Dr. W. Dalton Dietrich, scientific director of the Miami Project to Cure Paralysis, was in Washington this week seeking U.S. Food and Drug Administration approval to start a clinical safety trial of a remarkable new therapy for those suffering from brain and spinal cord injuries.
The Miami Project was co-founded 26 years ago by neurosurgeon Barth Green and Hall of Fame middle linebacker Nick Buoniconti, who led the 1972 Miami Dolphins’ legendary No Name Defense — the only NFL team to win the Super Bowl after a perfect season.
In 1985, Buoniconti’s son, then a 19-year-old sophomore at the Citadel, severed his spinal cord during a college football game. Now 44 and president of the Miami Project, Marc Buoniconti is a quadriplegic who uses a motorized, breath-operated wheelchair to get around.
In addition to state and federal grants, the Buoniconti Fund has raised millions of private dollars for spinal cord research, and the Miami Project is now on the verge of making medical history.
Dr. Dietrich told The Washington Examiner that project scientists have successfully repaired central nervous system injuries in lab animals by transplanting their own adult Schwann cells — which insulate the peripheral nervous system — to the site of the injury, where they reinsulate damaged nerve cells. If approved by the FDA, the next step is a five-year safety study on human subjects.
Last May, the California Institute for Regenerative Medicine gave Geron Corp. a $25 million loan to conduct the first FDA-approved human clinical trial using embryonic stem cells to cure spinal cord injuries — research banned during the Bush administration, but allowed under President Obama.
Geron not only pioneered the use of embryonic stem cells, it also obtained “exclusive commercialization rights.” However, in November, Geron suddenly halted its clinical trial midway, abandoning 15 years of research and $150 million in investments.
Geron claimed its “financial priorities” had shifted and it wanted to focus exclusively on its cancer drugs. But Daniel Salomon, associate professor at the Scripps Research Institute’s Department of Molecular and Experimental Medicine, told ABC News:
“This company would not walk away from this trial in the absence of an unexpected complication or safety concern, if there was any evidence that it was working.”
Geron’s withdrawal left the field to the Miami Project. Dr. Dietrich believes that Schwann cell transplants will eventually be the gold standard in treating spinal cord injuries and other devastating conditions ranging from traumatic brain injury to stroke and Alzheimer’s.
Dr. Dietrich — who wrote the first groundbreaking paper in 1986 on medically induced hypothermia to treat cardiac arrest — also discovered that cooling is beneficial for spinal cord injuries as well because it reduces a pathological reaction he calls “suicidal cell death.”
And unlike embryonic cells, whose growth is “very hard to control,” initial testing shows no evidence of tumor formation from Schwann cell transplants.
“If ‘cure’ means being exactly what you were before, that’s pretty difficult,” Dr. Dietrich told us. “But animal models have shown that Schwann cells can improve function in walking, the ability to use upper extremities, and increase strength. These are quality-of-life issues.”
About 12,000 people suffer severe spinal cord injuries each year in America. “These are mostly young people, injured in sports, the military, or as victims of violence,” Dr. Dietrich said.
Restoring at least some function to damaged nerves, or even easing the untreatable neuropathic pain experienced by half of all paralyzed patients, was a pipe dream during the “Dark Ages” 25 years ago. “We’re very confident our approach is safe,” Dr. Dietrich added. “The science is there.”
And now, so is the hope.
Barbara F. Hollingsworth is The Examiner’s local opinion editor.