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:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01019733
Eligibility Criteria:
Inclusion Criteria:
* Patients with hypoxic/ischemic brain injury, with an between 1 month and 18 years, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours.
Exclusion Criteria:
* Patients with neurodegenerative or autoimmune diseases.
* Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure.
* Patients who do not sign the informed consent form.
Elimination Criteria
* Patients with severe meningeal abnormalities at the time of procedure.
* Patients who did not attend subsequent assessments 30 and 180 days after the procedure.
* Patients who die from causes related to neurological disease within 180 days after procedure.
* Patients who are diagnosed with neurodegenerative or autoimmune diseases after the procedure.
* Patients who do not bear the proper stimulation process with Granulocyte Colony Stimulating Factor (G-CSF), either by misapplication, lack thereof, or severe adverse drug reaction.
* Patients choosing to leave the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
8 Years
Study:
NCT01019733
Study Brief:
Protocol Section:
NCT01019733