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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"

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Cell Biology".

Deadline for manuscript submissions: 25 June 2019

Special Issue Editor

Guest Editor
Dr. Michael J. Edel

Principle Scientist, Department of Biomedicine, Institute of Neuroscience, University of Barcelona, Spain
Website | E-Mail
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

Special Issue Information

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

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.

Keywords

  • Human induced pluripotent stem cells (hiPSC)
  • Standard operating procedure (SOP)
  • Good manufacturing practice (GMP)
  • Human disease
  • HLA cell bank
  • Clinical grade
  • Ethics

Published Papers (3 papers)

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Research

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Open AccessArticle
Human iPSC-Chimera Xenotransplantation and the Non-Identity Problem
J. Clin. Med. 2019, 8(1), 95; https://doi.org/10.3390/jcm8010095
Received: 12 December 2018 / Revised: 1 January 2019 / Accepted: 3 January 2019 / Published: 15 January 2019
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Abstract
Xenotransplantation is often deemed morally objectionable because of the costs it imposes on the organ donor and the risks it imposes on the recipient. For some, involving human–pig chimeras as donors makes the practice more objectionable or even abhorrent from the start. For [...] Read more.
Xenotransplantation is often deemed morally objectionable because of the costs it imposes on the organ donor and the risks it imposes on the recipient. For some, involving human–pig chimeras as donors makes the practice more objectionable or even abhorrent from the start. For others, by contrast, using such chimeras weakens recipient-based objections because it reduces the risk of organ rejection and malfunctioning, and cancels donor-based objections because the practice does not harm chimeras but instead gives them valuable lives they would not otherwise have. The paper examines and eventually rejects the latter defense. It also discusses the additional risks of chimeric xenotourism in countries with less demanding procedural guidelines and reflects on two very different futures for humanity that may emerge from supporting or rejecting chimeric xenotransplantation. Full article

Review

Jump to: Research

Open AccessReview
Adapting Cord Blood Collection and Banking Standard Operating Procedures for HLA-Homozygous Induced Pluripotent Stem Cells Production and Banking for Clinical Application
J. Clin. Med. 2019, 8(4), 476; https://doi.org/10.3390/jcm8040476
Received: 18 February 2019 / Revised: 31 March 2019 / Accepted: 3 April 2019 / Published: 8 April 2019
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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, [...] Read more.
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. Full article
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Open AccessReview
iPS-Cell Technology and the Problem of Genetic Instability—Can It Ever Be Safe for Clinical Use?
J. Clin. Med. 2019, 8(3), 288; https://doi.org/10.3390/jcm8030288
Received: 14 February 2019 / Revised: 23 February 2019 / Accepted: 25 February 2019 / Published: 28 February 2019
Cited by 1 | PDF Full-text (1552 KB) | HTML Full-text | XML Full-text
Abstract
The use of induced Pluripotent Stem Cells (iPSC) as a source of autologous tissues shows great promise in regenerative medicine. Nevertheless, several major challenges remain to be addressed before iPSC-derived cells can be used in therapy, and experience of their clinical use is [...] Read more.
The use of induced Pluripotent Stem Cells (iPSC) as a source of autologous tissues shows great promise in regenerative medicine. Nevertheless, several major challenges remain to be addressed before iPSC-derived cells can be used in therapy, and experience of their clinical use is extremely limited. In this review, the factors affecting the safe translation of iPSC to the clinic are considered, together with an account of efforts being made to overcome these issues. The review draws upon experiences with pluripotent stem-cell therapeutics, including clinical trials involving human embryonic stem cells and the widely transplanted mesenchymal stem cells. The discussion covers concerns relating to: (i) the reprogramming process; (ii) the detection and removal of incompletely differentiated and pluripotent cells from the resulting medicinal products; and (iii) genomic and epigenetic changes, and the evolutionary and selective processes occurring during culture expansion, associated with production of iPSC-therapeutics. In addition, (iv) methods for the practical culture-at-scale and standardization required for routine clinical use are considered. Finally, (v) the potential of iPSC in the treatment of human disease is evaluated in the light of what is known about the reprogramming process, the behavior of cells in culture, and the performance of iPSC in pre-clinical studies. Full article
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Planned Papers

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

J. Clin. Med. EISSN 2077-0383 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
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