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Stem Cell Clinical Trials for Spinal Cord Injury: Readiness, Reluctance, Redefinition

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Abstract

A wealth of scientific and clinical research has focused on the use of stem cells as a potential therapy for spinal cord injury (SCI), culminating most recently in the initiation of clinical trials. However, with the urgency that scientists and clinicians have undertaken to move forward with novel therapies for this devastating injury, the perspectives of stakeholders who live with a SCI have been left behind. Translational research in this rapidly growing field therefore overlooks a critically important viewpoint. We address this concern with a qualitative study of the perspectives on experimental stem cell treatments from individuals who have actually suffered a spinal cord injury. Using focus groups and interviews, we engaged individuals with thoracic and cervical SCIs at sub-acute and chronic stages post-injury. We found four major themes that inform the progression of stem cell research to clinical trials: ‘readiness’, ‘the here and now’, ‘wait and see’, and ‘informed hope’. Taken together, the data suggest a profound difference related to target timing of stem cell clinical trials and the perspectives about timing from those who are the end-beneficiaries of therapy. To bridge this gap, we conclude with a number of considerations for the timing disparity of trials and recommendations for improving informed consent.

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Acknowledgements

This research was supported by the Stem Cell Network—Networks of Centres of Excellence (NCE)/Research 9/5251(CT8) (F. Miller, P.I.), CIHR CNE #85117 (J.I.) and the US-Canada Fulbright Program. B.K.K. is supported by Career Salary Awards from the Michael Smith Foundation for Health Research and CIHR. Many thanks to Leilani Reichl and Allan Aludino, Spine Research Centre, Blusson Spinal Cord Centre for assistance with the recruitment of participants, and the participants who gave us their time and trust. We are also grateful to Michelle Sharp of Edge Consulting for facilitating the focus groups and assisting with the analysis of the data, to Sara Parke and Ania Mizgalewicz for their analysis work and manuscript preparation, and to Dr. Marleen Eijkholt for valuable discussions about the work. Finally, we thank the reviewers for their insights and constructive comments.

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Authors and Affiliations

  1. Division of Neurology, Department of Medicine, National Core for Neuroethics, University of British Columbia, 2211 Wesbrook Mall Koerner Pavilion, Room S124, Vancouver, BC, V6T 2B5, Canada

    J. Illes

  2. National Core for Neuroethics, University of British Columbia, 2211 Wesbrook Mall Koerner Pavilion, Room S124, Vancouver, BC, V6T 2B5, Canada

    J. C. Reimer

  3. Department of Orthopaedics, Combined Neurosurgical and Orthopaedic Spine Program, University of British Columbia, Vancouver, Canada

    B. K. Kwon

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  1. J. Illes
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Correspondence to J. Illes.

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Illes, J., Reimer, J.C. & Kwon, B.K. Stem Cell Clinical Trials for Spinal Cord Injury: Readiness, Reluctance, Redefinition. Stem Cell Rev and Rep 7, 997–1005 (2011). https://doi.org/10.1007/s12015-011-9259-1

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