Back in August 2010, Word on Health brought you news that the FDA had given the green light for a stem cell therapy trial.
Given the enormous ethical and regulatory hurdles surrounding this controversial topic, we take our hats off to Geron Corporation who, on Monday, announced the enrolment of the first patient.
The primary objective of the Phase I study is to assess the safety and tolerability of the stem-cell therapy GRNOPC1 in patients with recent thoracic spinal cord injuries. The therapy is injected directly into the injured area and is hoped to restore spinal-cord function by triggering the production of myelin-producing cells, potentially allowing for new movement.
Spinal Cord Injury is caused by trauma to the spinal cord that results in loss of functions such as movement, sensation and bowel or bladder control. Every year approximately 12,000 people in the U.S. sustain spinal cord injuries. The most common causes are automobile accidents, falls, gunshot wounds and sports injuries.
The initiation of this Phase I study is thought to represent the first publicly known use of embryonic stem cells in humans.
According to Geron’s President and CEO, Thomas B. Okarma, Ph.D., M.D. “Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies. When we started working on this in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials.”
In order to participate in the study, patients must be newly injured and receive the therapy within 14 days of the injury. The company has said it plans to enroll between eight and 10 patients in the US.
The trial is expected to take about two years to complete. Word on Health will be watching closely and will bring you further news as it breaks. In the meantime we’d love to hear from you about your thoughts on this.
SRxA's Word on Health 