Special Issue "Standard Operating Procedure (SOP) for Generating Clinical Grade Human Induced Pluripotent Stem Cells (hiPSC) under Good Manufacturing Practice (GMP) to Treat Human Disease"
Deadline for manuscript submissions: 25 June 2019
Dr. Michael J. Edel
Principle Scientist, Department of Biomedicine, Institute of Neuroscience, University of Barcelona, Spain
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Interests: induced pluripotency stem cells (iPSC); neural stem cells; cardiac stem cells; direct cell reprogramming with synthetic mRNA; embryological development; cell cycle; cancer biology; 3D organ bioengineering; clinical grade cell replacement therapy
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:
- Description and comments of SOP
- Infrastructure and logistics of cell production
- Legal and ethical issues
- What constitutes "Clinical grade for iPSC"
- HLA cell banking and crisper/Cas9
- Methodology to make human iPSC (virus vs. non viral methods - is that important?)
- Differentiation protocols to cells for transplantation
- Commercialization and biotechnology industry including companies that currently offer hiPSC
- Current clinical trials in progress with hiPSC to treat human disease
Dr. Michael J. Edel
Manuscript Submission Information
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All papers will be peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Clinical Medicine is an international peer-reviewed open access monthly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1800 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
- Human induced pluripotent stem cells (hiPSC)
- Standard operating procedure (SOP)
- Good manufacturing practice (GMP)
- Human disease
- HLA cell bank
- Clinical grade
The below list represents only planned manuscripts. Some of these manuscripts have not been received by the Editorial Office yet. Papers submitted to MDPI journals are subject to peer-review.
Title 1: iPS cell technology and the problem of genetic instability―can it ever be safe for clinical use?
Authors: Stephen W. Attwood and Michael J. Edel
Title 2: Adapting Cord Blood collection and banking Standard Operating Procedures for HLA-homozygous induced Pluripotent Stem Cells production and banking for clinical application
Authors: Belén Alvarez-Palomo, Joaquim Vives Armengol, Ricardo P. Casaroli-Marano, Susana G. Gomez, Michael J. Edel and Sergi Querol Giner
Title 3: Standard Operating Procedure for assessment of Genetic Instability for clinical grade human iPSC
Author: Jo Mountford