Cells are the building blocks of all living organisms, and inside each cell are genes. Genes are tiny segments of DNA that contain genetic information and instructions that are crucial for building and maintaining the body.
Cell therapy involves removing cells from a person, modifying or editing these cells, then transferring the live, modified/edited cells into a patient to treat or cure a disease. These cells can come from the patient themselves (autologous cells) or from a donor (allogenic cells).
Gene therapy uses genetic material to treat or prevent disease by introducing new genetic material directly into the patient’s cells. Gene therapy can alter how cell functions, ultimately helping combat diseases.
These therapies are regulated through FDA’s CBER.
