The Foundation was formed in 1996 as a Massachusetts Public Charity to support research that could not be done in major biomedical research institutions in Massachusetts for political reasons. By the year 2000, the need for the Foundation’s independent, non-federally funded research laboratory expanded to include human stem cell research.
A Brief History
The Foundation was formed in 1996 through the efforts of men and women whose lives were altered by blood products tainted with the AIDS virus (Human Immunodeficiency Virus, HIV) and Hepatitis C virus. Faced with unprecedented disease obstacles, the men and women insisted that biomedical technology be developed to fight their infections, and allow them to conceive children of their own. Because they were relentless and insisted that the National Institutes of Health fund research on their diseases, nearly two dozen anti-viral drugs were developed in less than a decade. For the first time in history, two virus epidemics (AIDS and Hepatitis C) are being fought with drugs instead of vaccines.
In sharp contrast, research to ensure the safety of conception by assisted reproductive technologies in general was not funded by the National Institutes of Health because of the U.S. Congress decisions in 1996 and 1998 that research on fertilized human eggs “…is meritorious and should be done for society…, but will not be funded by taxpayer dollars.”
For this reason, the men and women themselves raised the money to fund the Special Program of Assisted Reproduction. Within two years, Foundation scientists developed technology to protect against virus transmission at conception. As a result, Baby Ryan was born in 1999 to a healthy Mom and a Dad with hemophilia who was infected with Hepatitis C and HIV by tainted blood factors. (see the story by Stephen Smith, Minnesota Public Radio at http://americanradioworks.publicradio.org/features/evading_virus/concryan.html)
With the help of eight collaborating clinics, twenty nine more babies were safely born to couples with infectious disease infertility by January, 2004. All babies and mothers are infection-free. The success of the Foundation’s Special Program of Assisted Reproduction demonstrates the speed and efficiency with which public charities can bring about biomedical advances.
Although originally criticized for its pioneering work to assist couples with infectious diseases safely conceive, the Foundation received a Prize Paper award from the Society of Assisted Reproductive Technology of the American Society of Reproductive Medicine in 2007 (ASRM Prize Paper (pdf). As of the end of 2007, the number of collaborating clinics had grown to 31, with 74 babies born, all Moms and babies testing free of disease, and as of July, 2013, the number of collaborating clinics has grown to 76 and the number of babies born to 173.
Stem Cell Research with Human Eggs
Stem cell therapy could transform medical treatments for “incurable” diseases such as spinal cord injury, heart failure, Parkinson’s disease, kidney failure, retinal degeneration, and diabetes. (FAQ’s about stem cells). The confusion surrounding “human embryonic stem cells” and “human therapeutic cloning” research has led to strong negative public debate. This has strengthened the will of Congress and President Bush to not allow the National Institutes of Health to fund research on either fertilized human eggs or unfertilized human eggs used to develop stem cells.
In 2001, the Foundation implemented a unique program for recruiting women willing to donate their eggs for stem cell research. The goal is to take advantage of scientific advances that lead to activation of eggs that have not been exposed to sperm. With more research it will be possible to derive therapeutic stem cells from unfertilized eggs, thus avoiding both ethical and moral controversies, as well as the tissue compatibility problems associated with deriving stem cells from fertilized human eggs. The guidelines for the donor program were originally developed by the Ethics Advisory Board for Advanced Cell Technology chaired by Dr. Ronald Green, Dartmouth College. Dr. Ann Kiessling, Bedford Research Foundation director, was a founding member of Advanced Cell Technology’s Ethics Advisory Board. Some of the work of that board was reported in the Hastings Center Report in June, 2002 (TheHastingsCenter.org). The goal of the Foundation’s egg donor program is to safely promote research using unfertilized human eggs to derive stem cells (Guidelines for Research with Human Eggs). Because the Foundation has no financial stake in the outcome of the research, the health and safety of the egg donors is the primary consideration. “Human Eggs: the Need, the Risks, the Politics,” The Burrill Stem Cell Report (pdf)
Eggs obtained through the Foundation’s Egg Donor Program for Dr. Jose Cibelli’s research team at Advanced Cell Technology allowed the development of laboratory procedures for activating human eggs two ways: artificially, termed parthenogenesis, and following transplantation of nuclei from other cells, termed nuclear transplantation, or ovasomagenesis. An early report of the work appeared in the Journal of Regenerative Medicine in the fall of 2001 (pdf). Although no human stem cell lines were obtained as a result of the research reported in 2001, major progress was made, and the principle was proven that human eggs could respond to laboratory manipulations in ways developed for animal eggs, including monkeys.
