Induced pluripotent stem cells (iPS cells) are differentiated cells that are reprogrammed back into an embryonic-like state. Derived from skin or blood cells, iPS cells are not controversial, because they are made from adult cells. As pluripotent stem cells, they can give rise to nearly all of the tissues that form the human body.
In this article:
- Discovery of iPS Cells
- iPS Cells versus Embryonic Stem Cells
- Diseases Treatable with iPS Cells
- iPS Cell Market Funding
- iPS Cell Market Growth
- iPS Cell Clinical Trials
- iPS Cell Companies
- Learn About iPS Cells
iPS Cells | Everything You Need to Know
Discovery of iPS Cells
Pluripotent stem cells can replicate and help to repair damaged tissues within the body. In 2006, the Japanese scientist Shinya Yamanaka used the concept of pluripotent stem cells to demonstrate that an ordinary cell can be turned into a pluripotent cell by genetic modification.
He called these genetically reprogrammed cells induced pluripotent cells, often abbreviated as iPS cells.
Human Pluripotent Stem Cells for Therapy
.@NobelPrize winner Shinya Yamanaka talking at #ISSCR2017 about his research on how HLA homozygous donors can help scale up iPSC therapy pic.twitter.com/gVhcUDdjhz
— 🔬Samantha Yammine 🏳️🌈 (@SamanthaZY) June 14, 2017
iPS cells have significant potential for therapeutic applications. For autologous applications, the cells are extracted from the patient’s own body, making them genetically identical to the patient and eliminating the issues associated with tissue matching and tissue rejection.
iPS Cells versus Embryonic Stem Cells
Derived from skin or blood cells, iPS cells are not controversial. Unlike embryonic stem cells, iPS cells are made from adult cells instead of embryos. iPS cells are mature, differentiated cells that get manipulated by researchers within a laboratory to reverse to an embryonic-like state.
Human Embryonic Stem Cells
In contrast, human embryonic stem cells (ESCs) are controversial. This is because embryonic stem cells are derived from embryos created at fertility clinics with informed donor consent. ESCs are harvested shortly after fertilization, usually within 4-5 days. They are created from the inner cell mass of the blastocyst.
Scientists first isolated embryonic stem cells in mice in 1981. Seventeen years later, in 1998, researchers isolated human embryonic stem cells. Ethical concerns caused much of that gap in research.
Human iPS Cells
In contrast, iPS cells were discovered in mice in 2006 and then in humans by 2007. iPS cells are non-controversial, which allowed quicker and more intensive experimentation with human cells. Additionally, advances with embryonic stem cells helped to support research progress with iPS cells, because iPS cells and embryonic stem cells share traits associated with pluripotency.
As pluripotent stem cells, both embryonic stem cells and iPS cells can become any of the approximately 200 cell types that form the human body.
Diseases Treatable with iPS Cells
iPS cells have the potential to treat a wide range of diseases, including:
- diabetes
- heart diseases
- autoimmune diseases
- neural complications such as Parkinson’s disease, and Alzheimer’s disease
Importantly, iPS cells are already being widely implemented for use in drug development and discovery, as well as toxicology screening.
Further Research on iPS Cell Technology
iPS Cell Applications – iPS cells have the potential to be used to treat a wide range of diseases, including #diabetes, #heartdisease, autoimmune diseases, and neural complications, such as Parkinson’s and Alzheimer’s disease. https://t.co/lSeVLyPaj4 pic.twitter.com/moTkN1y7Li
— BioInformant (@StemCellMarket) June 24, 2018
Having realized the numerous benefits offered by iPSC technology, research involving iPSCs has been underway in leading nations worldwide. For example, provisions of grants from the National Institutes of Health (NIH) and National Ataxia Foundation (NAF) have been encouraging research institutes to venture into iPSC research.
The NIH invested an estimated $1.495 billion into stem cell research projects in 2016, spanning a wide range of fields from cell biology to electrical engineering.
iPS Cell Market Funding
Several U.S. state programs have also made contributions to stem cell research projects, led by the California Institute of Regenerative Medicine (CIRM) that approved a plan to spend $3 billion to support stem cell research.
On the academic front, the Washington University School of Medicine in St. Louis received a $10 million commitment from the Couch family in November 2017 to support research that advances personalized medicine, including support for the university’s Genome Engineering and Induced Pluripotent Stem Cell Center.
