U.S. biotechnology company Geron Corp. has been given approval to begin the first-ever study of the effect of stem-cell injections on people who are paraplegic. More than 450,000 people live with a spinal cord injury in the United States alone, and an SCI is sustained by about 11,000 in the U.S. annually.
Eight to 10 participants with paralysis from the waist down will be injected with cells created from embryonic cells. (Because the single injection will be administered within two weeks of a spinal cord injury, the participants have not yet been selected.)
Goals is to Assess Drug Safety for Paralysis Patients
The U.S. Food and Drug Administration’s approval of Geron’s Investigational New Drug (IND) application will enable the company to undertake a human embryonic stem cell (hESC)-based therapy with participants, the first-ever trial of this kind. The goal of the clinical trial will be to determine the safety of Geron’s GRNOPC1 drug for patients who have sustained a “complete” grade A subacute thoracic spinal cord injury, as specified by the American Spinal Injury Association impairment scale. In other words, participants will be paraplegic, able to use their arms but not to walk.
Stem Cells Seen as Critical to Spinal Cord Injury (SCI) Research
For years the subject of fierce debate among scientists, doctors, politicians, and the religious community, embryonic stem cell research has long been seen as critical to finding ways to help damaged spines regenerate cells and heal themselves.
Notes, Dr. Glen House, co-founder of Disaboom.com and himself a paraplegic, “This is the news we’ve been waiting for, and the world will be watching with great anticipation and hope. We may someday look back on this study as the genesis of a cure for not just SCI, but also for other types of neurological impairments."
Research Focus: Safety, Repair of SCI Damage
The focus of the study will be twofold: first, to establish that GRNOPC1 is safe for spinal cord injury patients, and second, to see if injected stem cells will “grow up” into cells able to repair insulation surrounding damaged nerves and also assist those nerves to function and grow. This research is widely considered to be the first step in much greater applications of stem cells for addressing SCI damage.
To learn more about spinal cord injury (SCI):
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For more information about possible treatments for paralysis in SCI patients, see Potential Treatment for Paralysis?
For more information on maintaining your independence with an SCI, see Regular Exercise Helps SCI Patients Gain Independence.