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:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00075335
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Mobilization and collection of PBPC using G-CSF at least 60 days prior to protocol enrollment (stem cell donors enrolled on Branch transplant protocols or healthy volunteers enrolled on 96-H-0049: Use of granulocyte colony stimulating factor mobilized leukapheresis collections from healthy volunteers).
2. Ages greater than or equal to 18 years and less than or equal to 80 years.
3. Normal renal function: creatinine less than 1.5 mg/dl.
4. Normal liver function: total bilirubin less than 1.5mg/dl, alanine aminotransferase (ALT) 6 -41 U/L, aspartate aminotransferase (AST) 9-34 U/L.
5. Normal blood count: white blood cell (WBC) 3000-10000/mm(3)
granulocytes greater than 1500/mm(3)
platelets greater than 150,000/mm(3)
hemoglobin (females greater than 11.1 g/dl, males greater than 12.7 g/dl).
6. Subject must be eligible for normal blood donation and fit to undergo apheresis procedure (antecubital veins must be adequate for peripheral access during apheresis).
7. Ability to comprehend the investigational nature of the study and provide informed consent.
EXCLUSION CRITERIA: Any of the Following
1. Active infection or history of recurrent infection- hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV and human T- lymphocytic virus (HTLV-1).
2. History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous.
3. History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin.
4. History of any hematologic disorders including thromboembolic disease.
5. History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias OR related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention OR treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk.
6. History of cerebrovascular disease, transient ischemic attack, or stroke.
7. Pregnant or lactating.
8. Severe psychiatric illness: mental deficiency sufficiently severe as to make informed consent impossible
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00075335
Study Brief:
Protocol Section:
NCT00075335