The State of Stem Cells, 2006

Hwang Woo-suk’s reputation, and the hopes of millions of disabled people, balanced precariously on the outcome of the investigation into his alleged cloning successes. Longing for a cure for paralysis, I held out a faint hope that Seoul National University’s final report, released Tuesday, would clear Hwang’s name and allow him to continue his research.

On the count of fabricating data about 11 tailor-made embryonic stem-cell lines in 2005: guilty. On the count of lying in 2004 about being the first scientist in the world to derive human cloned embryonic stem cells: guilty. On the count of failing to clone Snuppy: not guilty.

Snuppy’s authenticity offered little comfort. I winced as I read the report. The stings of betrayal were real, if not completely unexpected. This must be how Michael Jackson fans felt. Even with all evidence pointing to Hwang’s guilt, something inside me still wants to believe he’s innocent.

But, like a good investment manager, my portfolio is diverse. In the wake of Hwang’s spectacular fall from grace, I’ve gathered around me for comfort information about the treatments that have the best chance of reaching human clinical trials in 2006.

I met Kwaku Nantwi, an associate professor of anatomy at Wayne State University, at last year’s Society for Neuroscience annual conference, and we discussed his ongoing theophylline study. Nantwi said results from the trial should be available soon, and if they’re positive, the treatment would improve breathing ability in quadriplegics with high-level injuries like mine, which is at the third Cervical segment with some damage to the fourth. My ability to cough could be restored and my susceptibility to pneumonia reduced.

Pharmaceutical giant Novartis, building on University of Zurich professor Martin Schwab’s (.pdf) work, is starting human clinical trials for acute injuries this year, focusing on a protein in the Central Nervous System that prevents new nerve growth. In the uninjured spinal cord, a family of proteins called Nogo prevent random rewiring, which could lead to pain. In the injured spinal cord, however, the protein prevents regrowth and leaves people paralyzed. The Novartis study will focus on blocking one version of the protein called Nogo-A in freshly injured patients.

In March, BioAxone Therapeutic will complete an early-stage human trial of a drug called Cethrin, also focusing on acute injuries, with results due in June. If results are positive, the final phase of trials will commence at the end of the year.

Oh, to be young and freshly injured.

Despite the focus on recent injuries, chronically injured people like me (I sustained my injury nine years ago in a car accident) still have hope. Inhibiting Nogo should allow regrowth in long-term injuries as well. And Frank Bobe, president and CEO of BioAxone, said in an e-mail that if the drug works for acute injuries, “there are no reasons why Cethrin should not work in chronic patients if one can overcome additional barriers such as the collagen and glial scar.”

Yet another company, Total ReCord, is focusing on both acute and chronic injuries. Researchers there are developing a drug called RMx to prevent secondary damage and encourage Regeneration. The company is one study away from asking the Food and Drug Administration for approval to begin a human clinical trial. If Total ReCord can attract funding, this could be the sleeper therapy for paralysis in 2006.

Exercise is another promising treatment. How does someone who’s paralyzed exercise, you ask? Dr. John McDonald, a neurologist and director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute, has developed a program using Functional Electric Stimulation, which can induce muscles to, for example, push a bike pedal. McDonald was Christopher Reeve’s doctor, and the actor was participating in similar therapies before he died. McDonald is applying for more funding to complete a clinical trial he hopes will show that his program induces neural regeneration and, most importantly, Functional recovery.

Companies tend to focus on the newly injured because their muscles aren’t yet atrophied and the neural memory of how to move is still fresh. Therefore, these patients can see results faster. McDonald’s treatment could make chronic patients more physically fit and attractive to companies developing drugs.

These are just five of the many things I expect out of this year. Others to keep an eye on are potential human trials from Geron, Geoffrey Raisman and the China SCI Network. Carlos Lima is also expected to publish results from his nasal mucosa transplants soon. Legislatively, look for a renewed push of the Christopher Reeve Paralysis Act and an unnecessarily vicious debate on the Pluripotent Stem Cell Act.

In the end, I just hope my faith this year buys me more than a dog.

By Steven Edwards

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