Clinical Trials

Inclusion Criteria: 

• Non-pregnant subjects, adults aged 18 > 60 years of age (pregnancy status may be confirmed by a pregnancy test prior to donation)

Exclusion Criteria:

Healthy Donor Cohort

• Malignancy (including history of melanoma and any form of skin cancer < 6mos from diagnosis)
• Autoimmune disorders, including but not limited to: Rheumatoid arthritis, Type I diabetes, Crohn’s Disease (IBD)
• Adults lacking the capacity to consent
• Females that are pregnant (by laboratory testing) or breastfeeding (by self-report)
• Unwilling or unable to sign the informed consent form
• Medications – including immunomodulatory agents
• Infectious disease within 21 days (by self-report)
• Ineligible for apheresis procedure due to donor weight and hematocrit at the time of collection (based on self-reported gender)
• Abnormal calcium (ionized), magnesium, sodium, or potassium blood electrolyte level 2,3
• Abnormal CBC panel with differential 2,3
• Known genetic disorder (by self-report)
• Unacceptable peripheral veinous access for apheresis per apheresis RN evaluation (central line access will not be pursued)
• Physician review 
• Medical records review

Diseased Donor Cohort

• Adults lacking the capacity to consent
• Females that are pregnant (by laboratory testing) or breastfeeding (by self-report)
• Unwilling or unable to sign the informed consent form
• Infectious disease within 21 days (by self-report)
• Ineligible for apheresis procedure due to donor weight and hematocrit at the time of collection (based on self-reported gender)
• Unacceptable peripheral veinous access for apheresis per apheresis RN evaluation (central line access will not be prospectively pursued for this collection)
  • NOTE: If donor already has central line access (Mahurkar or Palindrome only), peripheral access may not be needed and the central line may be used. In this situation a donor is eligible for participation provided suitability testing is acceptable.
• Physician review
• Medical records review

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/26/2024. Questions regarding updates should be directed to the study team contact.