Brain Advance Access originally published online on October 11, 2005
Brain 2005 128(12):2951-2960; doi:10.1093/brain/awh657
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Autologous olfactory ensheathing cell transplantation in human spinal cord injury
1 Eskitis Institute for Cell and Molecular Therapies, Griffith University, Brisbane, 2 Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, 3 Department of Otolaryngology, Head and Neck Surgery, 4 Department of Orthopaedic Surgery, 5 Department of Neurosurgery and 6 Spinal Injuries Unit, Queensland Spinal Cord Injuries Service, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia 7 Present address: Neurobiologie des Interactions Cellulaires et Neurophysiopathologie, CNRS UMR 6184, Faculté de Médecine, 27 Bd Jean Moulin, 13385 Marseille Cedex 05, France
Correspondence to: Dr Alan Mackay-Sim, Eskitis Institute for Cell and Molecular Therapies, Griffith University, Brisbane, Qld 4111, Australia E-mail: a.mackay-sim{at}griffith.edu.au
Olfactory ensheathing cells transplanted into the injured spinal cord in animals promote regeneration and remyelination of descending motor pathways through the site of injury and the return of motor functions. In a single-blind, Phase I clinical trial, we aimed to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the injured spinal cord in human paraplegia. Participants were three male paraplegics, 18–55 years of age, with stable, complete thoracic injuries 6–32 months previously, with stable spinal column, no implanted prostheses, and no syrinx. Olfactory ensheathing cells were grown and purified in vitro from nasal biopsies and injected into the region of damaged spinal cord. The trial design includes a matched injury group as a control for the assessors, who are blind to treatment status. Assessments, made before transplantation and at regular intervals subsequently, include MRI, medical, neurological and psychosocial assessments, and standard American Spinal Injury Association and Functional Independence Measure assessments. One year after cell implantation, there were no medical, surgical or other complications to indicate that the procedure is unsafe. There is no evidence of spinal cord damage nor of cyst, syrinx or tumour formation. There was no neuropathic pain reported by the participants, no change in psychosocial status and no evidence of deterioration in neurological status. Participants will be followed for 3 years to confirm long-term safety and to compare neurological, functional and psychosocial outcomes with the control group. We conclude transplantation of autologous olfactory ensheathing cells into the injured spinal cord is feasible and is safe up to one year post-implantation.
Key Words: human; transplantation; spinal cord injury; paraplegia
Abbreviations: ASIA = American Spinal Injury Association; GFAP = glial fibrillary acidic protein
Received August 24, 2005. Revised September 5, 2005. Accepted September 13, 2005.
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