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Standard Operating Procedure (SOP) for Generating Clinical Grade Human Induced...
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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 "Immunology".

Deadline for manuscript submissions: closed (30 September 2019) | Viewed by 23964

Special Issue Editor

Dr. Michael J. Edel

E-Mail Website
Guest Editor
Department of Biomedicine, Institute of Neuroscience, University of Barcelona, Barcelona, Spain
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 Issues, Collections and Topics in MDPI journals

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 submissions that pass pre-check are 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 semimonthly 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 2600 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 (4 papers)

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Research

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24 pages, 6722 KiB  
Article
3,2′-Dihydroxyflavone Improves the Proliferation and Survival of Human Pluripotent Stem Cells and Their Differentiation into Hematopoietic Progenitor Cells
by Kyeongseok Kim, Ahmed Abdal Dayem, Minchan Gil, Gwang-Mo Yang, Soo Bin Lee, Oh-Hyung Kwon, Sangbaek Choi, Geun-Ho Kang, Kyung Min Lim, Dongho Kim and Ssang-Goo Cho
J. Clin. Med. 2020, 9(3), 669; https://doi.org/10.3390/jcm9030669 - 02 Mar 2020
Cited by 10 | Viewed by 3359
Abstract
Efficient maintenance of the undifferentiated status of human pluripotent stem cells (hiPSCs) is crucial for producing cells with improved proliferation, survival and differentiation, which can be successfully used for stem cell research and therapy. Here, we generated iPSCs from healthy donor peripheral blood [...] Read more.
Efficient maintenance of the undifferentiated status of human pluripotent stem cells (hiPSCs) is crucial for producing cells with improved proliferation, survival and differentiation, which can be successfully used for stem cell research and therapy. Here, we generated iPSCs from healthy donor peripheral blood mononuclear cells (PBMCs) and analyzed the proliferation and differentiation capacities of the generated iPSCs using single cell NGS-based 24-chromosome aneuploidy screening and RNA sequencing. In addition, we screened various natural compounds for molecules that could enhance the proliferation and differentiation potential of hiPSCs. Among the tested compounds, 3,2′-dihydroxyflavone (3,2′-DHF) significantly increased cell proliferation and expression of naïve stemness markers and decreased the dissociation-induced apoptosis of hiPSCs. Of note, 3,2′-DHF-treated hiPSCs showed upregulation of intracellular glutathione (GSH) and an increase in the percentage of GSH-high cells in an analysis with a FreSHtracer system. Interestingly, culture of the 3,2′-DHF-treated hiPSCs in differentiation media enhanced their mesodermal differentiation and differentiation into CD34+ CD45+ hematopoietic progenitor cells (HPC) and natural killer cells (NK) cells. Taken together, our results demonstrate that the natural compound 3,2′-DHF can improve the proliferation and differentiation capacities of hiPSCs and increase the efficiency of HPC and NK cell production from hiPSCs. Full article
(This article belongs to the 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)
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13 pages, 238 KiB  
Article
Human iPSC-Chimera Xenotransplantation and the Non-Identity Problem
by Paula Casal and Andrew Williams
J. Clin. Med. 2019, 8(1), 95; https://doi.org/10.3390/jcm8010095 - 15 Jan 2019
Cited by 4 | Viewed by 3469
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
(This article belongs to the 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)

Review

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15 pages, 1167 KiB  
Review
Adapting Cord Blood Collection and Banking Standard Operating Procedures for HLA-Homozygous Induced Pluripotent Stem Cells Production and Banking for Clinical Application
by Belén Alvarez-Palomo, Joaquim Vives, Ricardo P. Casaroli-Marano, Susana G. Gomez, Luciano Rodriguez Gómez, Michael J. Edel and Sergi Querol Giner
J. Clin. Med. 2019, 8(4), 476; https://doi.org/10.3390/jcm8040476 - 08 Apr 2019
Cited by 19 | Viewed by 4810
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
(This article belongs to the 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)
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28 pages, 1552 KiB  
Review
iPS-Cell Technology and the Problem of Genetic Instability—Can It Ever Be Safe for Clinical Use?
by Stephen W. Attwood and Michael J. Edel
J. Clin. Med. 2019, 8(3), 288; https://doi.org/10.3390/jcm8030288 - 28 Feb 2019
Cited by 54 | Viewed by 10541
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
(This article belongs to the 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)
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