Induced Pluripotent Stem Cells – a Next Frontier in Regenerative Medicine?
Stem cells can self-renew and differentiate into functional cells and tissue. Pluripotent stem cells can differentiate into any specific adult cell types. This is not new knowledge, and stem cells have – inherently – been used for instance in bone marrow transplantation to treat certain types of cancer for decades. What is a more recent development is using methods to reprogram (induce) fully differentiated cells to pluripotent stem cells, i.e. reversing differentiation in vitro. These stem cells can then be programmed to grow tissue of our preference. The advantage is that there is no need for a (matching) cell donor or immunosuppression, since donor and recipient are the same person.
Simplified example:
What can be done with this technology? Of course, there is the research aspect, for example to better understand cell regulation, to examine drug effects and to model diseases[1].
But perhaps of more interest to the insurance sector is the notion that induced pluripotent stem cells could be used therapeutically for numerous diseases. It is entirely conceivable that induced pluripotent stem cells can be programmed to become pancreatic Beta Islet cells able to produce insulin (potentially curing Type 1 Diabetes). It is also conceivable that heart failure can be approached with induced stem cells replacing dysfunctional heart muscle with healthy muscle fibers. It is a technology that is able to restore normal organ function (which is the ultimate goal of Regenerative Medicine). And there is hope that this field of medicine will play a major role in health care in the not-too-distant future.
Many clinical studies are underway, with a large proportion of them conducted in the United States, Japan and China. They cover for example diseases of the eye, the nervous system, heart and blood vessels, blood as well as malignancies[2].
However, there are some problems. For instance, there is the risk of an induced stem cell behaving like a cancer cell, reproducing in an uncontrolled fashion[3]. Researchers may also find themselves in an ethical minefield: Each cell contains genetic information that is specific to the cell donor. And the genes also hold particulars of the donor’s immediate relatives. So, privacy protection is critical. It is also important to obtain the donor’s consent regarding the use of stem cells and differentiated cells. Furthermore, the quality of the laboratory work needs constant scrutiny, in order to avoid mishaps in the complex medical specialty of stem cell research and stem cell therapy.[4]
At this stage, reprogramming somatic cells and then manipulating the resulting stem cells is rather expensive. The estimated cost of generating useable induced pluripotent stem cells for a single patient is approximately USD 50,000, and the cost of generating the eventual cell product is estimated to be around USD 800,000[5]. But one could speculate that – like with many other new technologies – the price will come down once clinical application becomes more mainstream.
The value of the global induced stem cell market was about USD 2.7B in 2022 and is expected to reach well over USD 6B by 2032[6].
What are the implications for insurers? No doubt, Health Insurers will start to see claims for induced stem cell therapy. Questions will arise about the possible experimental nature of the treatment, as well as whether it is medically necessary. So we will have to understand which treatments are approved for what clinical indication. We also need to know for which medical conditions induced pluripotent stem cell therapy is not only approved, but also an appropriate option.
On a broader level, stem cell therapy will probably be a game-changer in that it has the potential to truly re-establish healthy tissue and fully functioning organs. As insurers, we can expect an impact in many areas, including Disability, Mortality and Long Term Care.
From a medical perspective, induced pluripotent stem cells provide an exciting new path to treat diseases and injuries; from an insurance perspective, it is about understanding the risks and opportunities that come with this new technology.
[1] The Scientist Magazine: Brush Up: What Is Stemness and Pluripotency? , September, 2022
[2] National Library of Medicine, Pluripotent Stem Cells in Clinical Setting-New Developments and Overview of Current Status – PubMed (nih.gov), September 2022
[3] Cell Stem Cell 27, Pluripotent Stem Cell-Based Cell Therapy-Promise and Challenges, October, 2020
[4] National Library of Medicine, Research and therapy with induced pluripotent stem cells (iPSCs): social, legal, and ethical considerations – PubMed (nih.gov), November 2019
[5] Science Direct, Integrated generation of induced pluripotent stem cells in a low-cost device, January 2019
[6] Research and Markets, Global Induced Pluripotent Stem Cell Market Report 2023: (globenewswire.com), May 2023
Simplified example:
What can be done with this technology? Of course, there is the research aspect, for example to better understand cell regulation, to examine drug effects and to model diseases[1].
But perhaps of more interest to the insurance sector is the notion that induced pluripotent stem cells could be used therapeutically for numerous diseases. It is entirely conceivable that induced pluripotent stem cells can be programmed to become pancreatic Beta Islet cells able to produce insulin (potentially curing Type 1 Diabetes). It is also conceivable that heart failure can be approached with induced stem cells replacing dysfunctional heart muscle with healthy muscle fibers. It is a technology that is able to restore normal organ function (which is the ultimate goal of Regenerative Medicine). And there is hope that this field of medicine will play a major role in health care in the not-too-distant future.
Many clinical studies are underway, with a large proportion of them conducted in the United States, Japan and China. They cover for example diseases of the eye, the nervous system, heart and blood vessels, blood as well as malignancies[2].
However, there are some problems. For instance, there is the risk of an induced stem cell behaving like a cancer cell, reproducing in an uncontrolled fashion[3]. Researchers may also find themselves in an ethical minefield: Each cell contains genetic information that is specific to the cell donor. And the genes also hold particulars of the donor’s immediate relatives. So, privacy protection is critical. It is also important to obtain the donor’s consent regarding the use of stem cells and differentiated cells. Furthermore, the quality of the laboratory work needs constant scrutiny, in order to avoid mishaps in the complex medical specialty of stem cell research and stem cell therapy.[4]
At this stage, reprogramming somatic cells and then manipulating the resulting stem cells is rather expensive. The estimated cost of generating useable induced pluripotent stem cells for a single patient is approximately USD 50,000, and the cost of generating the eventual cell product is estimated to be around USD 800,000[5]. But one could speculate that – like with many other new technologies – the price will come down once clinical application becomes more mainstream.
The value of the global induced stem cell market was about USD 2.7B in 2022 and is expected to reach well over USD 6B by 2032[6].
What are the implications for insurers? No doubt, Health Insurers will start to see claims for induced stem cell therapy. Questions will arise about the possible experimental nature of the treatment, as well as whether it is medically necessary. So we will have to understand which treatments are approved for what clinical indication. We also need to know for which medical conditions induced pluripotent stem cell therapy is not only approved, but also an appropriate option.
On a broader level, stem cell therapy will probably be a game-changer in that it has the potential to truly re-establish healthy tissue and fully functioning organs. As insurers, we can expect an impact in many areas, including Disability, Mortality and Long Term Care.
From a medical perspective, induced pluripotent stem cells provide an exciting new path to treat diseases and injuries; from an insurance perspective, it is about understanding the risks and opportunities that come with this new technology.
[1] The Scientist Magazine: Brush Up: What Is Stemness and Pluripotency? , September, 2022
[2] National Library of Medicine, Pluripotent Stem Cells in Clinical Setting-New Developments and Overview of Current Status – PubMed (nih.gov), September 2022
[3] Cell Stem Cell 27, Pluripotent Stem Cell-Based Cell Therapy-Promise and Challenges, October, 2020
[4] National Library of Medicine, Research and therapy with induced pluripotent stem cells (iPSCs): social, legal, and ethical considerations – PubMed (nih.gov), November 2019
[5] Science Direct, Integrated generation of induced pluripotent stem cells in a low-cost device, January 2019
[6] Research and Markets, Global Induced Pluripotent Stem Cell Market Report 2023: (globenewswire.com), May 2023
