A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives

Launched by SANGUINE BIOSCIENCES · Mar 20, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on collecting and preserving special blood samples known as leukopaks. These samples, along with important health information, will be used in approved research studies to help find new ways to treat and prevent rare diseases. By gathering these materials, researchers hope to develop better diagnostics and treatments for complex health conditions.

To participate in this trial, you need to be between 18 and 89 years old, weigh at least 110 pounds, and be generally healthy. This means having a stable pulse and blood pressure, and passing certain health tests. You should also not have any serious medical conditions that might make the procedure risky. If you decide to join the study, you will undergo a procedure called apheresis, where your blood will be collected in a safe way, and you will be monitored throughout. Your participation will help advance important research that could benefit many people with rare diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Persons deemed healthy enough for the procedure and aged 18 to 89 years at the date of informed consent.
• • Minimum weight of 110 lbs. Pulse greater than 50 and less than 110 beats per minute Blood Pressure diastolic greater than 50 mmHg and less than100 mmHG and systolic is greater than 90 mmHg and less than 180 mmHg Peripheral veinous access is deemed adequate for apheresis as determined by apheresis staff.
• • Negative for Hepatitis B, Hepatitis C, and HIV 1-2 upon testing performed within 30 days, unless specifically obtaining cell collection based upon this diagnosis.
• CBC results which fall within site-specific parameters within 30 days of apheresis procedure:
• • The participant understands the procedures and requirements of the study by providing written informed consent, including consent for authorization for protected health information disclosure.
• Exclusion Criteria:
• • Persons younger than 18 years of age or older than 89 years of age at the date of informed consent.
• • Presenting with a history of a specific condition determined through medical evaluation to be incompatible with safely undergoing apheresis Receipt of transfusion of blood products within 30 days of the study procedure. Receipt of an investigational (unapproved) drug 30 days before the study procedure.
• A confirmable diagnosis of any medical condition that would increase potential procedure risks. Such medical conditions include:
• • Severe or untreated cardiovascular, kidney, liver, or lung diseases which would preclude apheresis procedures; Bleeding disorders Conditions associated with chronic anemia Active systemic infection Use of ACE inhibitors unless they can safely be held for 24 hours prior to apheresis procedure Pregnancy Has donated a unit of blood within the last 2 months at the date of informed consent.
• • Unable to understand the procedures and requirements of the study in order to provide written informed consent, including consent for authorization for protected health information disclosure.
• • Requires a Legally Authorized Representative (LAR) for the study informed consent.