Geron, based in Menlo Park, Calif., developed and manufactured the cells. The phase-1 trial was implemented to test the safety of the stem cells in human patients. Although Geron has discontinued the trial, the company will continue to monitor the five patients who have received the cells for a total of 15 years and is actively looking for partners to "enable further development of its stem cell programs."
Gary Steinberg MD, PhD., the Bernard and Ronni Lacroute-William Randolph Hearst Professor in Neurosurgery and Neurosciences at Stanford, is the principal investigator of the Stanford/SCVMC portion of the trial, and implanted the cells in the patient at the Rehabilitation Trauma Center at SCVMC. The neurosurgeon said :
"The procedure went smoothly and the patient is doing extremely well ... Although the decision by Geron to discontinue the trial was disappointing, I am confident that stem cell science will continue to move forward as we and others work to translate promising laboratory findings into clinical benefits for patients."
The first patient in the trial was treated in Atlanta in Oct 2010, with the first patient treated at Stanford 17th Sept. All the patients have responded well to treatment and the implants have been tolerated. Geron discontinued the trial almost entirely on financial concerns and the need to focus on its new cancer treatments, rather than because of any clinical failures.
The spinal cord injury trial had researchers at Geron collaborating with Hans Keirstead, PhD, and his team at UC-Irvine to develop a way to persuade human embryonic stem cells to become a mixture of cells that includes oligodendrocyte precursors.
Oligodendrocytes are cells in the brain and the central nervous system that wrap nerve cells with an insulating material called myelin. As any biology student will tell you, this myelin sheath is necessary for the transmission of the electric signals along the spinal cord that trigger muscles to move, and relay our sense of touch and temperature. Much like damage to the insulation on an electrical cable causing short circuits and loss of power, damage to this sheath, caused by trauma is a common cause of paralysis.
The trial was limited to patients who had been injured within 14 days and had only non-penetrating damage to a specific region of their thoracic spine. (upper part from lower ribs to shoulder). The damage needed to have caused complete paraplegia, meaning that the patients had normal sensation or movement to the level of the hands, but not the lower body or legs.
In this most recent procedure, Dr. Steinberg applied about 2 million of the special cells, called GRNOPC1, directly into the injured area of the patient's spinal cord. The patient then entered an intensive inpatient rehabilitation program under the supervision of spinal cord injury expert Stephen McKenna, MD, director of the Rehabilitation Trauma Center at SCVMC.
McKenna concluded :
"The future for stem cell research is bright ... Conducting the world's first clinical trial of human embryonic stem cells and showing that they have been safe is a historic milestone in this new and developing field. We are extremely proud of our accomplishment."
Written By Rupert Shepherd