Embryonic stem cell bank: a work proposal.

ABSTRACT

Human embryonic stem cells (hESCs) have an unlimited capacity to proliferate by a self-renewal process and can be differentiated in the three germ layers, opening doors to new clinical therapies to replace missing or damaged cells. The number of research groups and projects using human stem cells has increased largely in the last 5 yr. The creation of stem cell banks is another important step to support the advance of research in this field. Banks must be operated within the strict regulatory famework of good manufacturing practices and good laboratory practices that assure the highest quality standards and must implement a quality system that complies with international quality systems standards. It may also be appropriate to aim at an accreditation in order to assure correct laboratory practices at all times. Stem cell banks should receive the lines previously derived by other groups and hESCs should be provided for groups that justify their use in a research project previously approved by an ethical committee. The assays generally accepted as typical of hESCs together with the microbiological analysis should be performed in order to assure a consistent, reliable, and safe line for the researchers. In this article, the Andalusian Stem Cell Bank proposes a model of a stem cell banking process in order to create a flow diagram of hESC lines and, following the international initiatives in stem cells research, to achieve the full characterization of cells and a standardization of protocols that would simplify the hESCs culture.