Physicians injected the first-ever patient with millions of stem cells derived from human embryos in a clinical trial aimed at proving the treatment is safe for people with spinal cord injuries.
The trial, sponsored by Geron Corp. (NSDQ:GERN), calls for patients to receive the injection within 14 days of the injury. Geron said the main objective of the study is to assess how well patients tolerate the treatment. Later phases of the trial will examine whether the treatment is effective, according to a press release.
Geron president and CEO Dr. Thomas Okarma called the trial a “milestone for the field of human embryonic stem cell-based therapies.”
The trial’s results will be the subject of great scrutiny by proponents and opponents of embryonic stem cell research. The issue made worldwide headlines this summer after a federal judge barred federal funding of research using stem cell lines derived from embryos. A three-judge panel on a federal appeals court later overturned the ban, pending an appeal by President Barack Obama’s administration.
“There’s a lot of angst around these trials,” Evan Snyder, director of Sanford-Burnham Medical Research Institute’s stem cell program in San Diego, told the Washington Post. “There’s going to be this perception that if the cells do not perform well, the entire field will be illegitimate.”
Results of survey published last week by Harris Interactive/HealthDay showed that nearly three-quarters of adults polled believe scientists should be able to use stem cell lines culled from un-needed embryos from in vitro fertilization procedures.
Seventy-three percent of respondents said they believe stem cell research should be allowed “as long as the parents of the embryo give their permission, and the embryo would otherwise be destroyed,” according to the poll, which was notable in that a majority of Republicans, Catholics and born-again Christians also indicated their approval of the research.
“Two-thirds of the respondents agreed that, ‘If most scientists believe that stem cell research will greatly increase our ability to prevent or treat serious diseases we should trust them and let them do it,'” according to the survey.
In August, Judge Royce Lamberth of the U.S. District Court for the District of Columbia had ruled that federal funds could not be used for the the research, derailing scores of projects looking into the causes of diseases like Parkinson’s, Alzheimer’s and cystic fibrosis. Obama had sought to restore stem cell research funding from constraints imposed under the Bush administration, but Lamberth ruled that the policy violated the Dickey-Wicker Amendment, aimed at stopping the destruction of human embryos.
But Dickey-Wicker proved to be a sticky wicket for both plaintiffs and defendants when the appeals court issued a temporary stay of the Lamberth ruling.
Obama’s policy allowed the use of stem cell lines derived from frozen embryos from fertility treatments that were no longer needed and donated according to stringent ethical guidelines. The plaintiffs in the lawsuit, James Sherley and Theresa Deisher, argued that the Obama policy violated the Dickey-Wicker rules.
