scholarly journals Perspectives on Challenges to Cell Therapy Development in Taiwan: Strengthening Evidential Standards and Ways Forward

2021 ◽  
Vol 9 ◽  
Author(s):  
Bilikis Aderonke Abolarinwa ◽  
Malissa Kay Shaw ◽  
Chung-Hsi Lee
Keyword(s):  
Regenerative Medicine ◽  
Cell Therapy ◽  
Clinical Evidence ◽  
Structured Interviews ◽  
Regulatory Oversight ◽  
Policy Interventions ◽  
Cell Technologies ◽  
Clinical Innovation ◽  
Medical Institutions ◽  
Emerging Issues

Over the past years, the field of regenerative medicine and cell therapy has garnered much interest, extending beyond the bench to broader use, and commercialization. These therapies undergo stringent regulatory oversight as a result of their complexities and potential risk across different jurisdictions. Taiwan’s government, with the aim of developing the country as a hub for regenerative medicine in Asia, enacted a dual track act to promote the development of regenerative and cell therapy products. This qualitative study used purposive sampling to recruit sixteen experts (Twelve respondents from medical institutions and four respondents from the industry) to understand their perspectives on one of the regulatory tracks which governs the medical use of cell technologies and challenges regarding its implementation. Semi-structured interviews were conducted, transcribed, coded and thematically analyzed. Three major themes emerged from the analysis: 1) Perceptions of the “Special Regulation for Cell Therapy” 2) Emerging issues and controversies on the medical use of cell technologies in private clinics, and 3) Challenges impeding the clinical innovation of cell technologies. As reported by the experts, it was clear that the special regulation for cell therapy was aimed at legalizing the clinical use of cell therapy in a similar fashion to an evidence-based pathway, to promote clinical innovation, ensure manufacturing consistency, and improve oversight on cell-based therapies. Thus, the regulation addresses the issues of safety concerns, patient’s access and stem cell tourism. However, the limited approved cell techniques, quality control during cell processing, time, and criteria used in evaluating applications in addition to the need to develop evidential standards for clinical evidence are some of the difficulties faced. Thus, policy interventions on funding, educational resources, training, and regulatory clarity addressing these challenges may positively impact clinical innovation of cell therapy in Taiwan.

scholarly journals Cell technologies in treatment of human intervertebral disc hernia: perspectives

2015 ◽  
Vol 3 (2) ◽  
pp. 202-207
Author(s):  
A. Ustymenko
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Cell Therapy ◽  
Intervertebral Disc ◽  
Neurological Deficit ◽  
Experimental Studies ◽  
Locomotor Apparatus ◽  
Disc Hernia ◽  
Cell Technologies ◽  
Methods Of Treatment

The intervertebral disc hernia is distinguished one of the diseases of the human locomotor apparatus that causes pain, neurological deficit and functional disorders.Inefficency of concervative treatment and repeated appeals for medical help after surgery have urged on the need for exploration of some new more effective methods of treatment aimed not only at weakening degenerative processes and pain but also at renewing disc function and its height maintenance. Achievements of regenerative medicine and tissue engineering promote development of new efficient methods of cell therapy. The results of their application in experimental studies on animals give us hope for their successful use in humans.

scholarly journals Online seminars as an information source for direct-to-consumer stem cell therapy

2021 ◽  
Author(s):  
Mirna Hassoun ◽  
Sidney Golub ◽  
Sheldon Greenfield ◽  
Joshua D Grill ◽  
Brian J Cummings
Keyword(s):  
Stem Cell ◽  
Cell Therapy ◽  
Stem Cell Therapy ◽  
Clinical Evidence ◽  
Scientific Evidence ◽  
Information Source ◽  
The Internet ◽  
Regulatory Oversight ◽  
Direct To Consumer

Aim: To attend stem-cell (SC) seminars hosted by US-based direct-to-consumer SC businesses either in person or via online ‘webinars’ to determine accuracy and regulatory oversight of the advertised SC therapies. Methods: The therapeutic claims, costs, risks, scientific evidence in support of a therapy and any regulatory oversight were collated using pre-established checklists. Participation consisted of one live attendance of a seminar, and following COVID-19 restrictions, review of seven recorded presentations available on the internet from SC businesses. Results & conclusion: None of the SC therapies advertised by direct-to-consumer clinics reviewed were supported by proper clinical evidence nor substantiated by peer reviewed literature.

