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

NCT ID: NCT01277549

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-09-30

Brief Summary

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.

Conditions

Leukapheresis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-mobilized donors

In this arm the collection efficiency of mononuclear cells from non-mobilized donors will be studied.

Mononuclear cell collection.

Intervention Type: DEVICE

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.

Mononuclear cell collection.

Intervention Type: DEVICE

Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.

Interventions

Mononuclear cell collection.

Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.

Intervention Type: DEVICE

Eligibility Criteria

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.
• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Versiti

OTHER

Sponsor Role: collaborator

Key Biologics, LLC

INDUSTRY

Sponsor Role: collaborator

LeukoLab

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Terumo BCT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerome R Bill, MD

Role: STUDY_DIRECTOR

Terumo BCT

Locations

Leukolab/Allcells

Emeryville, California, United States

Key Biologics

Memphis, Tennessee, United States

Blood Center of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

BCT10-03

Identifier Type: -

Identifier Source: org_study_id