title: Breathing pattern in a phase I clinical trial of intraspinal injection of autologous bone marrow mononuclear cells in patients with amyotrophic lateral sclerosis.
abstract: The safety of autologous bone marrow mononuclear cells (ABMNC) intraspinal infusion in amyotrophic lateral sclerosis (ALS) patients was evaluated considering breathing and sleep patterns. Patients between 20 and 65 years old were eligible if they had definite ALS, spinal onset, a disease duration between 6 and 36 months, FVC>50%, and a below 90% oxygen saturation (T90) <2% of sleep time. The transplant was performed 6 months after enrollment. ABMNC were infused at thoracic 3-4 level. Eleven patients were included. The REM sleep decreased slightly one year after the cell transplant but not significantly. There were no differences in apnea-hipopnea index, mean oxygen saturation and nadir desaturation evolution. An increase of T90 was observed 180 and 360 days after injection (2.95±1.51% and 4.30±4.10% respectively), although it was not statistically significant. The central drive determined by occlusion pressure (P01) and inspiratory flow showed non-significant differences after one year. Intramedullary injection of ABMNC did not worsen the cortico medullar diaphragmatic pathways.
authors.affiliation: Pneumology Service, Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain. Electronic address: fjose.ruiz1@um.es.
authors.forename: Francisco José
authors.initials: FJ
authors.lastname: Ruiz-López
authors.affiliation: Pneumology Service, Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain.
authors.forename: Julia
authors.initials: J
authors.lastname: Guardiola
authors.affiliation: Neurophisiology Service,Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain.
authors.forename: Virginia
authors.initials: V
authors.lastname: Izura
authors.affiliation: Hematopoietic Progenitors Transplant and Cell Therapy Unit, Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain; Neurology Service Morales Meseguer Hospital, Murcia University, Murcia, Spain.
authors.forename: Joaquín
authors.initials: J
authors.lastname: Gómez-Espuch
authors.affiliation: Hematopoietic Progenitors Transplant and Cell Therapy Unit, Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain.
authors.forename: Francisca
authors.initials: F
authors.lastname: Iniesta
authors.affiliation: Hematopoietic Progenitors Transplant and Cell Therapy Unit, Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Blanquer
authors.affiliation: Statistical Analysis, Fundación para la Formación e Investigación Sanitarias de la Región de Murcia, Virgen de la Arrixaca Hospital, Murcia University, Murcia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: López-San Román
authors.affiliation: Neurophisiology Service,Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain.
authors.forename: Vicenta
authors.initials: V
authors.lastname: Saez
authors.affiliation: Neurophisiology Service,Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: De Mingo
authors.affiliation: Instituto de Neurociencias, UMH-CSIC, Alicante, Spain.
authors.forename: Salvador
authors.initials: S
authors.lastname: Martínez
authors.affiliation: Hematopoietic Progenitors Transplant and Cell Therapy Unit, Virgen de la Arrixaca Hospital, Murcia University, IMIB, Murcia, Spain.
authors.forename: Jose María
authors.initials: JM
authors.lastname: Moraleda
mesh_terms: D000328:Adult; D000690:Amyotrophic Lateral Sclerosis / Q000150:complications* / Q000601:surgery*; D016026:Bone Marrow Transplantation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007278:Injections, Spinal; D007963:Leukocytes, Mononuclear / Q000502:physiology / Q000637:transplantation; D008171:Lung Diseases / Q000209:etiology* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010101:Oxygen Consumption; D017286:Polysomnography; D012119:Respiration; D012893:Sleep Wake Disorders / Q000209:etiology / Q000601:surgery; D013147:Spirometry; D016896:Treatment Outcome
keywords: Amyothophic lateral sclerosis; Sleep; Stem cell