Healthcare System in the Arctic Zone of Russia. Known and Emerging Issues and Solutions to Them

2019 ◽  
pp. 3-20
Author(s):  
V.N. Leksin
Keyword(s):  
Metallurgical Industry ◽  
Healthcare Services ◽  
The Arctic ◽  
Russian Arctic ◽  
Arctic Zone ◽  
Shift Workers ◽  
The North ◽  
Medical Institutions ◽  
Emerging Issues ◽  
The Impact

The impact on healthcare organization on the territory of Russian Arctic of unique natural and climatic, demographic, ethnic, settlement and professional factors of influencing the health of population, constantly or temporarily living on this territory is studied. The necessity is substantiated of various forms and resource provision with healthcare services such real and potential patients of Arctic medical institutions, as representatives of indigenous small peoples of the North, workers of mining and metallurgical industry, military personnel, sailors and shift workers. In this connection a correction of a number of All-Russian normative acts is proposed.

scholarly journals iPSC technology-based regenerative medicine for kidney diseases

2021 ◽  
Author(s):  
Kenji Osafune
Keyword(s):  
Regenerative Medicine ◽  
Cell Therapy ◽  
Kidney Development ◽  
Disease Modeling ◽  
Kidney Diseases ◽  
Collecting Duct ◽  
Current Status ◽  
Renal Tubules ◽  
Discovery Research ◽  
Drug Discovery Research

AbstractWith few curative treatments for kidney diseases, increasing attention has been paid to regenerative medicine as a new therapeutic option. Recent progress in kidney regeneration using human-induced pluripotent stem cells (hiPSCs) is noteworthy. Based on the knowledge of kidney development, the directed differentiation of hiPSCs into two embryonic kidney progenitors, nephron progenitor cells (NPCs) and ureteric bud (UB), has been established, enabling the generation of nephron and collecting duct organoids. Furthermore, human kidney tissues can be generated from these hiPSC-derived progenitors, in which NPC-derived glomeruli and renal tubules and UB-derived collecting ducts are interconnected. The induced kidney tissues are further vascularized when transplanted into immunodeficient mice. In addition to the kidney reconstruction for use in transplantation, it has been demonstrated that cell therapy using hiPSC-derived NPCs ameliorates acute kidney injury (AKI) in mice. Disease modeling and drug discovery research using disease-specific hiPSCs has also been vigorously conducted for intractable kidney disorders, such as autosomal dominant polycystic kidney disease (ADPKD). In an attempt to address the complications associated with kidney diseases, hiPSC-derived erythropoietin (EPO)-producing cells were successfully generated to discover drugs and develop cell therapy for renal anemia. This review summarizes the current status and future perspectives of developmental biology of kidney and iPSC technology-based regenerative medicine for kidney diseases.

scholarly journals Cell Therapy and Bioengineering in Experimental Liver Regenerative Medicine: In Vivo Injury Models and Grafting Strategies

2021 ◽  
Author(s):  
G. Amato ◽  
T. Saleh ◽  
G. Carpino ◽  
E. Gaudio ◽  
D. Alvaro ◽  
...  
Keyword(s):  
Regenerative Medicine ◽  
Cell Therapy ◽  
Cell Delivery ◽  
Effective Strategies ◽  
Multiple Strategies ◽  
End Stage ◽  
Therapy Strategies ◽  
Injury Models ◽  
Experimental Liver

Abstract Purpose of Review To describe experimental liver injury models used in regenerative medicine, cell therapy strategies to repopulate damaged livers and the efficacy of liver bioengineering. Recent Findings Several animal models have been developed to study different liver conditions. Multiple strategies and modified protocols of cell delivery have been also reported. Furthermore, using bioengineered liver scaffolds has shown promising results that could help in generating a highly functional cell delivery system and/or a whole transplantable liver. Summary To optimize the most effective strategies for liver cell therapy, further studies are required to compare among the performed strategies in the literature and/or innovate a novel modifying technique to overcome the potential limitations. Coating of cells with polymers, decellularized scaffolds, or microbeads could be the most appropriate solution to improve cellular efficacy. Besides, overcoming the problems of liver bioengineering may offer a radical treatment for end-stage liver diseases.

