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Reprogramming of the differentiated cells into the stem cells and some other applications opened the door to a new age of regenerative medicine. Regulatory, medical, and aesthetic aspects are on the agenda.
Both in theory and reality a controlled cultivation of the embryonic and pluripotent stem cells from the stratified (dissected) cells has long been considered to be impossible. Nevertheless, they were able to realize this process in 2006 for the first time using the fibroblasts of mice. Following year brought a chance to carry out the same experiment with the human cells.
Japanese stem cell researcher Shinya Yamanaka was awarded Nobel Prize in the field of medicine in 2012 for his method of producing the so-called induced pluripotent stem cells, abbreviated iPSC.
Ten years have passed since the discovery. Today, it’s not an option to imagine the stem cells researches without using the iPSCfor development of the models of the cells diseases or testing systems while creating new medications. Besides, iPSC have important therapeutic potential in the development of new treatment techniques in the regenerative medicine. We expect autologous iPSCand cells replicated from them to improve the immune and medical transplant compatibility. iPSC-drugs also give a chance to avoid or eliminate the usual consequences of the allogeneic tissue transplantation.
That is why the importance of the iPSC discovery for the research and medical field is being specifically emphasized by the academics and politicians. It is reflected in the EU’s support programs at German federal level and on the level of federal provinces. Increase in the number of publications and patents and the first clinical study prove the importance of iPSC discovery.
Booking Health offers the following stem cell treatment programs:
- Chronic pancreatitis
- Diabetes melitus
- Diabetic neuropathy
- Diabetic retinopathy
- Dilated and ischemic cardiomyopathy
- Erectile dysfunction (impotence)
- Immunodeficiency disorders
- Liver cirrhosis (fibrosis)
- Multiple sclerosis
- Oncological diseases
- Optic nerve atrophy
- Parkinsons disease
- Pulmonary fibrosis
Existing issues of regulatory, medical and aesthetic character
Legal, medical, and aesthetic debates on iPSC were mainly drifting by this timearound the field of basic research. Together with that, the regulatory, medical, and aesthetic terms of iPSC medications administration did not draw enough attention before this therapy has been started. Only eight years later, after the method of iPSCallocation was developed, the research program for the treatment of age-related macular degeneration (AMD) has been approved in Japan in 2014. A layer of the retinal pigment epithelium cells was transplanted to a woman. Layer was derived from the woman’s skin cells and iPSC. Meanwhile, complications were not observed.
But, the research has been stopped in the early 2015 as the cells prepared for transplantation were identified with the cancer-causing mutation. Nevertheless, the study has to be continued. Clinical studies based on iPSC are going to be carried on Parkinson’s disease treatment techniques.
Legal status: medications for the new therapies
Talking about the research, the question is from the legal point of view which are the medications considered based on iPSC. Here, from the legal point, we are talking about advanced therapy medicinal products (ATMP) according to the European Directive on ATMP. The Directive on ATMP gives a definition of the somatic cell and genetic treatment medications, tissue products processed via biotechnology and supervise their proper use.
Inside the ATMP group iPSC based therapy products represent the “tissue products after the biotech processing”. IPSC couldn’t be possibly produced in big clinical volumes untill now “foot-print-free”, i.e. without any residual genetically confirmed changes in the reprogrammed cells.
Therefore, genetic products should also be considered in terms of regulatory, medical, and aesthetical assessment of iPSC-medications based on the applicable reprogramming methods. Specifically, alternate recommendations should be considered to ensure reliability, quality, and effectiveness which will be established on the different risk potential compared to other ATMP.
Anyway, not every genetically modified iPSC will be an agent for the gene therapy. Moreover, iPSC therapy should make it possible to create the substitutes for the cells and tissues that suffered from the degenerative effects as a result of an accident or aging. Meanwhile, the combination of iPSC-technology and gene therapy could have been successfully evaluated on the animal models or human cells more than once (e.g.for sickle cell anemia or Parkinson’s disease). Whereby, it is necessary to have in future such treatment options and the latest achievements in “gene medication” for the regulatory, medical, and aesthetical assessment.
However, the evolution of the treatment based on human embryonic stem cells has an almost ten-year time benefit compared to the iPSC. In recent years, embryonic stem cells research has reached the level of clinical studies in other countries. Therapy on the basis of stem cells remains, though, allogeneic that could be further connected to the immune and medical treatment. Besides, the theme of deriving and using human embryonic cells got to the aesthetic dialogues around it. This has already led to the banned patenting of such inventions in Europe. Considering up-to-date legal status, it has to be stated that application of human embryonic stem cells is also prohibited by the pharmaceutical law among other issues.
Ethical suitability: needs to be, but less critisizing
It is not clear yet, whether the treatment on the basis of human embryonic stem cells will ensure or not their practical implementation. Here, iPSC discovery seems to be much more promising for the therapeutic transplantation. Since iPSCare derived from the cells of people who were already born, the discussion about the moral and, finally, legal statuses of using human embryos compared to iPS-cells doesn’t matter.
