Abstract
There is much to be investigated about the specific characteristics of stem cells and about the efficacy and safety of the new drugs based on this type of cells, both embryonic as adult stem cells, for several therapeutic indications (cardiovascular and ischemic diseases, diabetes, hematopoietic diseases, liver diseases). Along with recent progress in transference of nuclei from human somatic cells, as well as iPSC technology, has allowed availability of lineages of all three germ layers genetically identical to those of the donor patient, which permits safe transplantation of organ-tissue-specific adult stem cells with no immune rejection. The main objective is the need for expansion of stem cell characteristics to maximize stem cell efficacy (i.e. the proper selection of a stem cell) and the efficacy (maximum effect) and safety of stem cell derived drugs. Other considerations to take into account in cell therapy will be the suitability of infrastructure and technical staff, biomaterials, production costs, biobanks, biosecurity, and the biotechnological industry. The general objectives in the area of stem cell research in the next few years, are related to identification of therapeutic targets and potential therapeutic tests, studies of cell differentiation and physiological mechanisms, culture conditions of pluripotent stem cells and efficacy and safety tests for stem cell-based drugs or procedures to be performed in both animal and human models in the corresponding clinical trials. A regulatory framework will be required to ensure patient accessibility to products and governmental assistance for their regulation and control. Bioethical aspects will be required related to the scientific and therapeutic relevance and cost of cryopreservation over time, but specially with respect to embryos which may ultimately be used for scientific uses of research as source of embryonic stem cells, in which case the bioethical conflict may be further aggravated.
Highlights
A great interest has arisen in research in the field of stem cells, which may have important applications in tissue engineering, regenerative medicine, cell therapy, and gene therapy because of their great therapeutic potential, which may have important applications [1,2].Cell therapy is based on transplantation of live cells into an organism in order to repair a tissue or restore lost or defective functions
Induced pluripotent stem cells Induced pluripotent stem cells from somatic cells are revolutionizing the field of stem cells
In recent decades, a great interest has arisen in research in the field of stem cells, which may have important applications in tissue engineering, regenerative medicine, and cell- and gene therapy
Summary
A great interest has arisen in research in the field of stem cells, which may have important applications in tissue engineering, regenerative medicine, cell therapy, and gene therapy because of their great therapeutic potential, which may have important applications [1,2]. Embryonic stem cells have the advantages of being pluripotent, easy to isolate, and highly productive in culture, in addition to showing a high capacity to integrate into fetal tissue during development By contrast, their disadvantages include immune rejection, the possibility that they differentiate into inadequate cell types or induce tumors, and contamination risks. If the biological material is human embryonic stem cells (hES), there is no standard method for characterization, but some of their specific characteristics may be assessed, including the nucleus-cytoplasm ratio, number of nucleoli and morphological characteristics of the colony, growth rate, percent clonogenicity, in vitro embryoid body formation, and in vitro teratoma formation after subcutaneous implantation in immunodeficient mice Clinical use of this type of cells always requires control of their in vitro differentiation into multipotent or fully differentiated cells with tumorogenic potential. The research or hospital center, and the principal investigator of the project of an informed consent that explains in detail the potential risks and benefits and informs on the rights and safeguards, is established as an indispensable condition
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