Indianapolis – It could be a major step forward for stem cell research and patients paralyzed with spinal cord injuries. An American biotech company is now poised to launch the world’s first study of a treatment based on human embryonic stem cells.
Sam Schmidt is beaming at the news. Advancing research for the paralyzed is what he’s lobbied for over the past eight years.
“It’s not like winning the Indy 500 but it’s pretty darn close,” said Schmidt.
The Indycar driver was paralyzed during a practice-lap crash in 2000. Eyewitness News caught up with him at his home in Las Vegas. Schmidt travels 120 days a year working for his Indy-based racing team and his paralysis foundation, which works in close alliance with the Christopher Reeve Foundation.
“Our motto as a foundation is racing to recovery, and it’s a race. It’s a race for me to be able to have something in my lifetime to try and when you look at the numbers there’s 700,000 people living in this country just like me,” said Schmidt.
With FDA approval, California-based Geron is moving forward with the world’s first safety study of a human embryonic stem cell based therapy in humans with eight to ten paralyzed patients with spinal cord injuries.
“What we actually expect to see is modest improvement in patients with so-called complete injuries who are paralyzed for life. Slight improvements in sensation, bladder control, locomotion could be amplified with physical therapy. So we’re trying to fit the frame shift outcome from one of no hope to one of progressive rehabilitation,” said Thomas Okarma, Geron Corp.CEO.
Under the Bush administration, stem cell research was slowed by an executive order signed in August 2001 that restricted the types of stem cells and stem cell research that could be conducted. President Barack Obama is widely expected to lift Bush’s executive order.
The use of embryonic stem cells is a divisive issue that raises questions for ethicists as well as researchers.
“We’re not sure what is going to happen when you stick them in a human being,” said Dr. Eric Meslin, IUPUI ethicist. “Now there have been some reports that stems cells, embryonic stem cells might cause little tumors to grow. You don’t want a tumor growing on a spinal cord for all the obvious reasons.”
Enrolled patients will receive a single injection within two weeks of their injury. Managing patient expectation is crucial to this study. They will take the risk of enrolling without knowing how they would do with therapies now available. Also, there are questions about whether this is the best application – why not test this for Parkinson’s patients, macular degeneration or diabetes? The world will closely watch how this trial proceeds. Geron
Anne Marie Tiernon/Eyewitness News