Individual body cells (pluripotent or produced) are legally accounted as material, not human embryos. Therefore, the iPS-cells’ development and appliance are basically possible for the creation of new therapies and within the clinical research framework. Necessary ethical evaluation can be seen in the section 40, paragraph 1, second half; section 42, paragraph 1 of Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelngesetz - AMG)as well as in the other clinical studies by Commission on the Ethics that is responsible for the verification according to the legislation of federal German lands.
Altogether, there are no any certain legal remarks existing as for clinical research on the use of the cell-based medicines. Hence, §§ 40 ff. of Arzneimittelngesetz (Medicine Act) is the one to regulate and put the frames for the clinical studies involving the use of iPS-cells or their derivatives. According to §40, paragraph 1 and §77, paragraph 2 of Medicine Act (Arzneimittelngesetz), Paul Ehrlich Institut (PEI) is responsible for the permitting cell-based clinical studies. However, special subsidiary legislations and recommendations by European Medicines Agency (EMA) must be taken into account for stem-cells based drugs verification.
Requirment of the specific information and documentation
While deriving reprogrammed body cells it is necessary to take into account not only the legal regulations about medicines of § 20 b in Medicines Act (Arzneimittelngesetz), but also to consider the regulations by Transplantation Act - Gesetz über die Spende, Entnahme und Übertragung von Organen und Geweben(Transplantationsgesetz or TPG),and by Regulation on Tissues of TPG (TPG-GewV) - Verordnung über die Anforderungen an Qualität und Sicherheit der Entnahme von Geweben und deren Übertragung nach dem Transplantationsgesetz, with their legal duties, especially with regard to the clarification or vigilance of cells and tissues. Eligibility of TPG appears from § 1, paragraph 2, half 1 of TPG.
According to the law, donorship (donation) and sampling of human tissues for their further transplantation, as well as tissue transfer and preparation of these activities are subject to the Transplantation Law (TPG). Section 8, paragrapgh № 1 of TPG regulatesthe the process of somatic cells biopsy for iPS-cells derivation, their usage, volume, and the obligatory fixing of information on autologous iPSC-therapeutic drugs. By their nature, they do not differ from the interpretations on other (transplantation) interventions. It can be explained by the born-people nature of somatic cells used for the pluripotential cells production. Cells are not totipotential and are able to develop independently with the corresponding environmental conditions and not like a human embryo. As follows, they cannot have their own rights, moral and/or legal status compared to the born human.
Regulatory requirements for the manufacturing of therapeutic agents based on iPSC differ from the requirements for the manufacturing of other drugs for new treatments (ATMP).Talking about iPSC based drugs we mainly mean the ATMP (advanced therapy medicinal products). Therefore, legal authorization for medicinal products accordingto § 13, paragraph 1 of Medicines Act (AMG) will be always obligatory to produce iPS-based therapeutic products due to the actual law. Such products should be produced according to the GMP standard.
Specific requirements on the launching
Launching process of the iPSC-based therapeutic products is defined either by EU centralized admissions requirements or by the provisions on the so-called “hospital exception”, that is valid in Germany only. If the production of the mentioned medicine is elective and industrial, the EU permit should be received after filing an application to the European Medicines Agency (EMA). However, if stem cell treatment in Germany deals with the individually produced drugs for the certain patient, application for permit should be filed to Paul Ehrlich Institut.
Regenerative medicine stepped into the new epoch thanks to stem cells programming and their wide variety of applications. After the debates on the use of this technique in the fundamental area it still has to be figured out whether the existing regulatory, medical, and ethic frames are able to adequately cover the iPS-cells medical practice. At the same time, already existing iPS-technology developments represented by transdifferentiation should also be taken into the account. Transdifferentiation allows skipping the iPS-cells and creatinganother cell type directly out of differentiated cells. Finally, invivoreprogramming technique is being successfully applied in the animal models.
Inducedpluripotent (pluripotential) stem cells (iPSC)
It was long believed that cells are able to develop in a single direction – from a stem cell to the differentiated cell. Thus, stem cells research had no any alternative to the ethically argued human embryonic stem cells.
In 2006, Japanese doctor Shinya Yamanaka form the Kyoto University broke a new ground in medical history. Together with his team he discovered a new way of derivating the induced pluripotential stem cells, abbreviated iPSC, and in 2012 he has received Nobel Prize in the field of medicine.
Yamanaka derived the fibroblasts from the mice skin with the help of retroviral transduction. Then, he activated four transcriptional factors 0ct3/4, Sox2, c-Myc and Klf4 in such way that reprogrammed cells got the form and peculiarities of the embryonic stem cells. He gave a name to the produced cells: “induced pluripotential stem cells” (iPSC).
Further research proved that iPS-cells are able to differentiate into all cell types of the adult body just like the embryonic stem cells. In 2007, Yamanaka and other groups of scientists successfully performed experiments on the human cells. Today, the researchers use the iPS-cells technique to derive cells of patients suffering from the genetically conditioned diseases that are able to differentiate into all types of cell. Special iPS-cells are designed to help in development and testing of new drugs for Parkinson’s disease or amyotrophic lateral sclerosis (ALS) treatment.
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