An Evaluation of the Spectra Optia CMNC Collection Procedure

Terumo BCT23 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Apheresis Donors Mononuclear (MNC) Cell Donors

Interventions

Spectra Optia CMNCDEVICE

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

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hoxworth Blood Center

Cincinnati, Ohio, United States

Key Biologics, LLC

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: within 5 minutes upon completion of procedure

Secondary Outcomes

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.

Time frame: 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.

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 (%)

Data from ClinicalTrials.gov

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