LeukapheresisNCT01277549

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

An observational study of Leukapheresis, run by Terumo BCT at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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)… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Leukapheresis
What is being tested?: Mononuclear cell collection.
Type of treatment: Medical device
How many people: 71 participants
Where: 3 sitesUnited States
Study dates: Jan 2011to Sep 2011
Phase: Observational
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

Study population: Healthy Community Volunteers

Who may be able to join

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.

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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.

Who cannot join

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,

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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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Leukolab/Allcells
Emeryville, California, 94608
Key Biologics
Memphis, Tennessee, 38104-3401
Blood Center of Wisconsin
Milwaukee, Wisconsin, 53233

Other trials in United States

About this study

Conditions: Leukapheresis
Being tested: Mononuclear cell collection.
Keywords: Leukapheresis, Hematopoetic Stem Cell Mobilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01277549
Study group	Role	What they receive
Non-mobilized donors		In this arm the collection efficiency of mononuclear cells from non-mobilized donors will be studied. Receives: Device: Mononuclear cell collection.
G-CSF mobilized donors		In this arm the collection efficiency of CD34+ cells will be studied. Receives: Device: Mononuclear cell collection.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mononuclear Cell Collection Efficiency
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: One day
CD34+ Cell Collection Efficiency
The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.
Measured: one day

Secondary outcomes (4)

Platelet Collection Efficiency
Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.
Measured: One Day
Hematocrit of MNC Product
The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.
Measured: One Day
Granulocyte % of MNC Product
Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.
Measured: One day
Viability of the Collected MNC Product
The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.
Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Sep 2011

First posted17 Jan 2011 (estimated)
Study startJan 2011
Primary completionSep 2011
Study completionSep 2011

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 LeukapheresisStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01277549
Sponsor's protocol ID: BCT10-03
Status last verified: May 2013
First submitted: 13 Jan 2011
Last updated: 3 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Leukapheresis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
ClinicalTrials.gov ID: NCT01277549
Acronym / sponsor ID: BCT10-03
Conditions: Leukapheresis
Keywords: Leukapheresis, Hematopoetic Stem Cell Mobilization
Study type: Observational
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Terumo BCTIndustry (pharma, biotech, devices)
Collaborators: Versiti Blood Health, Key Biologics, LLC, LeukoLab, Yale University
Study start: Jan 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 17 Jan 2011 (estimated)
Results: Posted 3 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Non-mobilized donors	–	Device: Mononuclear cell collection.In this arm the collection efficiency of mononuclear cells from non-mobilized donors will be studied.
G-CSF mobilized donors	–	Device: Mononuclear cell collection.In this arm the collection efficiency of CD34+ cells will be studied.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy Community Volunteers

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (28 listed)

a) Collection or loss of:
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.

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
Mononuclear cell collection.Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.	Device	G-CSF mobilized donors, Non-mobilized donors

Primary outcome

Mononuclear Cell Collection Efficiency
Time frame: One day
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.
CD34+ Cell Collection Efficiency
Time frame: one day
The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.

4 secondary outcomes

Platelet Collection Efficiency
Time frame: One Day
Hematocrit of MNC Product
Time frame: One Day
Granulocyte % of MNC Product
Time frame: One day
Viability of the Collected MNC Product
Time frame: One day

Results and safety

Results posted to the registry on 3 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
G-CSF Mobilized Donors	41	15
Non-mobilized Donors	29	15

Primary outcome: Mononuclear Cell Collection Efficiency

Time frame: One day. Median (Full Range). Unit: % of processed MNCs that were collected

Measure	G-CSF Mobilized Donors n = 15	Nonmobilized Donors n = 15
Value	61 (17 to 147)	57 (27 to 92)

Population analysed: Results are given for all per protocol subjects.

Primary outcome: CD34+ Cell Collection Efficiency

Time frame: one day. Median (Full Range). Unit: % of processed CD34+ cells collected

Measure	G-CSF Mobilized Donors n = 15
Value	77 (43 to 111)

Population analysed: Results are given for all per protocol subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
G-CSF Mobilized Donors	0 of 25 (0%)	19 of 25 (76%)	Not reported
Nonmobilized Donors	0 of 16 (0%)	8 of 16 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Leukapheresis

RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingPhase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Idiopathic CD4-Positive, T-Lymphocytopenia
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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Blood Donors, Apheresis
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV

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.

Jerome R Bill, MD 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?

An observational study of Leukapheresis, 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 10 inclusion and 28 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 3 May 2013. 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 3 May 2013). 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?

Mononuclear Cell Collection Efficiency (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01277549.

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 3 May 2013.