Today Menlo Park, Calif-based Geron, Inc announced that they are discontinuing their stem cell programs, including the trial CIRM has supported testing an embryonic stem cell product for spinal cord injury.
In May, 2011 CIRM announced a $25 million loan to Geron to support their spinal cord injury trial, which was the first trial of cells derived from embryonic stem cells. Geron had received $6.42 million of their loan, which the company today repaid in full with accrued interest. The company says they are seeking partners to continue its stem cell programs.
As the first group to receive Food and Drug Administration approval to test human embryonic-derived stem cells in humans, Geron pioneered the regulatory pathway that other groups can learn from.
“We are optimistic about many exciting stem cell programs in California and internationally that have the potential to treat chronic diseases and conditions and that will benefit from the regulatory path first forged by Geron,” said Ellen Feigal, Senior Vice President for Research and Development. “Taking research through all the steps needed to get into clinical trials, then through the trials and into the clinic is a highly complicated process with many stops and starts along the way. CIRM plays a critical role in ensuring funding for these early-stage trials, which often have difficulty obtaining funding from other sources.”
In the initial stages of Geron’s trial, the goal was to find out whether the cells were safe before increasing the dose and assessing whether the cells were effective in treating people with spinal cord injury. The company has reported that the people who enrolled in the trial tolerated the therapy well and had no serious adverse effects after receiving the cells. Geron will continue to closely monitor those patients.
Roman Reed, who received a spinal cord injury in a 1994 football accident, said he remained hopeful that another company would partner with Geron and continue the trial. “On one level I am immediately disappointed with Geron’s decision to cease future enrollment of this important trial,” said Reed, who is also the namesake of the Roman Reed Spinal Cord Research Act which supports spinal cord injury research in California. “Still, there have been no serious adverse effects so we just need to find a new corporate partner for this venture because it’s still tremendously promising research with sound stem cell science that must be fully fiscally backed to go from bench to bedside.”
About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities.