Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Albumin
Intervention description: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
three weeks of intensive treatment with two plasma exchanges per week
twenty-one weeks of maintenance treatment with one weekly plasma exchange
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: plasma exchange; albumin

Summary:

      Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5%
      albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic
      Lateral Sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written-informed consent.

          -  Subjects over 18 years of age, and less than 70 years old.

          -  Subjects with a definite, possible, or probable diagnosis of ALS, according to the
             revised El Escorial criteria.

          -  Subjects having experienced their first ALS symptoms within 18 months before
             recruitment/consent.

          -  FVC > 70%

          -  Subjects must be medically suitable for study participation and of complying with all
             planned aspects of the protocol including blood sampling at the time of inclusion in
             the study.

        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.)