Status:
COMPLETED
Evaluation of the Spectra Optia PMN Cell Collection Procedure
Lead Sponsor:
Terumo BCT
Conditions:
Granulocyte/ Polymorphonuclear Cells
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.
Detailed Description
The purpose of this study is to compare the procedures for the collection of granulocyte/ polymorphonuclear (PMN) cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems and to establ...
Eligibility Criteria
Inclusion
- Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including:
- Blood pressure ≥ 90/50 and ≤ 200/120 mmHg,
- Pulse \> 40 and \< 100 beats/min, and
- Temperature \< 99.5ºFahrenheit (F).
- Able to read, understand, and sign an English informed consent form.
- Age ≥ 18 years.
- Weight ≥ 50kg and \< 227kg.
- Male or non-pregnant, non-nursing female (a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each mobilization).
- Acceptable screening laboratory test results prior to the first PMN cell mobilization, including:
- WBC count in the range: 3,500-10,800/uL,
- Hematocrit in the range: 38-65%,
- Platelet count in the range: 150,000-400,000/uL,
- Coagulation tests: PT not greater than 1.1 times the upper limit of the local laboratory reference range; PTT not greater than 1.2 times the upper limit of the local laboratory reference range,
- Serum electrolyte concentrations: potassium in the range 3.6-5.1 mmol/L; calcium in the range 8.5-10.3 mg/dL,
- Serum creatinine not greater than 1.5mg/dL, and
- ALT not greater than 1.5 times the upper limit of the local laboratory reference range. \*\*\* Up to two (2) of the above screening laboratory test results may fall outside of these ranges, if in the judgment of the principal investigator or designee, they do not constitute a significant risk to the subject. Any excused deviations from the above will be listed and summarized with the final report.\*\*\*
- Adequate dual peripheral venous access to allow collection of granulocytes (PMN cells) and return of remaining cells, platelets and plasma.
- If male, willing to use a condom during sexual relations with a female partner of child bearing potential until 48 hours following each G-CSF injection.
- If female, willing to use a medically-acceptable contraceptive until 48 hours following each G-CSF injection.
Exclusion
- Positive screening for any of the following: HIV, HBV (except isolated HB core Ab reactivity), HCV, HTLV, Syphilis or West Nile Virus.
- Currently pregnant or breast-feeding.
- Collection or loss of specific volumes of whole blood or blood components during specified timeframes:
- more than 550mL of whole blood within the prior 56 days, or
- more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or
- more than 12L 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.
- History of congestive heart failure.
- History of uncontrolled hypertension (SBP/DBP \>200/120 mmHg).
- History or suspicion of active, peptic ulcer disease.
- History of diabetes mellitus.
- History of hematologic malignancy or chronic hematologic disorder.
- Family history (parents, siblings, children) of hematologic malignancy.
- History of deep vein thrombosis or venous thromboembolism, or bleeding disorder.
- History of sickle cell disease or a positive SickleDex screen.
- History of iritis or episcleritis.
- History of autoimmune condition or disorder, unless approved by principal investigator.
- Presence of psychological traits, or physiological or medical conditions that, in the opinion of the investigator, would make the subject unlikely to tolerate the procedures or complete the study.
- History of use/anticipated need for lithium.
- Received a G-CSF injection in the prior 4 months.
- Known hypersensitivity to ethylene oxide.
- Known hypersensitivity to G-CSF or hypersensitivity to any E. coli-derived products.
- Known hypersensitivity to HES or corn.
- Concurrent participation in another clinical trial or participation in a clinical trial within the past 30 days.
- Subject is being treated with calcium channel blockers and/or antiepileptic medications. Note: This applies only to Subjects at Bonfils Blood Center whose collected product will undergo neutrophil function testing.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01805180
Start Date
February 1 2013
End Date
July 1 2013
Last Update
March 18 2015
Active Locations (3)
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1
Bonfils Blood Center
Denver, Colorado, United States, 80230
2
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267-0055
3
Blood Centers of Wisconsin
Milwaukee, Wisconsin, United States, 53233