Healthy Apheresis DonorsCMNCNCT02253160
An Evaluation of the Spectra Optia CMNC Collection Procedure
A study testing Spectra Optia CMNC, COBE Spectra MNC and Granulocyte-colony stimulating factor (G-CSF) in people with Healthy Apheresis Donors and Mononuclear (MNC) Cell Donors, run by Terumo BCT at 2 sites in United States.
Trial summary
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Apheresis Donors, Mononuclear (MNC) Cell Donors
- What is being tested?
- Spectra Optia CMNC, COBE Spectra MNC and Granulocyte-colony stimulating factor (G-CSF)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Jan 2015
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥ 18 and ≤ 50 years of age
- Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)
- Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study
- Adequate dual peripheral venous access
- Acceptable prescreening laboratory results prior to MNC mobilization as specified below:
- WBC 3,500 - 10,800/µL
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- Hematocrit 38% - 56%
- Platelets 150,000 - 400,000/µL
- Coagulation tests:
- PT 9.0 - 13.0 seconds
- PTT 23.4 - 41.8 seconds
- Serum electrolytes:
- Potassium 3.6 - 5.1 mmol/L
- Serum Calcium 8.5 mg/dL - 10.3 mg/dL
- Renal function: Serum creatinine ≤ 1.5 mg/dL
- NOTE: up to two laboratory results may fall out of the ranges listed above if, in the judgment of the investigator, they do not constitute a significant risk to the subject.
- Liver function: alanine aminotransferase (ALT) < 1.5 times the upper limit of normal
- Willing to avoid pregnancy until at least 48 hours following last G-CSF injection
- 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
- Given written informed consent
Who cannot join
- Previous MNC collection failure
- Known hypersensitivity or condition that prevents the use of anticoagulants
- Known hypersensitivity or condition that prevents the use of G-CSF
- Known hemoglobinopathy including sickle cell trait or disease
- History of use in the past week or anticipated need for lithium
- Concurrent enrollment in another clinical study that could impact the results or participation in this study
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- Active infection or any serious underlying medical condition that contraindicates apheresis
- Women who are pregnant or lactating
- Known history of significant head trauma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267-0055
Key Biologics, LLC
Memphis, Tennessee, 38104
About this study
Official title: A Randomized, Crossover Trial to Characterize the Performance of the Spectra Optia Apheresis System Versus the COBE Spectra Apheresis System for Collection of Mononuclear Cells in Healthy Adult Donors
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the last collection.
Read the detailed description
This is a prospective, randomized, cross-over, multi-center study to evaluate the performance of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra system's MNC Procedure in mobilized healthy donors.
Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects. Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE Spectra MNC collection procedure first, followed by the opposite on the following day.
Study participation will be up to 14 days: a 7-day screening period, four days for mobilization, one day for the first MNC collection with additional dose of mobilization, one day for the second MNC collection, and safety follow-up the following day.
Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the second collection.
- Being tested
- Spectra Optia CMNC, COBE Spectra MNC, Granulocyte-colony stimulating factor (G-CSF)
- Keywords
- MNCs, Mononuclear Cells, Apheresis, Spectra Optia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectra Optia CMNCDevice
Also called Spectra Optia Apheresis System CMNC collection procedure
The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNCDevice
Also called COBE Spectra Apheresis System MNC collection procedure
It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.
Granulocyte-colony stimulating factor (G-CSF)Drug
Also called Mobilization Procedure
Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.
| Study group | Role | What they receive |
|---|---|---|
| Spectra Optia CMNC first, then COBE Spectra MNC | Experimental | Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure. Receives: Device: Spectra Optia CMNC; Device: COBE Spectra MNC; Drug: Granulocyte-colony stimulating factor (G-CSF) |
| COBE Spectra MNC first, then Spectra Optia CMNC | Experimental | COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure. Receives: Device: Spectra Optia CMNC; Device: COBE Spectra MNC; Drug: Granulocyte-colony stimulating factor (G-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD34+ Collection Efficiency (CE1 %)
The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) 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 CMNC collection procedure. 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.
Measured: within 5 minutes upon completion of procedure
Secondary outcomes (12)
CD34+ Collection Efficiency (CE2 %)
Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. 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.
Measured: within 5 minutes upon completion of procedure
MNC Collection Efficiency (CE1%)
Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. 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.
Measured: within 5 minutes upon completion of procedure
CD34+ Per kg of Body Weight
Measured: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Hematocrit (%)
Measured: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)
Measured: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)
Measured: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)
Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. 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.
Measured: within 5 minutes upon completion of procedure
MNC Blood Product Volume (mL)
The produced unit of MNCs collected into the blood bag.
Measured: within 5 minutes upon completion of procedure
Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)
A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.
