Clinical trial NCT02253160: An Evaluation of the Spectra Optia CMNC Collection Procedure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Apheresis Donors
Mononuclear (MNC) Cell Donors
Keywords: MNCs
Mononuclear Cells
Apheresis
Spectra Optia
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 and ≤ 50 years of age
2. Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)

   a) Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study
3. Adequate dual peripheral venous access
4. Acceptable prescreening laboratory results prior to MNC mobilization as specified below:

   a) WBC 3,500 - 10,800/µL

   b) Hematocrit 38% - 56%

   c) Platelets 150,000 - 400,000/µL

   d) Coagulation tests:

   i. PT 9.0 - 13.0 seconds

   ii. PTT 23.4 - 41.8 seconds

   e) Serum electrolytes:

   i. Potassium 3.6 - 5.1 mmol/L

   ii. Serum Calcium 8.5 mg/dL - 10.3 mg/dL

   f) 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.
5. Liver function: alanine aminotransferase (ALT) \< 1.5 times the upper limit of normal
6. Willing to avoid pregnancy until at least 48 hours following last G-CSF injection

   1. If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection
   2. If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection
7. Given written informed consent

Exclusion Criteria:

1. Previous MNC collection failure
2. Known hypersensitivity or condition that prevents the use of anticoagulants
3. Known hypersensitivity or condition that prevents the use of G-CSF
4. Known hemoglobinopathy including sickle cell trait or disease
5. History of use in the past week or anticipated need for lithium
6. Concurrent enrollment in another clinical study that could impact the results or participation in this study
7. Active infection or any serious underlying medical condition that contraindicates apheresis
8. Women who are pregnant or lactating
9. Known history of significant head trauma

Primary outcomes:
measure: CD34+ Collection Efficiency (CE1 %)
timeFrame: within 5 minutes upon completion of procedure
Secondary outcomes:
measure: CD34+ Collection Efficiency (CE2 %)
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Collection Efficiency (CE1%)
timeFrame: within 5 minutes upon completion of procedure
measure: CD34+ Per kg of Body Weight
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Hematocrit (%)
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Blood Product Volume (mL)
timeFrame: within 5 minutes upon completion of procedure
measure: Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)
timeFrame: within 5 minutes upon completion of procedure
measure: Procedure Time (Minutes)
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Collection Efficiency (CE2%)
timeFrame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity - RBC Concentration (10^6/µL)
timeFrame: within 5 minutes upon completion of procedure
Other outcomes:
measure: Device Deficiencies
timeFrame: 24-hours after last collection procedure
measure: Post-collection Platelet Loss in Subject
timeFrame: 24-hours after last collection procedure
Locations:
city: Cincinnati
country: United States
facility: Hoxworth Blood Center
state: Ohio
city: Memphis
country: United States
facility: Key Biologics, LLC
state: Tennessee
Study officials:
affiliation: Terumo BCT
name: Raymond Goodrich, PhD
role: STUDY_DIRECTOR
References: