What are some issues involved in gene therapy?
What are some issues involved in gene therapy?
Gene therapy has some potential risks. A gene can’t easily be inserted directly into your cells….Risks
- Unwanted immune system reaction. Your body’s immune system may see the newly introduced viruses as intruders and attack them.
- Targeting the wrong cells.
- Infection caused by the virus.
- Possibility of causing a tumor.
What are the regulations on gene therapy?
Today, gene therapy products are regulated by FDA’s Center for Biologics Evaluation and Research (CBER). FDA requires submission of an IND prior to initiating clinical studies, and an approved biologics license application (BLA) to market the product in the United States.
What are the controversial issues relating to gene therapy?
The ethical questions surrounding gene therapy and genome editing include: How can “good” and “bad” uses of these technologies be distinguished? Who decides which traits are normal and which constitute a disability or disorder? Will the high costs of gene therapy make it available only to the wealthy?
What are the ethical issues surrounding gene therapy?
Ethical questions surrounding gene therapy include: (1) How to distinguish between “good” and “bad” uses of gene therapy? (2) Who does decide which traits are normal and which are disabilities or handicaps? (3) Would the high cost of gene therapy make it available only to the rich? (4) Will the widespread use of gene …
What is the biggest problem in gene therapy?
Gene therapy poses one of the greatest technical challenges in modern medicine. It is very hard to introduce new genes into cells of the body and keep them working.
What are the issues concerning gene therapy and stem cells?
Limitations of gene and cell therapy These include possibility of immune and inflammatory responses from the host, toxicity from over expression of the transgene or lack of enough expression and risk of insertional mutagenesis in the case of the integrating viral vectors.
How are cell therapies regulated?
The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.
What are the social implications of gene therapy?
Social implications of gene therapy It would provide new options for medical ther- apy and imply new responsibilities for making such decisions fairly and for the benefit of both individuals and society.
What are the risks of human genetic engineering?
Potential Harms to Human Health
- New Allergens in the Food Supply.
- Antibiotic Resistance.
- Production of New Toxins.
- Concentration of Toxic Metals.
- Enhancement of the Environment for Toxic Fungi.
- Unknown Harms.
- Gene Transfer to Wild or Weedy Relatives.
- Change in Herbicide Use Patterns.
What are some of the ethical issues related to stem cell research and gene therapy?
Table 1
| Phase of research | Ethical issues |
|---|---|
| 1. Payment to oocyte donors | |
| 2. Medical risks of oocyte retrieval | |
| 3. Protecting reproductive interests of women in infertility treatment | |
| Use of stem cell lines derived at another institution | Conflicting legal and ethical standards |
What are the issues concerning gene therapy and stem cell therapy?
What is one of the difficulties of human gene therapy?
Difficulties include delivery of the vector to the cell, lack of persistent gene ex- pression in targeted cells, and immune responses to viral gene products, transgenes, or cells targeted by the vectors.
