Spinal Cord Injury: Progress, Promise, and Priorities

Emphasize and Coordinate Translational Multidisciplinary Research and Clinical Trials

Facilitate Clinical Trials (Recommendation 6.1)

Mechanisms should be implemented that will facilitate the implementation of clinical trials while observing the established standards for the protection of human subjects in clinical research, including:

coordinating existing facilities and resources in acute care, chronic care, and rehabilitation to support multicenter clinical trials,
utilizing central institutional review board mechanisms,
coordinating and expanding patient registries and databases to improve mechanisms to conduct clinical trials and facilitate patient recruitment,
developing a set of standardized clinical outcome measures, and
designing clinical trials that are a multidisciplinary effort and should incorporate, as appropriate, small “n” methodologies for early-phase clinical trials.

Increase Industry Involvement (Recommendation 6.2)

Mechanisms should be explored that can be used to link federal, state, academic, and nonprofit efforts with those of industry with the goal of increasing the investment and involvement of the private sector in the development of therapeutic interventions for spinal cord injuries.

Strengthen the Research Infrastructure and Enhance Training

Establish Spinal Cord Injury Research Centers of Excellence (Recommendation 7.2)

The National Institutes of Health should designate and support five to seven Spinal Cord Injury Research Centers of Excellence with adequate resources to sustain multidisciplinary basic, translational, and clinical research on spinal cord injuries.

Establish a National Spinal Cord Injury Research Network (Recommendation 7.3)

The National Institutes of Health should be appropriately funded to establish a National Spinal Cord Injury Research Network that would coordinate and support the work of an expanded cadre of researchers.

Increase Training and Career Development Opportunities (Recommendation 7.4)

Resources should be designated to strengthen education programs for pre-and postdoctoral training in spinal cord injury research.

The National Institutes of Health Office of Science Education and the National Institute of Neurological Disorders and Stroke should enhance training and develop a training module on the functional complexity of the spinal cord for neuroscience Ph.D. and medical students.

Table of Contents

Front Matter R1-R16

Executive Summary 1-12

1 Introduction 13-29

2 Progression of Spinal Cord Injury 30-63

3 Tools for Assessing Spinal Cord Injury and Repair 64-94

4 Current Therapeutic Interventions 95-120

5 Progress Toward Neuronal Repair and Regeneration 121-151

6 Developing New Therapeutic Interventions: From the Laboratory to the Clinic 152-182

7 Research Organization: Creating an Environment to Accelerate Progress 183-204

8 State Programs in Spinal Cord Injury 205-242

Appendix A Study Process 243-248

Appendix B Acronyms 249-251

Appendix C Glossary of Major Terms 252-259

Appendix D Tools to Assess Spinal Cord Injury Outcomes 260-267

Appendix E Clinical Trials of Methylprednisolone 268-274

Appendix F Examples of Alternative Therapies 275-277

Appendix G Spinal Cord Injury Clinical Trials Published from 1998 to 2003 278-319

Appendix H Legislation Sponsoring State Spinal Cord Injury Research 320-322

Appendix I Committee and Staff Biographies 323-332

Index 333-344