Standard Operating Procedure (SOP) for Generating Clinical Grade Human Induced Pluripotent Stem Cells (hiPSC) under Good Manufacturing Practice (GMP) to Treat Human Disease

Dear Colleagues,

It has been just over ten years since the discovery of generating human iPSC  from patient cells by Dr. S. Yamanaka, and, in that short time, it has moved from bench to bedside. The RIKEN project is the first clinical trial to use patient iPSC derived cells to treat a human disease, namely wet AMD. More clinical grade studies will follow calling for a global standardization of the protocols to generate clinical grade human iPSC and derived cells. The question is: What constitutes a clinical grade human iPSC and derived cells for transplantation in humans? What are the legal and ethical issues surrounding this new and exciting field in regenerative medicine to treat human disease? This Special Issue in the Journal of Clinical Medicine explores these questions with invited experts in the field. Your manuscript can be a comment on a published paper or published guideline, a personal opinion related to the Special Issue topics listed, a review of the current literature or include data as a research paper related to the topics listed.

Topics can include:

1. Description and comments of SOP
2. Infrastructure and logistics of cell production
3. Legal and ethical issues
4. What constitutes "Clinical grade for iPSC"
5. HLA cell banking and crisper/Cas9
6. Methodology to make human iPSC (virus vs. non viral methods - is that important?)
7. Differentiation protocols to cells for transplantation
8. Commercialization and biotechnology industry including companies that currently offer hiPSC
9. Current clinical trials in progress with hiPSC to treat human disease

Dr. Michael J. Edel
Guest Editor

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