The first paralyzed patient in the western United States to get an injection of embryonic stem cells underwent treatment at Santa Clara Valley Medical Center Saturday (Sept. 17), according to a statement by Stanford University School of Medicine.
The medical centers have enrolled the fourth participant in the nation's first trial of stem cells derived from human embryos. The FDA-approved trial is meant to test the safety of injecting the cells in up to 10 people with recent spinal-cord injuries at seven trial sites across the United States. The trial is not intended to treat the patient's paralysis.
The patient was transferred from Kaiser Permanente and was treated at the Rehabilitation Trauma Center at Santa Clara Valley with cells prepared for injection at Stanford.
Stanford neurosurgeon Gary Steinberg, M.D., implanted the cells. Three other patients have previously received the surgically delivered cells: two at the Shepherd Center in Atlanta beginning in October 2010, and one at Northwestern Memorial Hospital and the Rehabilitation Institute of Chicago in May 2011.
The Stanford/Santa Clara Valley patient is the first person to receive the therapy west of the Mississippi, Stanford researchers said.
"We are extremely excited to participate in this landmark clinical trial," said Steinberg, the principal investigator of the Stanford/Santa Clara Valley portion of the trial.
"It signifies a major advance in translating an innovative research discovery into clinical therapy. I believe it is critically important to encourage and take part in stem-cell trials like this, which represent a new era in the effort to restore function for patients with ... devastating neurologic disorders," he said.
Stephen McKenna, M.D., chief of the rehabilitation center at Santa Clara Valley, agreed.
"Although it's been an intensive commitment of resources, we understand the importance of advancing new therapies for patients," he said.
The trial is being run by Geron Corp. of Menlo Park, which developed and manufactures the cells being tested. In May, Geron received a $25 million grant from the California Institute for Regenerative Medicine to continue and extend the trial to include a greater proportion of spinal-cord injured patients.
"When the people of California voted in favor of Proposition 71, they did so with the hope of seeing stem-cell-based therapies for chronic disease and injuries. This first California patient to participate in Geron's landmark spinal cord injury trial is a major step toward fulfilling that hope," said Jonathan Thomas, chair of the California Institute of Regenerative Medicine governing board.
"We are proud to be providing funding for this first safety trial, which is a critical step toward making safe and effective stem-cell-based therapies available to patients."
Researchers at Geron collaborated with Hans Keirstead and his laboratory team at UC-Irvine to develop a way to coax human embryonic stem cells to become a mixture of cells that include oligodendrocyte precursors.
Oligodendrocytes are cells in the brain and the central nervous system that wrap nerve cells with an insulating material called myelin. This myelin sheath is necessary for the transmission of the electric signals along the spinal cord that trigger muscles to move, and relay the sense of touch and temperature.
Damage to this sheath caused by trauma is a common cause of paralysis, according to researchers.
Patients in the trial were injured in the 14 days prior to participating in the trial in a specific region of their thoracic spine -- an area roughly from the top of the shoulder blades to the bottom of the rib cage. The damage caused complete paraplegia, meaning that they have normal sensation or movement to the level of the hands, but not from the trunk to the toes.
During the procedure, Steinberg applied about 2 million of the special cells directly into the injured area of the patient's spinal cord.
"The patient is doing well," he said.
Following the surgery the patient entered an intensive inpatient rehabilitation program. Researchers will now monitor the patient for any adverse effects to confirm that the cells are safe for use in humans.
In June, Geron reported preliminary trial results on the first two patients at two meetings -- the 2011 International Conference on Spinal Cord Medicine and Rehabilitation and the 2011 Spine Symposium.
The results so far show no significant adverse effects experienced by either patient. If this phase-1 trial of 10 patients shows that the treatment is safe, future trials will be designed to determine whether the cells are able to improve participants' clinical symptoms, researchers said.
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