Legislative Update: Stem Cell Research

By Danny Restivo 3/30/17

Since the 1950s, doctors and other medical professionals had used stem cells extracted from bone marrow to help treat Leukemia patients. As technology evolved, scientists began to see human embryos as a prime source for developing healthy stem cells. However, with Roe vs. Wade, as well as the first “test tube baby,” the American public began raising questions on ethical grounds. In 1996, Congress passed the Dickey-Wicker Amendment, which prohibits 320px-human_embryonic_stem_cells_only_afederal funding for research using human embryos. Four years later, the NIH released guidelines on the use of embryonic stem cells at the request of President George W. Bush. A year later the president issued restrictions on federal funding for stem cell research on human embryos.  In 2005 and 2007, congress sent two different bi-partisan bills to Bush’s desk, which would overturn the public funding ban on stem cell research. However, each bill was vetoed and there weren’t enough votes to override the president’s decision.

In 2009, President Barrack Obama removed some funding restrictions on embryonic stem cell research with the executive order, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.” For the next four years, opponents of embryonic stem cell research took their case to court. In 2013, the Supreme Court upheld a lower court’s ruling in Sherley v. Sebelius, which dismissed a lawsuit against federal funding for embryonic stem cell research.

In December, just a month before leaving office, President Obama signed the 21st Century Cures Act. The bill includes $4.8 billion in funding to the NIH for the advancement of biomedical science, including regenerative treatments like stem cell therapy. The Cures Act does permit the FDA to accelerate the stem cell treatment approval process. However, supporters of Stem Cell treatments believe it doesn’t go far enough in making stem cell clinics fall within guidelines.

While the federal government has revised its policy on embryonic stem cell research, several states have created policies and programs that support stem cell research and other regenerative therapies. Many of these institutions were created in the wake of President Bush’s order to limit federal funding for embryonic stem cell research. With federal funding approved in 2009, as well as more potential money from the Cures Act, state lawmakers may question how much state money allocates to these institutions.

State Initiatives

Map of the United States

California—The California Institute for Regenerative Medicine

In 2004, California voters approved the California Stem Cell Research and Cures, which gave nearly $3 billion dollars over ten years to stem cell research clinics. The bill was a result of the federal government’s attempt to limit funding for stem cell research, while also showcasing California’s aim to become a hub for medical research. Proposition 71 helped create the California Institute for Regenerative Medicine, which was supported by 59 percent of the electorate in 2004. Thirteen years later, CIRM has elicited mixed public opinion. While proponents point to several cases where CIRM research has directly saved lives, opponents cite a lack of progress in comparison to NIH stem cell trials (while President Bush’s restrictions targeted embryonic stem cell research, the NIH continued to fund trials in 2006). In a 10-year span, NIH fully or partly funded 571 trials with $13.4 billion. Conversely, CIRM funded 50 trials with $2.2 billion. Opponents also site a lack of oversight, as well as a focus on infrastructure investment compared to research trials. In 2020, the CIRM will run out of money and it’s unclear whether they will ask voters for public financing, or seek funding through foundations or donations.

Connecticut—Connecticut Stem Cell Research Program

In 2005, state lawmakers provided $100 million in funding for stem-cell research projects over a 10-year period. In October 2014, the Connecticut Department of Health transferred its Stem cell research program to Connecticut Innovations, the state’s venture capital fund that matches public and private partnerships. Under Connecticut Innovations, the Stem Cell Research Program changed its name to the Regenerative Medicine Research Fund. They have collaborated with Yale, UConn and other private entities throughout the region.

Maryland—Maryland Technology Development Corporation

Republican Governor Robert Ehrlich signed the Stem Cell Research Act in 2006, which helped create the Maryland Stem Cell Research Fund. Similar to Connecticut, the fund aims to provide grants and loans to private and public clinics performing stem cell research. While the Maryland Technological Development Corporation (TEDCO) administers the funds, the Maryland Stem Cell Research Commission Fund, an independent scientific peer review committee, directs funding. Since 2006, more than $130 million and 375 research grants have been committed. In May 2016, TEDCO approved the commission’s recommendation for 26 new proposals, totaling more than $8.4 million. In February, MSCRF—along with John Hopkins Medicine and BioCardia, Inc.—announced a patient suffering from a debilitating heart condition had moved into the final trial stage of treatment following stem cell treatment.

Minnesota—Regenerative Medicine Minnesota

In 2014, the Minnesota State Legislature approved a bill that allocates $50 million over a 10-year period to support regenerative medical research. The state also wants leverage the economic potential of regenerative medicine, and created a funding category titled “Bio-business Development.” In 2016, RMM has issued $1.17 million in bio-business grants. The fund also supports research, patient care and education.

New Jersey—Stem Cell Institute of New Jersey

In 2007, voters rejected a proposal to fund a $450 million bond referendum to support stem cell research in the Garden State. Although the constituency had rejected the proposal, the assembly had already authorized the state to borrow up $270 million to cover construction costs for five stem cell labs across the state. When voters went to the poll to reject the initiative, the state had already incurred more than $2 million in planning expenses and broke ground. Nonetheless, Governor John Corzine (D) pledged to continue with the plan, but he put the project on hold six months later. In 2014, the Human Genetics Institute of New Jersey launched their own Stem Cell Program, which was labeled as the institute’s successor.

New York—The New York State Stem Cell Science

The New York Stem Cell Science Program (NYSTEM) launched in 2007 after the lawmakers approved an 11-year, $600 million investment in stem cell research. Since 2007, NYSTEM has issued 24 requests for applications, and made 323 awards totaling $354 million to 35 different institutions. The NYSTEM program aims to further the agenda of the Empire State Stem Cell Board, which serves as an accelerator for scientific knowledge about stem cell biology. In January 2015, Governor Andrew Cuomo (D) announced a $36 million grant for three stem cell research groups. More than $15 million of that grant was earmarked for Weill Cornell Medical College to help develop a cure for Sickle-Cell Anemia by using patients’ own stem cells.

Ohio—The National Center for Regenerative Medicine

Formed in 2003 through funding from an Ohio economic agency, the National Center for Regenerative Medicine includes partnership among Case Western Reserve University, The Cleveland Clinic, University Hospitals Case Medical Center and the Ohio State University. The NCRM focuses on regenerative medicine and stem cell research, cellular manufacturing and clinical trials for cellular therapeutics. In additions, the NCRM has focused on heart disease, cancer, genetic disorders, neurodegernative disease using non-embryonic stem cells. Ultimately, the center aims to use its research to help replace diseased tissues and organs.

Texas—The Institute for Regenerative Medicine at Texas A&M

Established in 2008, the Texas A&M Institute for Regenerative Medicine is a joint venture between Baylor University, Baylor Scott & White Hospital, and the Temple Bioscience District. With funding from the NIH, as well as Texas’s Emerging Tech Fund, the Texas IRM facilitates collaboration between scientists and Central Texas clinicians in an effort to create therapies for degenerative therapies. The IRM also provides human adult stem cells, rat stem cells, and mouse stem cells to academic researchers worldwide.

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