The paper is about the stand of the National Institutes of Health, (NIH), on Human Stem Cell Research. It entails what to be done when the involved parties want to carry out the same. NIH considers funding research only on human embryonic stem cell lines obtained from human embryos. NIH must always be satisfied with health status of the parents providing the embryos. The parents must always test negative of sexually transmitted diseases especially HIV and AIDS. The sperm and the oocyte donors for IVF must always meet the tissue donor eligibility requirements. To achieve this, numerous medical screens are conducted to meet the requirements.
In clinical allowed by FDA, it was observed that NIH utilized a certain line referred to as H1. H1 is a line that arises because of inadequately examined donors. FDA allowed this use of an investigational product under an Investigational New Drug application in a clinical experiment. Phase 1 trials are crucial in the realization of the therapeutic developments despite the huge amount of money involved. One hundred and eight lines on the stem cell registry show that one hundred and four of the lines arose from embryos donated by the biological parents. A minimum of eight lines were derived from the donor gametes involved.
Left over embryos from the fertility clinics is the origin of the research that requires funding. This has turned fertility patients into unwitting research participants whose credibility as tissue donors is undetermined. This is the report issued by the FDA Tissue Donor Guidance. One of the unintended consequences of this that the vast majority of the lines made to date do not meet the FDA’s requirements for commercializable initial materials. This article is informatory since a number of individuals like Lyerly A.D, Steinhauser K. Namey E and Orru C.D among others have contributed in this work.
Reference
Jonlin C. Erica. (2013) Institute of Stem cell and Regenerative Medicine, University of Washington, Seattle. Retrieved from http:/dx.doi.org/10.1016/j.stem.2013.12.014
