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.
Lead SponsorRed de Terapia Celular
Indication/ConditionALS (Amyotrophic Lateral Sclerosis)
Intervention/Treatmentautologous mononuclear stem cell ...
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.
The cells are infused into the TA muscle of the lower limb randomized as Group A (experimental) intramuscularly. The infusion is made with a needle, 26 gauge, at 4 points of the TA muscle a specific depth given by the neurophysiological study. The total volume infused will be 2 ml, 0.5 ml at each point. For infusion is as painless as possible for the patient to comply exactly with stereotactic indications of neurophysiology, the infusion was made at a uniform controlled rate and for this, the syringe is placed on a Yesargil arm, equipped with a microinjector and controlled infusion device.
The placebo, 2ml of saline, will be infused like in the experimental arm.
All patients included in the clinical trial will receive an intramuscular infusion of autologous mononuclear cells (MNC) of Bone Marrow (BM) in TA muscle of one of the lower limb (experimental group). The lower limb on the CMN infuse autologous BM will be determined randomly. The average dose is 550 millions of cells (100-1200 million) diluted in 2 ml. saline
All patients included in the clinical trial will receive an intramuscular infusion of 2 mL of saline (placebo) in the TA muscle of the contralateral limb (group control).
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.