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 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT02821806
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age greater than or equal to 18 years old and able to give consent.
* Adequate clinical parameters (all of the following):
* Afebrile (temperature less than or equal to 37.5 degree C)
* Systolic blood pressure less than or equal to180 mmHg
* Diastolic blood pressure less than or equal to100 mmHg
* Weight greater than or equal to 110 lbs.
* Heart rate between 50-100 beats/minute
* Adequate bilateral antecubital venous access for a 2 arm apheresis procedure
* Females of child-bearing potential should not be pregnant or breast-feeding.
* Within 30 days of pheresis donation, donors must be negative for infectious disease work-up: Antibody screen for Hepatitis B, Hepatitis C; HIV, HTLV-I/II, T. cruzi (Chagas agent), West Nile, and syphilis (RPR)
* Within 30 days of pheresis donation, donor must have:
* Hemoglobin:
* Women greater than or equal to 12.5 gm/dL
* Men greater than or equal to 13.0 gm/dL
* Platelets greater than or equal to 100,000/microliter
* Total WBC greater than or equal to 2 K/microliter
EXCLUSION CRITERIA:
* History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.
* Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.
* Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.
* Active malignancy will exclude the donor. Any history of malignancy will be considered on a case by case basis in accordance with NIH/DTM criteria.
* If the participant answers Yes to any initial screening question, the participant will be considered ineligible.
* If the participant is deferred according to DTM Cellular Therapy Screening Standard Operating Procedures (SOP), the participant will be considered ineligible.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT02821806
Study Brief:
Protocol Section:
NCT02821806