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 was excited to learn that the FDA has finally given the all-clear to test embryonic stem cells as a potential treatment for spinal cord injury.
Geron Corp. who has invested 15 years of research and over $150 million to develop the treatment, finally hopes to start human testing by year-end. The stem cell therapy known as GRNOPC1 contains cells called oligodendrocyte progenitor cells. Those progenitor cells turn into oligodendrocytes, a type of cell that produces myelin, a coating that allows impulses to move along nerves. When those cells are lost due to injury, paralysis can follow. If GRNOPC1 works, the progenitor cells will produce new oligodendrocytes in the injured area of the patient’s spine, potentially allowing for new movement.
The therapy will be injected into the patient’s spine 1-2 weeks after the patients suffer an injury between their third and tenth thoracic vertebrae, or roughly the middle to upper back. The company plans to enroll 8-10 patients across the U.S. Each patient will be studied for one year and monitored for a further 15 years. A successful outcome would lead to larger and longer studies of GRNOPC1. Later trials would include patients with less severe spinal injuries and damage to other parts of the spine
Doctors are euphoric. Professor Richard Fessler, MD, a neurological surgeon at Northwestern University says it may be possible to completely restore a patient’s motor functions. “It would be revolutionary. The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.”
While this study may come too late for many high profile campaigners, including “Superman” and a former first lady, it has the promise of being a step in the right direction.
In the words of Nancy Reagan, “Countless people suffering from many different diseases, stand to benefit from the answers stem cell research can provide. As I’ve said before, time is short and life is precious.”
Right or wrong? Word on Health looks forward to hearing from you.