Embryo Project Encyclopedia Articles

The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials. In the document, the FDA recommended that anyone who could become pregnant be excluded from early-phase clinical trials to minimize risks to a potential fetus. After the FDA published the document, investigators excluded women from clinical trials. The document ultimately prevented women of reproductive capacity from participating in early phase clinical trials, which affected women’s health research.

Charles Knowlton was a physician and author who advocated for increased access to information about reproduction in the nineteenth century in the US. Throughout his early medical education, Knowlton was particularly interested in anatomy and on several instances robbed graves for bodies to dissect. In 1832, Knowlton authored The Fruits of Philosophy, a pamphlet that contained detailed descriptions of the reproductive organs and information on conception and methods to control reproduction. Knowlton circulated his work among his patients until it was republished in Boston, Massachusetts, in 1832. For publishing a book on sex and methods of birth control, Knowlton was convicted of breaking obscenity laws, which prevented the transmission of obscene materials. After his death, social activists Charles Bradlaugh and Annie Besant republished his work in London, England. Knowlton’s writing about sex and birth control allowed individuals to understand and take control of their reproduction and initiated a public discussion about obscenity laws.

In 1993, the NIH published the Revitalization Act that established guidelines for minorities’ and women’s participation in clinical research. Before the 1990s, investigators largely excluded women from their research based on the 1979 guidance from the US Food and Drug Administration, or FDA. The FDA urged investigators to exclude any woman who was or could become, pregnant to protect the woman and any developing fetuses from harm. Between 1979 and 1993, several other US governmental agencies urged investigators to increase the number of women in their clinical research to improve the state of women’s healthcare. After Congress passed the National Institutes of Health Revitalization Act, hereafter Revitalization Act of 1993, investigators who used NIH funds for clinical research were required to include both women and minorities in their clinical research. The Revitalization Act established the Office of Research on Women’s Health headquartered in Washington, DC and required investigators to include women in their clinical research, thus improving the quality of women’s health research.

Annie Wood Besant was a social activist who advocated for women’s access to birth control as well as marriage reform, labor reform, and Indian Nationalism in the nineteenth century in England and India. In her early career, Besant was involved in various social and political advocacy organizations including the National Secular Society, the Malthusian League, and the Fabian Society. Besant gave many public lectures and authored various articles in support of secularism, workers’ rights and unionization, and women’s rights. In 1877, Besant and her colleague Charles Bradlaugh republished the pamphlet The Fruits of Philosophy, by Charles Knowlton, on reproduction and contraception. Besant and Bradlaugh were tried for violating the obscenity law that prohibited the publication of obscene material, including sex and contraception. Later in her life, she converted to theosophy and moved to India where she joined the Theosophical Society. In India, Besant campaigned for Indian self-rule and became the president of the Indian National Congress. Besant, through republication of The Fruits of Philosophy and many public lectures and writings on women’s rights, expanded public knowledge of birth control.

Charles Bradlaugh was as a political and social activist in the seventeenth century in England. He held leadership positions in various organizations focused on social and political activism including the Reform League, the London Secular Society, the newspaper National Reformer, and the National Secular Society. Throughout his career, Bradlaugh advocated for better conditions for the working poor, and for the separation of government and religion. The British government prosecuted him numerous times for violating laws prohibiting the publication, sale, and transmission of antireligious, antigovernment, and obscene materials. In 1877, Bradlaugh and another secularist, Annie Besant, republished The Fruits of Philosophy, a pamphlet about contraceptive techniques originally whose author was physician Charles Knowlton. In the nineteenth century, individuals did not have access to information on sex, reproduction, and contraception, as much of society argued such information encouraged immoral behavior. Bradlaugh and Besant were tried for publishing information on sexual anatomy, conception, and methods to control reproduction. Bradlaugh expanded public knowledge of reproduction and contraception, and initiated the process of dismantling the obscenity laws.

In 2015, biologist Helena D. Zomer and colleagues published the review article “Mesenchymal and Induced Pluripotent Stem Cells: General Insights and Clinical Perspectives” or “Mesenchymal and Induced Pluripotent Stem Cells” in Stem Cells and Cloning: Advances and Applications. The authors reviewed the biology of three types of pluripotent stem cells, embryonic stem cells, or ESCs, mesenchymal stem cells, or MSCs, and induced pluripotent stem cells, or iPS cells. Pluripotent stem cells are a special cell type that can give rise to other types of cells and are essential for development. The authors describe the strengths and weaknesses of each type of stem cell for regenerative medicine applications. They state that both MSC and iPS types of stem cells have the potential to regenerate tissues among many other therapeutic possibilities. In their article, Zomer and colleagues review the potential for MSCs and iPS cells to reshape the field of regenerative and personal medicine.

In 2017, Angiolo Gadducci, Silvestro Carinelli, and Giovanni Aletti published, "Neuroendocrine Tumor of the Uterine Cervix: A Therapeutic Challenge for Gynecologic Oncologists," hereafter, "Neuroendocrine Tumor" in the journal, Gynecologic Oncology. The authors conducted a systematic review of existing literature that documented the symptoms, diagnosis, staging, treatment, and outcomes of women diagnosed with neuroendocrine tumors, or cervical NETs, which are tumors with cells similar to cells from both the hormonal and the nervous system. Based on high mortality rates and the rarity of cervical NET diagnoses, the authors conclude that cervical NETs present a challenge for physicians in terms of devising novel ideas for treatment. By compiling the treatment methods and resulting outcomes of different studies, the authors presented evidence that there is a need for new forms of treatment to reduce the number of women dying from cervical NETs each year.

Aristotle studied developing organisms, among other things, in ancient Greece, and his writings shaped Western philosophy and natural science for greater than two thousand years. He spent much of his life in Greece and studied with Plato at Plato's Academy in Athens, where he later established his own school called the Lyceum. Aristotle wrote greater than 150 treatises on subjects ranging from aesthetics, politics, ethics, and natural philosophy, which include physics and biology. Less than fifty of Aristotle's treatises persisted into the twenty-first century. In natural philosophy, later called natural science, Aristotle established methods for investigation and reasoning and provided a theory on how embryos generate and develop. He originated the theory that an organism develops gradually from undifferentiated material, later called epigenesis.

Vasovasostomy is a microsurgical procedure to restore fertility after vasectomy, a surgery that sterilizes the patient by severing the vas deferentia, the tubes that carry the sperm from the testes to the penis. After a vasectomy, a patient may have various reasons for wanting to reverse the procedure, such as new opportunities for having children or a new romantic partnership. A vasovasostomy involves reestablishing the flow of sperm through the vas deferens by reconnecting the severed ends of the tube. In 1919, in the United States, William C. Quinby performed the first recorded successful vasovasostomy. Modern improvements on the surgery have led to its adoption as a microsurgery, a procedure that involves a microscope and specialized microscopic instruments. Surgical research over the twentieth century into reconnecting a blocked vas deferens and the resulting microsurgical technique for vasovasostomy has provided a way for people to regain their fertility after a vasectomy.