To continue to move the work forward, Bedford Research Foundation launched a fund-raising campaign for human embryonic stem cell research. Major contributors were Irvin and Diane Naylor of Pennsylvania, in addition to dozens of others. The contributions funded more experiments designed to solve the problems associated with the nuclear transplant technology. Because of the screening and medical procedures put in place to protect women donating eggs for research, each egg donor cycle carries a price tag of $25,500.
The egg donor program for stem cell research was suspended pending new funding/research partners. BRF has an active pool of dedicated women willing to undergo egg donation for stem cell research when funding is available. In 2005, Drs. Cibelli and Kiessling collaborated with a clinical team in Buenos Aires, Argentina, to conduct the first studies of parthenogenetically activating human eggs that had been cryo-preserved. The work was published in 2007 (“Human parthenogenetic blastocysts derived from noninseminated cryopreserved human oocytes” DeFried (pdf)) Foundation scientists are currently carrying out detailed molecular biology studies of gene expression in activated eggs to improve the efficiency of stem cell derivation from unfertilized eggs (parthenotes) collected from pre-menopausal women in need of stem-cell therapy, as well as for other tissue-matched patients.
Because BRF is privately funded, BRF scientists can take advantage of the more recently described lines of human embryonic stem cells. The goal is to develop the laboratory methods to generate cells with characteristics of human eggs from human embryonic stem cells. The human egg-like cells may be a valuable, safe source of cells for the production of stem cells from parthenotes and nuclear transplant technology (FAQs). For additional details, see Stem Cell Research.
The research to improve the safety of reproduction by HIV-infected men led to novel approaches for diagnosing other male reproductive tract disorders, such as diseases of the prostate. Several research programs are underway, including new ways to detect other infections, such as bacteria, in semen specimens. These new approaches could lead to rapid advances in understanding and diagnosing diseases of the prostate, including prostatitis and prostate cancer. Download our Fact Sheet to get a quick overview of the Foundation (pdf).
At no time in the history of biomedical research has private funding been more important.
The current administration has banned federal research support of new lines of pluripotent stem cells. Thus, although several states have voted in favor of pluripotent (“embryonic”), the moratorium on federal funding means that not only will stem cell research involving human eggs be entirely dependent on private funding, so will research to improve the safety and efficiency of assisted reproduction for the tens of thousands of women undergoing fertility treatments each year, and the babies that result. This need applies to all couples, including those with sexually transmissible diseases, seeking medical assistance in achieving pregnancy. Of particular interest to the Foundation is to raise funds to help offset the costs of family building by the men with hemophilia that were infected with HIV and Hepatitis C by tainted clotting factors.
With respect to prostate research, budgetary crises have stalled the increases in biomedical research funds allocated by congress to the National Institutes of Health. Thus, the new developments in diagnosing and understanding diseases of the male reproductive tract will not receive federal funding for a few years. The rapid success of the SPAR program indicates similar rapid advances may be possible through private funding of Bedford Research Foundation scientists.
The Foundation is responding to the lack of federal research support in urgent areas of stem cell development, novel prostate disease diagnostics, and In Vitro Fertilization, by sponsoring educational activities and raising funds to support research.
The Foundation is seeking trustees, benefactors, and fundraisers for these urgent goals.