Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT03085706
Eligibility Criteria:
Inclusion Criteria:
* all subjects had a verifiable diagnosis of ALS for 0.5 to 2 years based on a diagnosis using the Revised Criteria of the World Federation of Neurology. The grades of diagnosis were clinically definite ALS or clinically probable ALS;
* ALS was mild-to-moderate based on the ALS Functional Rating Scale-Revised. Electrophysiological features showed compound muscle action potential (CMAP) amplitude of motor nerve normal or mild declining;
* serum creatine kinase was normal or mild upper, less than 500 U/L.
Exclusion Criteria:
* use of any other investigational agent within 30 days before treatment;
* severe cardiac, pulmonary, hepatic or/and hematic disease;
* human immunodeficiency virus positivity or signs and symptoms consistent with human immunodeficiency virus infection;
* pregnant or nursing women;
* history of cancer with less than 5 years documentation of a disease-free state;
* history of anaphylactic reaction or hypersensitivity to granulocyte colony- stimulating factor (G-CSF);
* alcohol or drug abuse in recent 1 year;
* cannot understand or obey the rules of treatment;
* blood donor in recent 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
31 Years
Maximum Age:
75 Years
Study:
NCT03085706
Study Brief:
Protocol Section:
NCT03085706