Granulocyte/ Polymorphonuclear CellsPMNCNCT01805180
Evaluation of the Spectra Optia PMN Cell Collection Procedure
A study testing Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System) and Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System) in people with Granulocyte/ Polymorphonuclear Cells, run by Terumo BCT at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Granulocyte/ Polymorphonuclear Cells
- What is being tested?
- Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System) and Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267-0055
Bonfils Blood Center
Denver, Colorado, 80230
Blood Centers of Wisconsin
Milwaukee, Wisconsin, 53233
About this study
Official title: A Controlled Evaluation of the Spectra Optia® Apheresis System's Granulocyte / Polymorphonuclear (PMN) Cell Collection Procedure
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.
Read the 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 establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.
- Conditions
- Granulocyte/ Polymorphonuclear Cells
- Being tested
- Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System), Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)Device
In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System.
Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)Device
In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Spectra Optia followed by COBE Spectra | Other | Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the Spectra Optia device followed by the COBE Spectra device. Receives: Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System); Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System) |
| Arm 2: COBE Spectra followed by Spectra Optia | Other | Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the COBE Spectra device followed by Spectra Optia. Receives: Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System); Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Granulocyte/PMN Cell Collection Efficiency
The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.
Measured: within 1 hour prior and within 5 minutes after each collection procedure
Secondary outcomes (10)
Performance
Comparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure.
Measured: within 1 hour prior and within 5 minutes after each collection procedure
Characterization of Blood Product - PMN Cell Yield
Characterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product.
Measured: within 5 minutes after each collection procedure
Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed
Characterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device.
Measured: within 5 minutes after each collection procedure
Characterization of the Blood Product - PMN Cell Viability
Characterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product.
Measured: within 5 minutes after collection procedure
Characterization of the Blood Product - RBC Contamination
Characterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product.
Measured: within 5 minutes after collection procedure
Characterization of the Blood Product - Volume
Characterization of the collected blood product, specifically product volume.
Measured: within 5 minutes after collection procedure
Usability/Assessment of System Operation - Time
Procedure time for collections on the Spectra Optia vs. the COBE Spectra.
Measured: Result captured immediately upon completion of procedure
Usability/Assessment of System Operation - Adjustments
Number of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate.
Measured: Adjustments known immediately upon completion of the procedure
Usability/Assessment of System Operation - Device Malfunctions
Measured: Result know immediately upon successful completion of procedure
Safety
- Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs).
- any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA.
Measured: 48-hours after last procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Granulocyte/ Polymorphonuclear CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond Goodrich, Ph.D, Study director, Terumo BCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805180
- Sponsor's protocol ID
- CTS-5010
- Acronym
- PMNC
- Status last verified
- Feb 2015
- First submitted
- 1 Mar 2013
- Last updated
- 18 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Evaluation of the Spectra Optia® Apheresis System's Granulocyte / Polymorphonuclear (PMN) Cell Collection Procedure
- ClinicalTrials.gov ID
- NCT01805180
- Acronym / sponsor ID
- PMNC / CTS-5010
- Conditions
- Granulocyte/ Polymorphonuclear Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Terumo BCTIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Posted 26 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Spectra Optia followed by COBE Spectra | Other | Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System), Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the Spectra Optia device followed by the COBE Spectra device. |
| Arm 2: COBE Spectra followed by Spectra Optia | Other | Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System), Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the COBE Spectra device followed by Spectra Optia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including:
- 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).
Key exclusion criteria (27 listed)
- 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:
- History of congestive heart failure.
- History of uncontrolled hypertension (SBP/DBP >200/120 mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System. | Device | Arm 1: Spectra Optia followed by COBE Spectra, Arm 2: COBE Spectra followed by Spectra Optia |
| Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System. | Device | Arm 1: Spectra Optia followed by COBE Spectra, Arm 2: COBE Spectra followed by Spectra Optia |
Primary outcome
Granulocyte/PMN Cell Collection Efficiency
Time frame: within 1 hour prior and within 5 minutes after each collection procedure
The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.
10 secondary outcomes
Performance
Time frame: within 1 hour prior and within 5 minutes after each collection procedure
Characterization of Blood Product - PMN Cell Yield
Time frame: within 5 minutes after each collection procedure
Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed
Time frame: within 5 minutes after each collection procedure
Characterization of the Blood Product - PMN Cell Viability
Time frame: within 5 minutes after collection procedure
Characterization of the Blood Product - RBC Contamination
Time frame: within 5 minutes after collection procedure
Characterization of the Blood Product - Volume
Time frame: within 5 minutes after collection procedure
Usability/Assessment of System Operation - Time
Time frame: Result captured immediately upon completion of procedure
Usability/Assessment of System Operation - Adjustments
Time frame: Adjustments known immediately upon completion of the procedure
Usability/Assessment of System Operation - Device Malfunctions
Time frame: Result know immediately upon successful completion of procedure
Safety
Time frame: 48-hours after last procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Goodrich, Ph.D study director
Terumo BCT
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System) and Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System) in people with Granulocyte/ Polymorphonuclear Cells, run by Terumo BCT at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Granulocyte/PMN Cell Collection Efficiency (time frame: within 1 hour prior and within 5 minutes after each collection procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.