Stem cell transplantation in amyotrophic lateral sclerosis patients: methodological approach, safety, and feasibility.
Amyotrophic lateral sclerosis is characterized by the selective death of motor neurons. Stem cells have been proposed as a potential therapeutic strategy. The safety of stem cell transplantation into the frontal motor cortex to improve upper motor neuron function is described. Sixty-seven  patients with definite amyotrophic lateral sclerosis were included. After giving their informed consent, the patients underwent magnetic resonance imaging, functional rating, pulmonary function test, and laboratory tests. Their bone marrow was stimulated with daily filgrastim (300 µg)  given subcutaneously for 3 days. Peripheral blood mononuclear cells were obtained by leukapheresis. Isolated CD133(+) stem cells were suspended in 300 µl of the patient's cerebrospinal fluid and implanted into the motor cortex. Adverse events were recorded at each step of the  procedure and were classified according to the Common Terminology Criteria for Adverse Events v3.0. The survival at 1 year was 90% after transplantation. with a mean long-term survival rate of 40.17 months from diagnosis. The most common adverse events were in grades I-II and involved  transient skin pain (19.5% of patients) attributed to the insertion of the Mahurkar catheter into the subclavian vein, minor scalp pain (15.9%), and headache (12.2%) from the surgical procedure. Several patients (1.5 - 4.5%) reported diverse grade I adverse events. There were two deaths,  one considered to be associated with the procedure (1.5%) and the other associated with the disease. Autologous stem cell transplantation into the frontal motor cortex is safe and tolerated well by patients. Further controlled studies are required to define the efficacy of this procedure.
Neurology Service, Hospital San Jose Tec de Monterrey, Monterrey, Nuevo Leon, Mexico. drhectormtz@yahoo.com
Héctor R
HR
Martínez
Juan Francisco
JF
Molina-Lopez
María Teresa
MT
González-Garza
Jorge E
JE
Moreno-Cuevas
Enrique
E
Caro-Osorio
Alfonso
A
Gil-Valadez
Eugenio
E
Gutierrez-Jimenez
Oscar E
OE
Zazueta-Fierro
J Alfonso
JA
Meza
Patricio
P
Couret-Alcaraz
Martin
M
Hernandez-Torre
D000690:Amyotrophic Lateral Sclerosis / Q000097:blood / Q000134:cerebrospinal fluid / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007937:Leukapheresis / Q000379:methods; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D008875:Middle Aged; D009044:Motor Cortex / Q000601:surgery; D011994:Recombinant Proteins / Q000008:administration & dosage
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim