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The Intrathecal Infusion of Mesenchymal Stem Cells into Healthy Rabbits is Safe and Devoid of Neurological or Clinical Complications

Minguell JJ, Pereira A, Bartholomew P and Lasala GP

Background: Cellular, molecular and transplantation studies using mouse and rat models of neurological diseases have revealed that Mesenchymal Stem Cells (MSC) represent a reliable candidate for cellular therapies for neurological conditions, including Amyotrophic Lateral Sclerosis (ALS) and Spinal Cord Injury (SCI). However, evaluation of safety aspects associated with route and dose of cell infusion, pivotal issues in cell therapy, has not been tested in large animals. Methods: This study was performed to evaluate whether the intrathecal infusion, by lumbar puncture (LP), of ex vivo-expanded MSC to healthy rabbits is a safe and feasible procedure. After infusion of the cell or placebo solution, clinical, neurological, behavioral and histopathological assessments were performed during five weeks. At the end of the follow up period, animals were sacrificed, autopsied and tissues prepared for histological examination. Results and Conclusions: The results of this preclinical study showed that the intrathecal infusion of MSC can be readily performed under safe and feasible conditions. These findings and the observation that procedural security is independent of cell dose (0.3-0.6 x 106 cells/kg rabbit body weight), give additional safety support to the notion that ex vivo expanded MSC can be employed in clinical settings intended to treat neurological patients.