Measured: within 5 minutes upon completion of procedure
Procedure Time (Minutes)
Measured: within 5 minutes upon completion of procedure
MNC Collection Efficiency (CE2%)
Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. 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.
Measured: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity - RBC Concentration (10^6/µL)
Measured: within 5 minutes upon completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
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 Healthy Apheresis DonorsStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond Goodrich, PhD, Study director, Terumo BCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253160
- Sponsor's protocol ID
- CTS-5038
- Acronym
- CMNC
- Status last verified
- Aug 2015
- First submitted
- 23 Sep 2014
- Last updated
- 24 Sep 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 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Trial to Characterize the Performance of the Spectra Optia Apheresis System Versus the COBE Spectra Apheresis System for Collection of Mononuclear Cells in Healthy Adult Donors
- ClinicalTrials.gov ID
- NCT02253160
- Acronym / sponsor ID
- CMNC / CTS-5038
- Keywords
- MNCs, Mononuclear Cells, Apheresis, Spectra Optia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Terumo BCTIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 24 Sep 2015
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 prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the last collection.
Detailed description
This is a prospective, randomized, cross-over, multi-center study to evaluate the performance of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra system's MNC Procedure in mobilized healthy donors.
Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects. Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE Spectra MNC collection procedure first, followed by the opposite on the following day.
Study participation will be up to 14 days: a 7-day screening period, four days for mobilization, one day for the first MNC collection with additional dose of mobilization, one day for the second MNC collection, and safety follow-up the following day.
Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the second collection.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spectra Optia CMNC first, then COBE Spectra MNC | Experimental | Device: Spectra Optia CMNC, Device: COBE Spectra MNC, Drug: Granulocyte-colony stimulating factor (G-CSF)Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure. |
| COBE Spectra MNC first, then Spectra Optia CMNC | Experimental | Device: Spectra Optia CMNC, Device: COBE Spectra MNC, Drug: Granulocyte-colony stimulating factor (G-CSF)COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- ≥ 18 and ≤ 50 years of age
- Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)
- Adequate dual peripheral venous access
- Acceptable prescreening laboratory results prior to MNC mobilization as specified below:
- NOTE: up to two laboratory results may fall out of the ranges listed above if, in the judgment of the investigator, they do not constitute a significant risk to the subject.
Key exclusion criteria (9 listed)
- Previous MNC collection failure
- Known hypersensitivity or condition that prevents the use of anticoagulants
- Known hypersensitivity or condition that prevents the use of G-CSF
- Known hemoglobinopathy including sickle cell trait or disease
- History of use in the past week or anticipated need for lithium
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 |
|---|---|---|
| Spectra Optia CMNCAlso: Spectra Optia Apheresis System CMNC collection procedureThe Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood. | Device | COBE Spectra MNC first, then Spectra Optia CMNC, Spectra Optia CMNC first, then COBE Spectra MNC |
| COBE Spectra MNCAlso: COBE Spectra Apheresis System MNC collection procedureIt is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled. | Device | COBE Spectra MNC first, then Spectra Optia CMNC, Spectra Optia CMNC first, then COBE Spectra MNC |
| Granulocyte-colony stimulating factor (G-CSF)Also: Mobilization ProcedureEach subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure. | Drug | COBE Spectra MNC first, then Spectra Optia CMNC, Spectra Optia CMNC first, then COBE Spectra MNC |
Primary outcome
CD34+ Collection Efficiency (CE1 %)
Time frame: within 5 minutes upon completion of procedure
The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) 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 CMNC collection procedure. 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.
12 secondary outcomes
CD34+ Collection Efficiency (CE2 %)
Time frame: within 5 minutes upon completion of procedure
MNC Collection Efficiency (CE1%)
Time frame: within 5 minutes upon completion of procedure
CD34+ Per kg of Body Weight
Time frame: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Hematocrit (%)
Time frame: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)
Time frame: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)
Time frame: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)
Time frame: within 5 minutes upon completion of procedure
MNC Blood Product Volume (mL)
Time frame: within 5 minutes upon completion of procedure
Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)
Time frame: within 5 minutes upon completion of procedure
Procedure Time (Minutes)
Time frame: within 5 minutes upon completion of procedure
MNC Collection Efficiency (CE2%)
Time frame: within 5 minutes upon completion of procedure
MNC Product Contamination/Purity - RBC Concentration (10^6/µL)
Time frame: within 5 minutes upon completion of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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, PhD study director
Terumo BCT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectra Optia CMNC, COBE Spectra MNC and Granulocyte-colony stimulating factor (G-CSF) in people with Healthy Apheresis Donors and Mononuclear (MNC) Cell Donors, run by Terumo BCT at 2 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 21 inclusion and 9 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 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 24 Sep 2015). 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?
CD34+ Collection Efficiency (CE1 %) (time frame: within 5 minutes upon completion of 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 24 Sep 2015.