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

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.

Study Overview

• Status: Recruiting
• Conditions: Rare Diseases
• Intervention / Treatment: Behavioral: This is a non-interventional study

Detailed Description

This is a multi-center study, with up to 20,000 participants enrolled. Participants may complete up to two visits, a screening visit, and an apheresis visit, during their enrollment in the study.

The biospecimens collected by apheresis may be processed and stored, delivered frozen, or delivered unfrozen directly to the requesting researcher. All participant specimens, if processed, will be stored, and distributed to researchers in an anonymized fashion.

The following activities will occur during the study:

Sponsor Obtain overall study informed consent. Sanguine will implement a software-as-a-service (SaaS) provider of electronic signature technology and transaction management solutions and/or a hardcopy of the informed consent form (ICF). Participants may electronically sign the ICF and authorization of release of information using an electronic device. The Sponsor will also provide the participant the option of completing hardcopy documents if they so desire. In addition to the Principal Investigator (PI), approved study staff can also administer and sign the ICF and will address all of the participant's queries regarding the ICF and study design. The informed consent process can take place at the site location by the on-site staff. In addition to the overall study informed consent, sites may also administer their own ICF per site-specific procedures, if required.

Health information will be collected via self-report and medical record review to obtain a detailed clinical history of the subject's health. The health information includes but is not limited to demographic and lifestyle information, height and weight, current medications and comorbidities, date of diagnosis, condition-related treatment history, current disease characteristics, diagnostic reports, and family medical history.

Apheresis Center Laboratory tests, including, but not limited to, a complete blood count (CBC) and viral testing for hepatitis C, hepatitis B, and HIV, at a minimum, will be performed on all prospective donors.

Apheresis health questionnaire to identify potential health risks and risk of communicable disease.

Venous access check completed by an apheresis nurse to qualify donor as having adequate veins for successful apheresis.

Assessment performed by the apheresis collection center on the day of donation which may include (but is not limited to the following) Basic health questionnaire to assess donor suitability for apheresis Mini physical exam including vitals and hemoglobin measurement Other requirements of the apheresis center as per standard procedure Apheresis cell collection

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • Sanguine Biosciences
      • Contact: Sonia Lunar; Phone Number: 855-836-4759; Email: slunar@sanguinebio.com
      • Principal Investigator: Timothy Triche, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

This is a multi-center study, with up to 20,000 participants enrolled. Participants may complete up to two visits, a screening visit, and an apheresis visit, during their enrollment in the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leukopak	The studies collected biospecimens are white blood cells, specifically leukopaks.	September 2022 and September 2024

Collaborators and Investigators

• Sponsor: Sanguine Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): September 28, 2024
• Study Completion (Estimated): September 28, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Rare Diseases
• Other Study ID Numbers: SAN-BB-LEUK-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared with researchers via redacted medical records.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No