Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis

Phase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.

The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective, single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical trial.

Inclusion Criteria:

• Diagnosis of definite or probable ALS according to the criteria established by the World Federation of Neurology
• Patient that provides reasonable assurance of adherence to protocol.
• Neurophysiological data confirming affectation of lower motor neurons in the lumbar region.
• Assessment of motor deficits in dorsiflexion of both feet (4 or 5 points on the MRC scale)
• The patient must fulfill all inclusion criteria.

Exclusion Criteria:

• Diabetes Mellitus.
• Other diseases that may present with polyneuropathy.
• Previous history of stroke.
• Prior Pathology of the peripheral nervous system affecting one or both lower limbs with or without clinically evident neurological sequelae.
• Pregnant or breastfeeding patients active.
• Patients physiologically capable of becoming pregnant, unless they are using reliable contraception.
• Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
• Positive serology for hepatitis B, hepatitis C or HIV.
• Clinical and anesthesiologic Criteria, contraindicating either sedation or extraction of MO (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin puncture site, etc.)
• Included in other clinical trials in the last 6 months.