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

Recruiting now

Conditions studied: Rare Diseases

In brief

To collect, preserve, and distribute annotated leukopak biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions. This protocol will be utilized to collect research grade products that are not meant for transfusion.

Key facts

Study ID

NCT05794217

Run by

Sanguine Biosciences

People needed

20000

Starts

2022-09-28

Expected to finish

2026-12-31

Last updated by the study team

2024-12-06

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanguine Biosciences — Waltham, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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