NCT01254539

Trial name or title	Clinical trial on the use of autologous bone marrow stem cells in amyotrophic lateral sclerosis (extension CMN/ELA)
Methods	Randomised, double‐blind study
Participants	Inclusion criteria Diagnosis established using the World Federation of Neurology criteria More than 6 and less than 36 months of evolution of the disease Bulbar onset Over 18 and under 70 years old FVC ≥ 50% Total time of oxygen saturation < 90% inferior to 5% of the sleeping time Signed informed consent Exclusion criteria Neurological or psychiatric disease Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube Concomitant systemic disease Treatment with corticosteroids, immunoglobulins or immunosuppressors in the last 12 months Inclusion in other clinical trials Inability to understand informed consent
Interventions	Treatment arms Autologous bone marrow stem cells intraspinal transplantation at T3‐T4 Intrathecal infusion of autologous bone marrow stem cells Intrathecal infusion of placebo (saline solution) Cell dose not mentioned.
Outcomes	Primary outcome measures FVC Secondary outcome measures Neurological variables: ALSFRS, MRC and Norris scales Absence of adverse events Neurophysiological variables: electromyography, polysomnography, evoked potentials Neuroradiological variables: spinal magnetic resonance imaging (MRI) Respiratory variables: maximal inspiratory pressure, maximal expiratory pressure (PEM), sniff nasal, oxymetry Psychological variables: Health Questionnaire (EuroQol‐5D), Profile of Mood States (POMS)
Starting date	October 2010 (duration: 62 months)
Contact information	Moraleda Jiménez JM, Hospital Universitario Virgen de la Arrixaca
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