description of the Facilities of Research Excellence in Spinal Cord Injury [FOR-SCI] in Chapter 6). Replication studies are necessary to translate the findings from basic research into clinical practice, but they are rarely done because researchers in all scientific fields are rewarded for innovation, not replication.

The project also sponsors or participates in clinical trials, including clinical trials of drugs and rehabilitation devices. The project maintains a database with information on more than 2,000 chronically injured individuals who wish to participate in clinical research. This is easily accomplished because the university’s hospital is a regional trauma center that treats approximately 100 cases of acute spinal cord injury per year.

The Miami Project to Cure Paralysis also has a fertility program that has helped nearly 75 men with spinal cord injuries father children. It is one of two institutions in North America that collects spinal cord tissue from individuals with spinal cord injuries. It has amassed a bank with more than 200 samples from individuals with spinal cord injuries that researchers and clinicians use to investigate the etiology, mechanisms of complications, and potential avenues of treatment.

Recently, the project has begun to work with the Food and Drug Administration (FDA) to explore the process of obtaining approval for combination therapeutic interventions involving several drugs or other modes of therapeutic intervention. Investigators have found that the drug rolipram, a type IV-specific phosphodiesterase inhibitor that has FDA approval for use for another indication, is neuroprotective and growth promoting because it prevents cyclic AMP hydrolysis. When rolipram and additional cyclic AMP are combined with Schwann cell grafts, they promote axonal growth in an animal model of spinal cord injury (Pearse et al., 2004). Combination therapies, particularly those that combine cell-based therapies with drugs, will have far more complex regulatory requirements than single therapeutic approaches.

An external advisory committee evaluates the Miami Project to Cure Paralysis every 3 to 4 years. This form of evaluation is supplemented by the standard peer-review process involved in obtaining NIH grants.

California

History and Role of State Funding

In 2000, California Governor Gray Davis signed The Roman Reed Spinal Cord Injury Research Act of 1999, which is devoted to finding treatments for spinal cord injuries. The Act is named for Roman Reed, who sustained a spinal cord injury while playing college football. Reed’s family, along with many others, pressed for the legislation under the auspices of



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