Regenerative medicine and traumatic brain injury: from stem cell to cell-free therapeutic strategies

2021 ◽  
Author(s):  
Lianxu Cui ◽  
Yasmeen Saeed ◽  
Haomin Li ◽  
Jingli Yang
Keyword(s):  
Traumatic Brain Injury ◽  
Stem Cells ◽  
Stem Cell ◽  
Brain Injury ◽  
Regenerative Medicine ◽  
Cell Therapy ◽  
Therapeutic Strategies ◽  
Study Data ◽  
Health Concern ◽  
Standardized Treatment

Traumatic brain injury (TBI) is a serious health concern, yet there is a lack of standardized treatment to combat its long-lasting effects. The objective of the present study was to provide an overview of the limitation of conventional stem cell therapy in the treatment of TBI and to discuss the application of novel acellular therapies and their advanced strategies to enhance the efficacy of stem cells derived therapies in the light of published study data. Moreover, we also discussed the factor to optimize the therapeutic efficiency of stem cell-derived acellular therapy by overcoming the challenges for its clinical translation. Hence, we concluded that acellular therapy possesses the potential to bring a breakthrough in the field of regenerative medicine to treat TBI.

The Iranian National Guideline for Cell Therapy and Regenerative Medicine

2021 ◽  
Author(s):  
Javad Verdi ◽  
Mahdi Shadnoush ◽  
Ghasem Janbabai ◽  
Alireza Shoae-Hassani ◽  
Seyed Abdolreza Mortazavi-Tabatabei ◽  
...  
Keyword(s):  
Regenerative Medicine ◽  
Cell Therapy ◽  
National Guideline

scholarly journals Problems of formalization of the mentoring institute in healthcare and ways of solving them

2021 ◽  
Vol 65 (5) ◽  
pp. 461-466
Author(s):  
Yulia V. Burdastova
Keyword(s):  
Healthcare Sector ◽  
Highly Qualified ◽  
Structured Interviews ◽  
Sociological Study ◽  
Department Of Health ◽  
Medical Institutions ◽  
Long Time ◽  
Quality Of Medical Care ◽  
Mentoring System

Introduction. This study focuses on the formalization of the institution of mentoring in health care. The mentoring system in Russia has existed for a long time. Still, there is a particular interest in this topic since the requirements for the quality of medical care are changing, new challenges arise in the healthcare sector, and reducing staff turnover and retaining highly qualified specialists in the workplace arises. Targets and goals. The aim of the study is to clarify the need for institutional consolidation of the institution of mentoring. The tasks of the work included identifying factors motivating or demotivating medical workers to participate in the mentoring system, as well as the search for problems of formalizing the institution of mentoring. Material and methods. The author conducted a sociological study in Moscow: a mass questionnaire survey among doctors and nurses in 6 medical institutions subordinated to the Department of Health of the city of Moscow and a series of in-depth structured interviews with representatives of medical organizations in charge of mentoring in their organizations (17). Analysis of quantitative data was carried out using the construction of classification trees using the CHAID method. Results. The main issue that experts propose to spell out when formalizing mentoring is the skills and abilities. Employee willingness to become mentors varies. The study found that physicians over the age of 27 are most likely to become mentors convinced of the need to introduce and expand mentoring in the workplace. Young doctors under the age of 27 are less likely to take on the mentoring function due to a lack of confidence in their qualifications, as well as older colleagues who are dissatisfied with the working conditions in the workplace and do not consider it necessary to introduce or expand a mentoring system in their organization. Conclusion. The study showed that experts have a positive attitude to formalizing the institute of mentoring, noting that there should be a single document of a recommendatory nature.

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