FDA Approves First Human Embryonic Stem Cell-Based Clinical Trial

""It marks the dawn of a new era in medical therapeutics," Geron Chief Executive Thomas Okarma said. "It …reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of health replacement cells."

Researchers are eager to experiment on embryonic stem cells because stem cells are master cells that can turn into any tissue in the body with the embryonic stem cells being the strongest type. "These are living cells that will divide, make more of themselves and migrate throughout the lesion after injection," Okarma said.

The study is currently in Phase I of the trial, which is intended to test the safety of the treatment. Geron will be injecting the stem cells into people with spinal cord injuries within 7-14 days of the SCI with the hope that the cells can help repair the spinal cord and regenerate nerve cells. Evidence has shown this therapy may not work for older injuries.

Dr. Hans Keirstead’s lab [at UCI, which Life Rolls On has previously funded] was the first in the world to generate a high purity population of an adult cell type from human embryonic stem cells, rendering them useful for human treatment. He developed a method to make human embryonic stem cells become near-pure populations of oligodendrocyte, a spinal cord cell type lost after spinal cord injury. Replacement of the lost cells resulted in restoration of walking ability for paralyzed rats.

"This is an exciting first step for Geron and for spinal cord injured patients whose lives may improve due to advances in medical research," said Peter T. Wilderotter, president and chief executive of the Christopher & Dana Reeve Foundation. "There has been so much speculative and unsubstantiated information about the use of stem cells in spinal cord injury; it is important to study these cells in a rigorously designed clinical trial that is monitored by the F.D.A."

This will be the first human embryonic stem cell-based clinical trial in the world.

Citations

FDA OKs human stem cell therapy testing
Retrieved March 23, 2009

The Washington Post: U.S. OKs 1st stem cell test on people
Retrieved March 23, 2009

FDA Approves a Stem Cell Trial
Retrieved March 23, 2009

Spinal Cord Stem-Cell Trial Could Start Soon, Report Says
Retrieved November 12, 2008

US Stem Cell Research May Get Boost
Retrieved November 12, 2008

Studies Show Geron’s Stem Cell Therapeutic for Spinal Cord Injury Produces Nerve Growth Factors
Retrieved November 12, 2008

Obama Renews Support for Embryonic Stem Cell Research
Retrieved November 12, 2008