27 more hESC Lines Approved
National Institutes of Health (NIH) director Francis Collins approved 27 more human embryonic stem cell lines as eligible for federal funding on 12/14/09, bringing the total number of new lines to 40 — almost double the number of previously okayed lines under the administration of former President George W. Bush.
“I am hopeful that this will be an important boost to the healing work envisioned by the National Institutes of Health in its support of this field of research,” Collins said in a statement. However, Collins has limited the federal funding of these lines to the use specifically stated on the consent forms: diabetes-related pancreatic research (The Scientist).
Bottom Line: The move came after a committee advising the NIH director recommended that 27 of 28 lines; all part of a single submission from Harvard University be approved with such limitations. Consent for the derivation of the 28th line came during a lapse in the institution’s IRB*, and thus was not recommended for approval. As of yet, the NIH has not responded to the committee’s request for guidelines addressing the broader use of embryos derived for a specific purpose:
- Research using hESCs is already yielding information about the complex events that occur during human development. Researchers hope that eventually cells differentiated from hESCs may be used to treat a myriad of diseases, conditions, and disabilities and to test the safety of new drugs in the laboratory,
- More than 30 NIH grants funded in the 2009 fiscal year totaling more than $20 M proposed to use hESCs; these grants have been restricted until approved lines became available on the NIH registry. With this announcement and following NIH approval, these principal investigators may obtain registry-listed hESCs, if they are appropriate for their project, from the owners of the lines and proceed with their research. This group of grants includes research using hESCs for the therapeutic regeneration of diseased or damaged heart muscle cells, developing systems for the production of neural stem cells and different types of neurons from hESCs in culture, and developing a cell culture system for the large scale production and self-renewal of hESCs,
- In addition, a number of Challenge Grant applications, which could be funded through the American Recovery and Reinvestment Act in the 2010 fiscal year, proposed to use hESCs. Researchers are examining other topics that could benefit from the use of hESCs and are encouraged to apply for funding using these approved lines,
- The 27 Harvard University cell lines join 13 from Children’s Hospital Boston added earlier this month to a NIH stem cell registry. Human embryonic stem cells are the precursors to every type of tissue. Cell “lines”, or colonies, are grown from the collected inner cells of an embryo destroyed in the process of collection. Researchers hope to study organ development, screen drugs and someday perhaps grow rejection-free transplant tissues from the cells (Multiple Sources),
- An Institutional Review Board (IRB*), also known as an independent ethics committee (IEC) or ethical review board (ERB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects . In the US, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory (Wikipedia).
- The approval puts 40 cell lines on the NIH registry, beating the Bush Administration 2001 to 2008 total of 21 lines on its registry .