Research Library

Regenerative medicine and stem cell research are exciting new fields. But as the fields progress toward clinical therapies, controversies emerge. Hype surrounding stem cell research has caused an increase in their use in interventions that are not clinically proven. Furthermore, the regulatory agencies have a lot of difficulty dealing with cell therapies, which are distinctly different from drugs and medical devices they more commonly approve. To move the field forward, advocates, regulators and scientists need to come together to find new options for stem cell research oversight that protects both the patients and the research field.

This report describes the problems associated with unproven stem cell treatments, focusing on those without FDA approval undertaken by NFL players in the past five years.

Biotechnology scientists must be aware of the broad patent landscape and push for new patent and licensing guidelines, according to a new paper from the Baker Institute.

In a recent commentary, Baker Institute science and technology policy experts described two international court cases that aimed to define “research” — and that ultimately arrived at two different answers. “What makes this interesting is that the courts’ definition of ‘research’ was based on politics — what the court wanted the end result to be,” said Kirstin Matthews, the institute’s fellow in science and technology policy. To reach a decision prohibiting human embryonic stem cell (hESC) patents, the EU court ruled that “research” occurs in a continuum. To reach a decision supporting federal funding of stem cell research, the U.S. court ruled that “research” involves a specific project.

Despite the political nature of stem cell research, this area of science continues to flourish in the United States. In 2011, the NIH funded approximately US$1.2 billion in stem cell research — a steady increase from past years — with US$123 million devoted to human embryonic stem cells. According to the ISI Web of Science, more than 4,000 U.S.-authored stem cell publications were produced in 2011, accounting for approximately 38 percent of the world total. Approximately one-quarter of these publications were collaborations with authors from other countries.

An overview of stem cell research and the policies, particularly in the state of Texas, that regulate these studies.

In this article, the authors compare two different approaches to establishing stem cell policy: a defined policy (U.K.) and a changing policy (U.S.). The U.K. has a clear and precise policy, agreed upon and supported by lawmakers, scientists and the public. By contrast, U.S. federal policy is continuously being updated based on balancing political ideologies and advances in science, and it only regulates federal funding. By investigating these contrasting policy approaches, the authors hope to demonstrate the impact of policy on stem cell research and public opinion.

A conference report for the "Stem Cells: Saving Lives or Crossing Lines" Texas-U.K. collaboration event.