In April 2016, the NAF had also awarded four post-doctoral fellowship grants covering various aspects of ataxia research, including one for exploration of advanced models based on induced pluripotent stem cells (iPSCs) of Machado-Joseph disease (MJD).
Japan’s Education Ministry
Despite support for stem cell research at large within the U.S., Japanese support has been even more favorable toward iPS cells. Japan’s Education Ministry announced that it planned to spend 110 billion yen ($1.13 billion) on induced pluripotent stem cell research during the next 10 years, and the Japanese parliament has been discussing bills that would “speed the approval process and ensure the safety of such treatments.”
The Japanese parliament also passed a law calling for Japan to make regenerative medical treatments like iPSC technology available for its citizens “ahead of the rest of the world.”
iPS Cell Market Growth
Based on the market dynamics described, BioInformant estimates the market for induced pluripotent stem cells (iPSCs) is estimated to reach over $6 billion by the end of 2022. Since the discovery of iPSCs, a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells.
Major driving factors for growth of the market include increasing popularity for the use of iPSCs in drug development and discovery, personalized medicine, and drug toxicity testing.
iPS Cell Clinical Trials
The launch of two human trials involving iPSC-derived therapeutics indicates clinical progress with the cell type. RIKEN initiated a trial involving iPSC-derived cell sheets to treat patients with macular degeneration in Japan in 2013.
1. RIKEN | Macular Degeneration
Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), Dr. Takahashi and her team began investigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration as early as 2013.
Unfortunately, the study was suspended in 2015 due to safety concerns. In June 2016 RIKEN Institute announced that it would resume the clinical study, this time using allogeneic iPSC-derived cells, because of cost and time efficiencies.
2. Cynata Therapeutics | GvHD Trial
Cynata continues to prioritise operational progress relating to its world first clinical trial of CYP-001 for the treatment of GvHD. #cynatatherapeutics #stemcells pic.twitter.com/hC6yfEWzOW
— Cynata Therapeutics (@cynatastemcells) November 15, 2017
Cynata Therapeutics also approved in September 2016 to initiate a GvHD trial involving iPSC-derived mesenchymal stem cells. The trial involves centers in the UK and Australia. Cynata iPSC-derived cell product is called “CYP-001.”
3. Osaka University | Cardiac Cells
It appears that the next clinical frontier will be iPS cell-derived cardiac cells. On 16 May, Nature News reported that “Japan’s health ministry gave doctors at Osaka University permission to take sheets of tissue derived from iPS cells and graft them onto diseased human hearts.”
The team of Japanese doctors, led by cardiac surgeon Yoshiki Sawa at Osaka University, will use iPS cells to “create a sheet of 100 million heart-muscle cells.” It will be the second clinical application of iPS cells in Japan and third worldwide (RIKEN, Cynata Therapeutics, and now, Osaka University).
iPS Cell Companies
The growing popularity of iPSC technology has also been attracting investments from the commercial sector. Notably, in December 2016, Bayer AG and Versant Ventures formed a start-up named BlueRock Therapeutics focused on iPSCs therapy. The company raised funding of USD $225 million, the largest iPSC financing round ever.
Cellular Dynamics International
The largest company manufacturing iPS cells is Cellular Dynamics International, a Fujifilm company. The company is widely known as Fujifilm CDI.
Fujifilm CDI manufactures biologically relevant human cells derived from iPS cells. Its iCell® and donor-specific MyCell® Products are “highly pure, highly reproducible, and available in industrial quantity to enable drug discovery, toxicity testing, stem cell banking, and cell therapy development.”
Ncadia in Europe
Within Europe, the largest iPS cell developer and manufacturer is Ncardia, a company formed in September 2017 by the merger of Axiogenesis and Pluriomics. Ncardia is the largest supplier in Europe and the second largest iPS cell company in the world after Fujifilm CDI.
Ncardia is a private company with operations in Europe and the US that “produces and commercializes high-quality, fully functional hiPSC derived cardiovascular and neuronal cell types.” It also develops electrophysiology, biochemistry, and contraction based assays to support drug development and discovery.
iPSC Commercialization
There are also dozens of other suppliers of iPS cell lines, differentiated cell types, kits, assays, reprogramming services, and more.
Today, methods for commercializing iPS cells are still being explored, as clinical studies investigating them remain low in number. One of the greatest challenges is to establish standards across the industry for cell quality and functionality in order to protect patient safety.
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