Abstract
In this article, we will discuss the main aspects to be considered to define standard operation procedures (SOPs) for the creation of an induced pluripotent stem cell (iPSC) bank using cord blood (CB)—or similar cell type—bank guidelines for clinical aims. To do this, we adapt the pre-existing SOP for CB banking that can be complementary for iPSCs. Some aspects of iPSC manufacturing and the particular nature of these cells call for special attention, such as the potential multiple applications of the cells, proper explanation to the donor for consent of use, the genomic stability and the risk of genetic privacy disclosure. Some aspects of the iPSC SOP are solidly established by CB banking procedures, other procedures have good consensus in the scientific and medical community, while others still need to be further debated and settled. Given the international sharing vocation of iPSC banking, there is an urgent need by scientists, clinicians and regulators internationally to harmonize standards and allow future sample interchange between many iPSC bank initiatives that are springing up worldwide.
Highlights
The International Stem Cell Banking Initiative (ISCBI) published an extensive article on the development of induced pluripotent stem cell (iPSC) banJk
Adaption of cord blood (CB) SOPs to create international SOPs for iPSC clinical use has been proposed in this review
An HLA haplotype iPSC bank is conceived for an allogeneic use and the general opinion is that donors are not to be compensated or personally benefit from the donation [22]
Summary
From contacting donors to releasing a clinical-grade iPSC to an external partner for clinical use, a long list of steps have to be followed and each step involves a considerable number of documents to be created in the form of manuals, SOPs, records, lists and others that will assure the good management, functionality, traceability and accounting of the bank.
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