Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors

May 2, 2013 updated by: Terumo BCT
The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Emeryville, California, United States, 94608
        • Leukolab/Allcells
    • Tennessee
      • Memphis, Tennessee, United States, 38104-3401
        • Key Biologics
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Blood Center of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Community Volunteers

Description

Inclusion Criteria:

  • Acceptable health history to allow blood product collection
  • Weight >50<125 Kg (kilogram).
  • Male or non-pregnant, non-nursing female.
  • General good health, as determined by questionnaire.
  • Normal prescreening complete blood count.
  • Platelet count>150 x 10^3/uL (microliter) at initial screening and >120 x 10^3/uL immediately prior to leukapheresis.
  • Adequate peripheral venous access to allow collection of product.
  • Able to read, understand, and sign the informed consent form. Additional Inclusion Criteria for Mobilized Subjects
  • If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection.
  • If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection.

Exclusion Criteria:

  • a) Collection or loss of:

    • more than a ½ pint (1 cup) of whole blood within the prior 56 days or,
    • more than 3 L (liter) of whole blood or 1.5 L of red blood cells within the prior 12 months or,
    • more than 12 L of plasma within the prior 12 months or,
    • a leukapheresis within the prior six weeks or,
    • a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months or,
    • a plasmapheresis within the prior 48 hours or two within the prior 7 days.
  • Acute or symptomatic chronic lung disease.
  • Active or chronic heart disease, including hypertension controlled by medication.
  • History of hematologic malignancy or chronic hematologic disorder or bleeding disorder.
  • Reactive test indicative of infection with T. pallidum, Human T-lymphotropic virus, HIV, Hepatitis C Virus, or Hepatitis B Virus (except isolated Hepatitis B Core Antibody Reactivity.
  • Presence of psychological traits or physiological or medical conditions that would make subject unlikely to tolerate the procedures.
  • Subjects taking prescription medications other than those deemed allowable by the investigator.
  • Abnormal serum electrolytes or serum calcium levels.
  • Abnormal serum creatinine level.
  • Abnormal liver function results on ALT (alanine amino transferase) test.
  • Abnormal coagulation testing on prothrombin time or partial thromboplastin time.
  • Inadequate antecubital veins for leukapheresis or inability or unwillingness to tolerate leukapheresis.
  • If female, pregnant or lactating. Additional Exclusion Criteria for Mobilized Subjects
  • Received a G-CSF injection in the prior 4 months, or received more than twenty-five (25) doses of G-CSF (a dose includes several individual injections administered on one occasion).
  • Known hypersensitivity to G-CSF or any E. coli-derived products.
  • History of autoimmune condition or disorder, unless approved by principal investigator.
  • Immediate family history (parents, grandparents, siblings, children) of hematologic malignancy.
  • Active or history of iritis (anterior uveitis) or episcleritis.
  • History of deep vein thrombosis or pulmonary embolism.
  • Current treatment with lithium.
  • Spleen tip palpable during physical exam.
  • Positive SickleDex test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non-mobilized donors
In this arm the collection efficiency of mononuclear cells from non-mobilized donors will be studied.
Device: Mononuclear cell collection.
Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.
G-CSF mobilized donors
In this arm the collection efficiency of CD34+ cells will be studied.
Device: Mononuclear cell collection.
Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mononuclear Cell Collection Efficiency
Time Frame: One day
The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
One day
CD34+ Cell Collection Efficiency
Time Frame: one day
The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.
one day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Platelet Collection Efficiency
Time Frame: One Day
Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.
One Day
Hematocrit of MNC Product
Time Frame: One Day
The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.
One Day
Granulocyte % of MNC Product
Time Frame: One day
Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.
One day
Viability of the Collected MNC Product
Time Frame: One day
The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Terumo BCT

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yale University
Versiti
Key Biologics, LLC
LeukoLab

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jerome R Bill, MD, Terumo BCT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCT10-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings