Scientists See Progress in FDA Stem Cell Trial Approval

  • 6 January, 2009

ISSCR Cautions Clinical Research Still at an Early Stage

Deerfield, IL, January 26, 2009 – The International Society for Stem Cell Research (ISSCR) shares in the excitement generated by the U.S. Food and Drug Administration‘s landmark decision to approve the first clinical trials using the products of human embryonic stem cells, yet advises the public to maintain realistic expectations at this early stage.

A milestone for the clinical application of stem cell research, the FDA sanctioned Geron Corporation to begin trials on patients with acute spinal cord injury. The ISSCR reiterates that the Phase I trial will focus on assessing the safety of using these cells in patients, a first step of many in determining whether this treatment can provide therapeutic benefit. Regardless of outcome, the knowledge gained from the trial will provide valuable insight for future studies as researchers continue moving stem cell research into the clinic.

“The go-ahead to test products of embryonic stem cells in patients is an important first step, but only the first step on a very long journey, “ said George Q. Daley, immediate past-president of the ISSCR and associate director of the Stem Cell Program at Children’s Hospital Boston. “We have so much more to learn about stem cells, and this first trial is only the beginning. We applaud Geron’s hard work and diligence getting to this point.”

The approval comes after an extensive review process, which echoes the responsible, regulated and external evaluation procedures called for in the ISSCR Guidelines for the Clinical Translation of Stem Cells, released last month.

“This is a great time for stem cell science,” said David Scadden, co-chair of the ISSCR Clinical Translation Committee, director of the Massachusetts General Hospital Center for Regenerative Medicine, and co-director of the Harvard Stem Cell Institute. “The FDA has signaled that the safeguards are now in place to begin testing embryonic stem cell therapies. If the White House follows through with lifting restrictions on federal funding, we could see a great flowering of new research and an opportunity to see if these cells can deliver for patients.”

Note: In December 2008, the ISSCR released Guidelines for the Clinical Translation of Stem Cells for the responsible development of safe and effective stem cell therapies for patients. The Guidelines, a handbook for patients and more information can be found here.

The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.