Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis

Exclusion Criteria

• •Subjects with a clinically significant preexisting lung disease not attributable to ALS.
• •Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
• •Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
• •Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
• •Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
• •Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team
• •A history of frequent adverse reactions (serious or otherwise) to blood products.
• •Hypersensitivity to albumin or allergies to any of the components of Albutein.
• •Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoagulants
• •Plasma creatinine \> 2mg/dl.
• •Present a history of heart disease including ischemic heart disease or congestive heart failure.
• •Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
• •Any condition that complicates adherence to study protocol (illness with less than one year of expected survival, drug or alcohol abuse, etc.)