Clinical trial NCT01277549: Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
Official title: Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukapheresis
Keywords: Leukapheresis
Hematopoetic Stem Cell Mobilization
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
Collaborators: name: Versiti
name: Key Biologics, LLC
name: LeukoLab
name: Yale University
First posted: 2011-01-17
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Community Volunteers

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.


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.
* 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.

Primary outcomes:
measure: Mononuclear Cell Collection Efficiency
timeFrame: One day
measure: CD34+ Cell Collection Efficiency
timeFrame: one day
Secondary outcomes:
measure: Platelet Collection Efficiency
timeFrame: One Day
measure: Hematocrit of MNC Product
timeFrame: One Day
measure: Granulocyte % of MNC Product
timeFrame: One day
measure: Viability of the Collected MNC Product
timeFrame: One day
Other outcomes:
Locations:
city: Emeryville
country: United States
facility: Leukolab/Allcells
state: California
city: Memphis
country: United States
facility: Key Biologics
state: Tennessee
city: Milwaukee
country: United States
facility: Blood Center of Wisconsin
state: Wisconsin
Study officials:
affiliation: Terumo BCT
name: Jerome R Bill, MD
role: STUDY_DIRECTOR
References: