Regulation of Stem Cell-Based Research in India in Comparison with the US, EU and other Asian Countries: Current Issues and Future Perspectives

2020 ◽  
Vol 15 (6) ◽  
pp. 492-508
Author(s):  
Jobin Jose ◽  
Teena George ◽  
Aaron M. Thomas

Stem cell therapy is applicable for repair and replacement of damaged cells and tissues. Apart from transplanting cells to the body, the stem cell therapy directs them to grow new and healthy tissues. Stem cells in the area of regenerative medicines hold tremendous promise that may help to regenerate the damaged tissues and heal various diseases like multiple sclerosis, heart diseases, Parkinson’s disease, and so on. To prove the safety, efficacy, and for the requirement of a licence for manufacturing and sale, all the stem cell therapies should pass the required criteria and undergo certain examinations of the regulatory agencies. The regulatory authorities review the manufacturing procedures of products to assure its purity and potency. This review summarizes the comparative critical evaluations of existing regulations and developments on the stem cells research in India, USA, EU and Asian regions and also discusses the challenges that have to be overcome and the important points that should be understood to position India as a source of the perspective nation in stem cells around the world.

2020 ◽  
pp. 1-2
Author(s):  
Shantha A R

Stem cells are the building blocks of life. They have remarkable potential to regenerate and develop into many different cell types in the body during early life and growth. They are also a class of undifferentiated cells that are able to be differentiated into specialized cells types. Stem cells are characterized by certain features such as totipotency, pluripotency, multipotency, oligopotent and unipotency. The history of stem cell research had an embryonic beginning in the mid 1800s with the discovery that few cells could generate other cells. In the 1900s the first stem cells were discovered when it was found that cells generate blood cells. Nowadays, stem cell therapy is under research and till now, a very few stem cell therapies have been regarded as safe and successful. It is also found that stem cell therapy cast a number of side effects too. The cost of the procedure too is expensive and is not easily affordable.


2021 ◽  
Author(s):  
Sevil Kestane

This overview was evaluated by the development of diabetic retinopathy (DR) and the stem cell therapy approach. DR is a microvascular complication of diabetes mellitus, characterized by damage to the retinal blood vessels leading to progressive loss of vision. However, the pathophysiological mechanisms are complicated and not completely understood yet. The current treatment strategies have included medical, laser, intravitreal, and surgical approaches. It is known that the use of mesenchymal stem cells (MSC), which has a great potential, is promising for the treatment of many degenerative disorders, including the eye. In retinal degenerative diseases, MSCs were ameliorated retinal neurons and retinal pigmented epithelial cells in both in vitro and in vivo studies. Stem cell therapies show promise in neurodegenerative diseases. However, it is very important to know which type of stem cell will be used in which situations, the amount of stem cells to be applied, the method of application, and its physiological/neurophysiological effects. Therefore, it is of great importance to evaluate this subject physiologically. After stem cell application, its safety and efficacy should be followed for a long time. In the near future, widespread application of regenerative stem cell therapy may be a standard treatment in DR.


2021 ◽  
Vol 9 (09) ◽  
pp. 363-369
Author(s):  
Tripti Goarya ◽  
◽  
Chandrakala Janghel ◽  

The stem cells, derived from the cord blood are hematopoietic stem cells. These have immense potential in curing blood related disorders like blood cancers, thalassemia etc. These can be useful in treating tissue related disorders of heart, bone, spinal cord etc. Stem cells are characterized by the ability to renew through mitotic cell division and differentiate into a diverse range of specialized cell types. Stem Cells are the basic building blocks of the body and have the potential to replenish other cells and give rise to number of tissues which constitute different organs. To conduct the study, 60 antenatal mothers are selected the age range of subjects was 21 to 40 years. The need for the study arises after knowing those antenatal mothers were unaware and having inadequate knowledge regarding cord blood collection for stem cell therapy. The above facts created an interest to conduct a structured teaching programme to assess its effectiveness on knowledge and attitude of antenatal mother on cord blood collection for stem cell therapy. The pretest, the mean score of knowledge is 13.2 mean % is 50.7, & attitude is 31.58, mean % 63.16, the post test the mean score of knowledge is 18.1, mean % is 69.65. Attitude 38.05, mean % 76.1.


Author(s):  
Qi Zhang ◽  
Xin-xing Wan ◽  
Xi-min Hu ◽  
Wen-juan Zhao ◽  
Xiao-xia Ban ◽  
...  

Stem cell therapies have shown promising therapeutic effects in restoring damaged tissue and promoting functional repair in a wide range of human diseases. Generations of insulin-producing cells and pancreatic progenitors from stem cells are potential therapeutic methods for treating diabetes and diabetes-related diseases. However, accumulated evidence has demonstrated that multiple types of programmed cell death (PCD) existed in stem cells post-transplantation and compromise their therapeutic efficiency, including apoptosis, autophagy, necroptosis, pyroptosis, and ferroptosis. Understanding the molecular mechanisms in PCD during stem cell transplantation and targeting cell death signaling pathways are vital to successful stem cell therapies. In this review, we highlight the research advances in PCD mechanisms that guide the development of multiple strategies to prevent the loss of stem cells and discuss promising implications for improving stem cell therapy in diabetes and diabetes-related diseases.


2020 ◽  
Vol 15 (5) ◽  
pp. 1679-1688
Author(s):  
Alex HP Chan ◽  
Ngan F Huang

Although stem cell therapy has tremendous therapeutic potential, clinical translation of stem cell therapy has yet to be fully realized. Recently, patient comorbidities and lifestyle choices have emerged to be important factors in the efficacy of stem cell therapy. Tobacco usage is an important risk factor for numerous diseases, and nicotine exposure specifically has become increasing more prevalent with the rising use of electronic cigarettes. This review describes the effects of nicotine exposure on the function of various stem cells. We place emphasis on the differential effects of nicotine exposure in vitro and as well as in preclinical models. Further research on the effects of nicotine on stem cells will deepen our understanding of how lifestyle choices can impact the outcome of stem cell therapies.


Author(s):  
Hyun-Min Cho ◽  
Je-Yoel Cho

AbstractMassive death of cardiomyocytes is a major feature of cardiovascular diseases. Since the regenerative capacity of cardiomyocytes is limited, the regulation of their death has been receiving great attention. The cell death of cardiomyocytes is a complex mechanism that has not yet been clarified, and it is known to appear in various forms such as apoptosis, necrosis, etc. In ischemic heart disease, the apoptosis and necrosis of cardiomyocytes appear in two types of programmed forms (intrinsic and extrinsic pathways) and they account for a large portion of cell death. To repair damaged cardiomyocytes, diverse stem cell therapies have been attempted. However, despite the many positive effects, the low engraftment and survival rates have clearly limited the application of stem cells in clinical therapy. To solve these challenges, the introduction of the desired genes in stem cells can be used to enhance their capacity and improve their therapeutic efficiency. Moreover, as genome engineering technologies have advanced significantly, safer and more stable delivery of target genes and more accurate deletion of genes have become possible, which facilitates the genetic modification of stem cells. Accordingly, stem cell therapy for damaged cardiac tissue is expected to further improve. This review describes myocardial cell death, stem cell therapy for cardiac repair, and genome-editing technologies. In addition, we introduce recent stem cell therapies that incorporate genome-editing technologies in the myocardial infarction model.


2018 ◽  
Vol 6 (3) ◽  
pp. 114-119 ◽  
Author(s):  
Magdalena Rojewska ◽  
Małgorzata Popis ◽  
Maurycy Jankowski ◽  
Dorota Bukowska ◽  
Paweł Antosik ◽  
...  

AbstractStem cells are cells that have the potential to replicate and/or differentiate, becoming any tissue. This process could be theoretically repeated indefinitely and can be used to create or fix damaged parts any organ. There are many in vivo factors that cause stem cells to replicate and differentiate. Many of these interactions and mechanisms are still unknown. In vitro models have been successful in inducing stem cells to differentiate into the desired lineage using controlled methods. Recently, epithelial tissue has been successfully created using scaffolds on which stem cells are grown in vitro and then transplanted into the host. This transition creates significant problems. This is because in vitro -grown stem cells or stem cell-derived tissues are created in an isolated environment where virtually every aspect can be monitored and controlled. In vivo monitoring and controlling is significantly more difficult for a plethora of reasons. Cells in the body are constantly exposed to many signals and molecules which affect them. Many of the mechanisms behind these interactions and reactions are known but many others are not. As the corpus of knowledge grows, stem cells become closer to being applied in a clinical setting. In this paper, we review the current evidence on stem cell therapy in regenerative medicine and some of the challenges this field faces.


2017 ◽  
Vol 1 (1) ◽  
pp. 17
Author(s):  
Siska Damayanti ◽  
Rina Triana ◽  
Angliana Chouw ◽  
Nurrani Mustika Dewi

Introduction: Each cell in human body is assigned with a specialized function to perform.  Before a cell becomes specialized, it is a stem cell. Stem cell research and therapy is progressing dramatically these days. Stem cell therapy holds enormous treatment potential for many diseases which currently have no or limited therapeutic options. Unfortunately, this potential also comes with side-effects. In this review, the positive and negative effects of regulation of stem cells will be explained.Content: Stem cells are undifferentiated cells that have potential to develop into many different cell types in the body during early life and growth. The type of stem cells are embryonic stem cells, induced pluripotent stem cells, somatic stem cells, foetal stem cells and mesenchymal stem cells. Stem cell transplantation is one form of stem cell therapy, it comes with different sources, and those are autologous and allogenic transplantation stem cells. In an autologous transplant, a patient’s own blood-forming stem cells are collected, meanwhile in an allogeneic transplant, a person’s stem cells are replaced with new stem cells obtained from a donor or from donated umbilical cord blood.Summary: Its abilities to maintain undifferentiated phenotype, self-renewing and differentiate itself into specialized cells, give rise to stem cell as a new innovation for the treatment of various diseases. In the clinical setting, stem cells are being explored in various conditions, such as in tissue repair and regeneration and autoimmune diseases therapy. But along with its benefit, stem cell therapy also holds some harm. It is known that the treatment using stem cell for curing and rehabilitation has the risk in tumor formation.


2014 ◽  
Vol 42 (3) ◽  
pp. 679-687 ◽  
Author(s):  
Rukmani Sridharan ◽  
Jeffrey M. Karp ◽  
Weian Zhao

For the last decade, stem cell therapies have demonstrated enormous potential for solving some of the most tragic illnesses, diseases and tissue defects worldwide. Currently, more than 1300 clinical trials use stem cell therapy to solve a spectrum of cardiovascular, neurodegenerative and autoimmune diseases (http://www.clinicaltrials.gov, Jan 2014, search term: stem cell therapy; only currently recruiting and completed studies are included in the search). However, the efficacy of stem cell transplantation in patients has not been well established, and recent clinical trials have produced mixed results. We attribute this lack of efficacy in part to an incomplete understanding of the fate of stem cells following transplantation and the lack of control over cell fate, especially cell-homing and therapeutic functions. In the present review, we present two of our recently developed technologies that aim to address the above-mentioned bottlenecks in stem cell therapy specifically in the areas of MSCs (mesenchymal stem cells): (i) aptamer-based cell-surface sensors to study cellular microenvironments, and (ii) mRNA engineering technology to enhance the homing and immunomodulatory efficacy of transplanted stem cells. The first engineering strategy aims to elucidate the basic cellular signalling that occurs in the microenvironment of transplanted stem cells in real time. The second technique involves a simple mRNA transfection that improves the homing and anti-inflammatory capability of MSCs. Although we have specifically applied these engineering techniques to MSCs, these strategies can be incorporated for almost any cell type to determine and control the fate of transplanted stem cells.


2021 ◽  
Vol 2 (1) ◽  
pp. 143-158
Author(s):  
Sara Faour ◽  
Aarthi Ashok

Parkinson’s disease (PD) is referred to as a neurodegenerative disease which is a disease that targets specific brain regions and is characterized by neuronal death. PD is believed to be caused by the loss of nerve cells in the substantia nigra (SN), a dopamine releasing area (Dickson, 2012). Current treatments are directed at alleviating pain symptoms and slowing down the progression of disease, however, no cure currently exists. Recent advances in stem cell therapies raise new possibilities to treat neurodegenerative diseases. Stem cells have the ability to differentiate into neural cells, and thus, could potentially be used to restore neurogenesis and neuroplasticity (Lunn et al., 2011). There exist several cell types that can be applied in therapy including embryonic stem cells (ESCs), neural stem cells (NSCs), induced pluripotent stem cells (iPSCs), and mesenchymal stem cells (MSCs). PD which has localized neural degeneration to the SN may serve as a better model for stem cell therapy and displays greater success when compared to other neurodegenerative diseases that spread to several brain regions (Vasic et al., 2019). This review aims to discuss the several approaches used in stem cell therapy as well as the current challenges and shortcomings of this cell-based therapy.


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