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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02253160
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 and ≤ 50 years of age
2. Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)
a) Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study
3. Adequate dual peripheral venous access
4. Acceptable prescreening laboratory results prior to MNC mobilization as specified below:
a) WBC 3,500 - 10,800/µL
b) Hematocrit 38% - 56%
c) Platelets 150,000 - 400,000/µL
d) Coagulation tests:
i. PT 9.0 - 13.0 seconds
ii. PTT 23.4 - 41.8 seconds
e) Serum electrolytes:
i. Potassium 3.6 - 5.1 mmol/L
ii. Serum Calcium 8.5 mg/dL - 10.3 mg/dL
f) Renal function: Serum creatinine ≤ 1.5 mg/dL
NOTE: up to two laboratory results may fall out of the ranges listed above if, in the judgment of the investigator, they do not constitute a significant risk to the subject.
5. Liver function: alanine aminotransferase (ALT) \< 1.5 times the upper limit of normal
6. Willing to avoid pregnancy until at least 48 hours following last G-CSF injection
1. If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection
2. If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection
7. Given written informed consent
Exclusion Criteria:
1. Previous MNC collection failure
2. Known hypersensitivity or condition that prevents the use of anticoagulants
3. Known hypersensitivity or condition that prevents the use of G-CSF
4. Known hemoglobinopathy including sickle cell trait or disease
5. History of use in the past week or anticipated need for lithium
6. Concurrent enrollment in another clinical study that could impact the results or participation in this study
7. Active infection or any serious underlying medical condition that contraindicates apheresis
8. Women who are pregnant or lactating
9. Known history of significant head trauma
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02253160
Study Brief:
Protocol Section:
NCT02253160