Recently, various innovative therapies involving the introduction of somatic cells into humans have been used or proposed. germ line gene therapy and somatic gene therapy. As scientific knowledge in the area of somatic cell and gene therapy continues to accumulate and evolve, the agency's approach may also evolve. how a particular somatic cell therapy or gene therapy product is regulated. Somatic gene therapy involves the introduction of novel genetic material into somatic cells to express therapeutic gene products. This review summarizes the principles of gene therapy … be used in somatic cell therapy or gene therapy. This process is used to remove and replace unwanted genes such as genes that indicate … The difference between these two approaches is that in somatic gene therapy genetic material is inserted in some target cells, but the change is not passed along to the next generation, whereas in germ line gene therapy the therapeutic or modiﬁed gene … This emerging technology holds great promise for the treatment of both inherited and acquired diseases. a. Somatic Genetic Modification is the process of adding, cutting, or changing the genes in cells in an individual. PDF | Conducting a clinical trial poses a unique set of challenges that must be addressed to ensure the safety of human subjects.