on stem-cell expansion (growing large numbers of high-quality cells in 2D or 3D culture) and on generating or sourcing stem cells from embryonic lines, umbilical cord/extra-embryonic tissues, and induced pluripotent stem cells. The scope of stem-cell therapy is broad but controversial. It has drawn debate due to techniques used to derive embryonic stem cell lines and related ethical concerns, as well as because some marketed “stem cell” treatments have been offered without strong evidence or regulatory approval. Regulatory agencies have issued warnings and taken action against misleading marketing, particularly in contexts such as unproven COVID-19-related stem-cell and exosome products.
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