Bioethical conflicts of gene therapy: a brief critical review

Freire, José Ednésio da Cruz; Medeiros, Suelen Carneiro de; Neto, A. Viana; Júnior, José Telmo Valença; Sousa, Antônio Juscelino Sudário; Rocha, Antônio José; Menezes, Léa Maria Bezerra de

doi:10.1590/1806-9282.60.06.008

Cited by 6 publications

(4 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…With these various clinical trials being carried out to test the efficacy of the gene therapy approaches there is lack of sufficient evidence to support the effectiveness of this modality as a definitive treatment for head and neck cancer. Some of the barriers to the success of such a therapy that need to be taken care of are optimization of vectors that can transfer DNA to the target cells, diminish the viral vectors associated biological risks like toxicity and immunogenicity, prevention of undesirable heterologous gene or vector expression [4,5] . However continued diligent research efforts to combine gene therapy with the preexisting treatment protocol such as chemotherapy, radiotherapy and surgery is the need of the hour.…”

Section: Resultsmentioning

confidence: 99%

“…The high morbidity and mortality associated with head and neck cancer led to the introduction of cancer gene therapy which refers to the introduction of new genetic material to human cells for a therapeutic purpose. In the early years, gene therapy was focused on monogenic diseases such as severe combined immunodeficiency, hemophilia and certain enzyme deficiencies which could be corrected by replacing the "missing gene" but more recently clinical trials for gene therapy have been directed towards cancer (64.3%)with a total of 1,223 trials being carried out globally [4,5] .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Gene Therapy in Head and Neck Cancer

Gaonkar¹,

Patankar²,

Bhandare³

et al. 2016

Journal of Tumor

View full text Add to dashboard Cite

Advancements in the field of molecular biology have stimulated the interest of the scientists and clincians worldwide who believe that genetic manipulation can be a potential cure for cancer. Gene therapy is one such therapy that is significantly applied in human cancer which involves transferring genetic material into a host cell via a viral or non-viral vector, immunotherapy or by manipulation of the tumor microenvironment to reduce angiogenesis.It is not only being considered as a therapeutic strategy to treat cancer but also as a medium to counter the post radiation side-effects. More recently it has been used as a means to prevent the progression of potentially malignant diseases into cancer thereby proving to be a potential candidate for improving survival rates in cancer patients. This review aims to provide insight into the field of cancer gene therapy as applicable to oral squamous cell carcinoma and oral premalignancies that may have far reaching effects on the way a cancer patient is managed.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Gene Therapy in Head and Neck Cancer

Gaonkar¹,

Patankar²,

Bhandare³

et al. 2016

Journal of Tumor

View full text Add to dashboard Cite

show abstract

“…Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [33]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [34].…”

Section: Clinical Trials: Epidemiological and Human Genetics Studymentioning

confidence: 99%

Clinical Trials and Clinical Research: A Comprehensive Review

Kandi¹,

Vadakedath²

2023

Cureus

View full text Add to dashboard Cite

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

show abstract

“…Consequences of such approaches are yet to be determined, in terms of safety or misuse. In this context, the widespread use of gene therapy may have the potential to make society less accepting of people who are different ( 139 , 141 , 142 ).…”

Section: Gene Therapy Medicinal Productsmentioning

confidence: 99%

Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework

2017

View full text Add to dashboard Cite

Advanced therapy medicinal products (ATMPs) have a massive potential to address existing unmet medical needs. Specifically, gene therapy medicinal products (GTMPs) may potentially provide cure for several genetic diseases. In Europe, the ATMP regulation was fully implemented in 2009 and, at this point, the Committee for Advanced Therapies was created as a dedicated group of specialists to evaluate medicinal products requiring specific expertise in this area. To date, there are three authorized GTMPs, and the first one was approved in 2012. Broad research has been conducted in this field over the last few decades and different clinical applications are being investigated worldwide, using different strategies that range from direct gene replacement or addition to more complex pathways such as specific gene editing or RNA targeting. Important safety risks, limited efficacy, manufacturing hurdles, or ethical conflicts may represent challenges in the success of a candidate GTMP. During the development process, it is fundamental to take such aspects into account and establish overcoming strategies. This article reviews the current European legal framework of ATMPs, provides an overview of the clinical applications for approved and investigational GTMPs, and discusses critical challenges in the development of GTMPs.

show abstract

Bioethical conflicts of gene therapy: a brief critical review

Cited by 6 publications

References 36 publications

Gene Therapy in Head and Neck Cancer

Gene Therapy in Head and Neck Cancer

Clinical Trials and Clinical Research: A Comprehensive Review

Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework

Contact Info

Product

Resources

About