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Somatic Genetic Therapy

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Somatic Genetic Therapy

Somatic genetic therapy is a treatment option that utilizes the body’s own cells to alter or correct a defective gene responsible for disease. It has already shown promise in treating rare diseases with no other available therapies.

Somatic gene therapy involves the transfer of a section of DNA into somatic cells, which are not part of the germ line (cells producing sperm or eggs). While this can alter a patient’s genes, it will not affect their sperm or eggs and does not pass along any altered genetic material to subsequent generations.

CRISPR, an advanced tool for DNA editing, allows scientists to edit a person’s genome without causing harm and correct specific genes or even entirely sections of genetic code. Furthermore, they can introduce beneficial new genes such as disease-fighting ones into circulation.

However, the technology is not without its drawbacks. For instance, it can be challenging to deliver new genes into diverse cell types throughout the body, creating a challenge for scientists who use it.

Despite these obstacles, the technology is becoming more and more effective, potentially leading to its use in treating more patients with rare diseases like adenosine deaminase deficiency or familial hypercholesterolemia – conditions with no other treatments available.

Although some cases of this treatment have been successful, there are significant risks of morbidity and mortality associated with it. Furthermore, concerns have been raised regarding its potential effect on future generations as well as ethical questions raised by its use.

Some believe God is the creator of nature and should not interfere with its order. Therefore, they believe it’s wrong to alter a person’s genes for medical treatment or any condition. On the other hand, some argue that genetic engineering can be justified when necessary to safeguard individuals or communities’ health.

Regulating somatic genome editing has been a contentious topic for several years. Both the US National Academies and UK Nuffield Council on Bioethics have released reports outlining their perspectives, but more work needs to be done in order to define exactly how this field should be regulated and what core principles should apply.

In the United States, the FDA has a longstanding policy of applying its regulatory framework to biologic products. It permits product development by academic and commercial sponsors while adhering to FDA requirements for safety and efficacy; yet they recognize that scientific knowledge will eventually determine which regulatory approach is most appropriate.

The FDA’s regulations are largely built upon the concept of risk-benefit analysis and must be adjusted to account for the more granular science-based approach now being employed to evaluate emerging forms of gene and somatic cell therapy. This is an appropriate course of action that should facilitate product development while staying true to FDA’s traditional role in biological agent regulation.

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