INTRODUCTION: Recently it has been shown in animal models of amyotrophic lateral 
sclerosis (ALS) that stem cells significantly slow the progression of the 
disease and prolong survival. We have evaluated the feasibility and safety of a 
method of intraspinal cord implantation of autologous mesenchymal stem cells 
(MSCs) in a few well-monitored patients with ALS.
METHOD: Bone marrow collection was performed according to the standard procedure 
by aspiration from the posterior iliac crest. Ex vivo expansion of mesenchymal 
stem cells was induced according to Pittenger's protocol. The cells were 
suspended in 2 ml of autologous cerebrospinal fluid and transplanted into the 
spinal cord by a micrometric pump injector.
RESULTS: No patient manifested major adverse events such as respiratory failure 
or death. Minor adverse events were intercostal pain irradiation (4 patients) 
which was reversible after a mean period of three days after surgery, and leg 
sensory dysesthesia (5 patients) which was reversible after a mean period of six 
weeks after surgery. No modification of the spinal cord volume or other signs of 
abnormal cell proliferation were observed.
CONCLUSIONS: Our results appear to demonstrate that the procedures of ex vivo 
expansion of autologous mesenchymal stem cells and of transplantation into the 
spinal cord of humans are safe and well tolerated by ALS patients.