July 23, 2005, is a day that Kelly Dean will not soon forget. The active young sculptor dove into the ocean on a visit to the beach, and accidentally struck a sandbar. With a fracture at C5 of her spinal cord, she was diagnosed as quadriplegic. Her family was told she would never walk again.

Dean’s care began immediately with surgery, after which she was assigned a physical therapist, a member of the hospital floor who worked extensively with Dean using rehabilitation techniques that would not aggravate her fragile, post-surgical condition. When Dean finally arrived at the Outpatient Rehabilitation Services Center of Good Samaritan Hospital Medical Center in West Islip, N.Y., after spending the intermittent weeks in a rehabilitation facility, she had already begun to make impressive progress.

“She came to us and was already walking, because the surgery had gone so well,” says Jack Sharpe, MS, OTR/L, an occupational therapist who worked with Dean. But, in spite of the progress Dean had already made, she faced many challenges ahead of her.

“She was very unbalanced with her upper extremities,” says Sharpe, who worked largely with Dean’s upper body issues. This was particularly important to Dean, since her art involved sculpting wood, an activity that requires a tremendous amount of fine motor control. “We tried to hone in on where she needed help; she really wanted to get back to where she was before,” Sharpe says.



Nonetheless, simple desire was not going to return Dean to sculpting overnight. “That wasn’t going to happen right away,” says Sharpe. He notes that his therapy started with simple tasks of daily living, like buttoning a button, zipping a zipper, washing her hair, and putting her hair in a ponytail. The last was very important to Dean, so Sharpe called upon his knowledge of the variety of component skills required, then devised therapeutic ways of addressing these.

He helped Dean work to develop flexion and strength in her shoulders, elbows, and wrists. He taught her to use biofeedback to help with some of her issues. And, of course, he included functional kinds of therapy, as she continually attempted to ponytail her hair.

Working with Dean was a challenge and an educational opportunity for Sharpe, as his facility does not typically work with patients with spinal cord injuries. “We don’t really see spinal cord injury patients, so someone with a C5 fracture who is now walking is uncharted territory,” he says. So Sharpe took this opportunity to educate himself. “My background is mostly hand therapy,” he says. “I was reading textbooks about how nerves heal.”

However, he had an easy time deciding how aggressively he could pursue Dean’s therapy. “Kelly is easy to work with and very grounded,” he says. “We told her, ‘We don’t know what you’ll get back,’ and she said, ‘Whatever it is, let’s try it.’” This made constructing a therapy plan easy. “We’re just going to push her as much as we can, as long as she’s up for it,” Sharpe says.

The persistence has paid off. Today, Dean walks unassisted, although she carries a cane occasionally for security. And this success has taught Sharpe some lessons he shares with other therapists: “You can’t be afraid to jump in. You always have to be open to trying different things,” he says, adding, “always take your cues from the patient.”

Understanding Spinal Cord Injury

The Rockville, Md.-based National Spinal Cord Injury Association (NSCIA), using statistics gathered at the University of Alabama at Birmingham, reports that each year in the U.S., there are 32 spinal cord injuries per 1 million people, or just less than 8,000 total each year. Currently, there are between 250,000 and 400,000 people living with spinal cord injury. This population is overwhelmingly male, at 82 percent of the number of spinal cord injuries, with the average age at injury being just over 33 years. Motor vehicle accidents are the most common causes (44 percent), followed by acts of violence (24 percent), and falls (22 percent). After the age of 45, falls overtake motor vehicle accidents as the leading cause of injury.

Those who work with spinal cord injury patients know the public has certain misconceptions about the condition. For one, a person can “break their back” – damage their vertebrae – and not sustain a spinal cord injury. For another, most people with spinal cord injury have not actually experienced a severing of the spinal cord; in most cases, the spinal cord remains intact, but there is damage that leads to loss of functioning.

Spinal cord injuries are classified by the vertebra level of the injury (ranging, from head to tailbone: cervical, thoracic, lumbar, and sacral), and whether or not the injury is complete – that is, whether or not there is a complete lack of function and sensation below the level of the injury. So, an incomplete injury at C5 means that the patient was injured at the level of the fifth cervical vertebra but retains some sensation and function below that level.

Cervical injuries typically result in quadriplegia, with injuries above C4 often resulting in the patient’s use of a ventilator to breathe. At C5 – Dean’s level of injury – there is often control in the shoulder and biceps, but no control at the wrist or hand. Thoracic injuries often result in poor trunk control due to lack of abdominal muscle control. Lumbar and sacral injuries may involve problems with control of the hip flexors and legs.

Searching for a Cure

Although there is no cure for spinal cord injury, NSCIA comments that there are several therapies that show some promise. Steroid therapy, such as methylprednisolone, can reduce the swelling that can occur from an injury, a common cause of secondary damage to the site. The NSCIA also notes that an experimental drug, Sygen – already used extensively in Europe and Mexico – has shown promise in reducing loss of function, although the mechanism of its operation is not understood.

More recently, at the end of January 2009, the U.S. FDA announced approval for a phase one trial of GRNOPC1, a therapeutic intervention from Menlo Park, Calif.-based Geron Corp. This therapy is derived from human embryonic stem cells for use in patients with acute spinal cord injury. The stem cells are derived from the line created before August 9, 2001, and therefore fall within the restrictions President George W. Bush placed on federal support. This study and product, however, have received no federal funding.

According to Geron president and CEO, Thomas Okarma, PhD, MD, “This marks the beginning of what is potentially a new chapter in medical therapeutics – one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord.”


This phase one trial will examine the safety of the drug, initially looking at patients with subacute, functionally complete injuries between T3 and T10. The study involves a single dose of the therapy, and the trial is open label. The study will also involve delivering injections to qualified patients between seven and 14 days after the injury, which is thought to be after the initial inflammatory stage, but before significant scarring. Although the objective of the study is to ascertain safety of the therapy, it will also look at efficacy. Patients will be followed for the year following the injection, and sensation and lower extremity motor capability will be assessed at a variety of points throughout the year.

“The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," says Richard Fessler, MD, PhD, professor of neurological surgery at the Chicago-based Feinberg School of Medicine at Northwestern University. “Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.”

Although it is early in the study process, there is reason for cautious optimism. Animal models showed that the drug produced significant improvement in locomotor activity and kinematic scores when the animals received the therapy seven days post-injury. These animal studies showed increased axonal survival, as well as externsive remyelination surrounding the axons nine months after injection. Most interestingly, the company reports that cells were shown to migrate and fill the lesion cavity. Additionally, the company reports that the oligodendrocytes produce nerve growth factors, and that it believes it will find this therapy to work, at least in part, by stimulation of nerve regrowth.

Regardless of the results of this or future trials, it is likely that patients with spinal cord injury will always benefit from the help of a competent, dedicated therapist. Whether it be a therapeutic trial or proven occupational or physical therapy, one can take a lesson from Dean and Sharpe, and never be afraid to try.
   
    –– Jennifer Patterson Lorenzetti is an Ohio-based freelance technology writer and the owner of Hilltop Communications. Questions and comments can be directed to editorial@therapytimes.com.