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]

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Summary

Operational Standards and Bank Organization

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.

Summary
A New Cell Bank: iPSC Bank Is a New Legal and Administrative Entity
Repurposing the Samples
Information Brochure for the Donor and Informed Consent
Signing Procedures Are Valid and Legally Binding
Friendly Information for Donor Autonomy During IC
Harmonizing IC Internationally
Health Questionnaires and Medical Records
Specimen Collection and Donor Eligibility
Genotyping for HLA
Notification of Relevant Clinical Data and Counselling
Cell Reprogramming to iPSC
Cell Characterization Pipeline
Quality Control and Safety
Data Collection and Confidentiality
Sample Release
International Harmonization of HLA-Homozygous iPSC Procurement and Production
Findings
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