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Objectives

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OBJECTIVES

After reading this chapter, the reader will be able to:

  • Outline the pathophysiology of spinal cord injury (SCI), identifying potential targets for neuroprotective and regenerative treatments

  • Describe priorities in SCI research

  • Describe past, present, and impending clinical trials and experimental procedures directed at neuroprotection, neural cell replacement, and axon repair

  • Discuss the rationale and preclinical experience for each intervention

  • Discuss the importance of scientific rigor for advancing the field of SCI research

  • Outline current issues important for the translation of preclinical procedures to clinical trials

  • Apply knowledge gained from this chapter to current clinical practice

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Introduction

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In recent decades, progress in the field of neurobiology has led to new knowledge suggesting that regeneration of the central nervous system (CNS) might be an attainable goal. Today, one of the greatest challenges faced by researchers is that of achieving functional repair of the injured spinal cord. Scientists have developed several transplantation strategies that promote axonal regrowth and partial recovery in experimental models of spinal cord injury (SCI). Because these preclinical experimental strategies demonstrate some extent of axonal regeneration, translating them into human clinical trials is expected in the not too distant future.

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Though several trials directed at promoting recovery after SCI have been carried out in humans over the years, an effective treatment has been elusive. Some studies have used pharmacological interventions, while others have included cellular transplantation approaches based on a variety of promising strategies that induced regeneration and functional improvements in experimental models of SCI. As new treatment strategies are designed and advanced to clinical trial, the prospect of recovering lost spinal cord functions seems tantalizingly close. Media reports and the Internet are revealing enticing news of possible functional improvements to the community of people with SCI. Some people are acting on the opportunity to undergo various experimental procedures that, in the opinion of some in the SCI scientific community, have not been subjected to valid clinical trials. An expectation that an effective treatment is imminent is presenting new challenges to health care professionals providing education and care to their clients.

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This chapter will examine several interventions recently subjected to clinical trial so readers can become more savvy consumers of the research literature related to SCI. Readers can also use the knowledge to help clients gauge their expectations of current clinical trials and decide if they will participate. Clinical trials of interventions for SCI have been abundant, with more than 300 peer-reviewed articles published between 1999 and 2003.1 Most of those trials were directed at chronic complications associated with SCI, such as bowel, bladder, and sexual problems; exercise; locomotion; and muscle spasticity and control. The focus of this chapter is on clinical trials that involve pharmacological or invasive experimental procedures and that have the goal of improving neurological recovery in people with SCI. Past, current, and impending clinical trial experiences documented in the scientific literature will be ...

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