National Guidelines for Stem Cell Research
On April 26, 2005 a federal document was released describing the national guidelines for human embryonic stem cell research in order to regulate how stem cell research is performed and to minimize controversy. This document was complied by the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine and the National Research Council. Premise for creating the document was based on the fact that human embryonic stem cells may have the ability to provide great improvements in human health. Although the potential for lifestyle improvement is great, stem cell research must be regulated to prevent inappropriate application of this relatively new discovery.
Above is an image of an embryonic stem cell in an extracellular matrix.
Where do the Human Embryos come from?
Assisted Reproductive Technology (ART) was created over 20 years ago to overcome fertility problems. ART utilizes In Vitro Fertilization (IVF), which is fertilization of an egg by a sperm outside the body (for example, in a petri dish). Many ART procedures result in an excess amount of embryos and the people involved in creating those embryos have the option of cryopreserving them to be stored for future attempts to enable pregnancy. Over 400,000 of these cryopreserved embryos are stored in the United States alone. Therefore, once the “owners” of the embryo choose to terminate treatment, they have a number of options for their excess embryos. One of those options is to donate them for research purposes. The only way to get these embryos (which are in the form of blastocysts) into labs for research is to get consent from all of the gamete donors for the blastocyst to be used in research.
Above is am image of an eight cell embryo obtained from an In Vitro Fertilization Program (IVF).
How are Embryos Stored?
Storage, maintenance, and distribution of cell lines must also adhere to certain national standards. There exist national stem cell banks** (and international stem cell banks as well) that store stem cells according to legal requirements. They are established for various functions to ensure legitimate protocol. On the privacy plane, stem cell banks ensure that the rights of the gamete donors have not been abused and make sure that proper consent forms by all gamete donors are completed and accurate. These banks also limit the number of embryos that any one institution can receive, which is vital in regulating abuse of stem cell research. Further regulation of storing and obtaining tissues lies in the requirement that any identifiable tissue is required to pass an Institutional Review Board (IRB) review at the collection site.
Quality Assurance of Embryos
Safety, security, and risk assessments are performed on the management side of this issue in order to ensure appropriate handling and storage of the embryos. This is vital to maintain high quality stem cells for research and clinical studies. Validating submitted tissues, culturing and expanding cell lines, process control, packaging for distribution and documentation are all processes that are monitored and constantly checked by the quality management team of the stem cell banking facility. Detailed reports of every aspect for every tissue that enters a banking facility are required in order to assure accuracy and enable tracking. It is increasingly vital for research institutions to obtain high quality cell lines as they approach their in vivo testing. Poor stem cell quality could create adverse effects on the test subject’s body and put the subject’s life in danger.
All information obtained from Guidelines for Human Embryonic Stem Cell Research.
-Amy
