An Evaluation of the Spectra Optia CMNC Collection Procedure

NCT ID: NCT02253160

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-01-31

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.

Conditions

Healthy Apheresis Donors; Mononuclear (MNC) Cell Donors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Spectra Optia CMNC first, then COBE Spectra MNC

Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.

Group Type: EXPERIMENTAL

Spectra Optia CMNC

Intervention Type: DEVICE

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 MNC

Intervention Type: DEVICE

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)

Intervention Type: DRUG

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.

COBE Spectra MNC first, then Spectra Optia CMNC

COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.

Group Type: EXPERIMENTAL

Spectra Optia CMNC

Intervention Type: DEVICE

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 MNC

Intervention Type: DEVICE

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)

Intervention Type: DRUG

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.

Interventions

Spectra Optia CMNC

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.

Intervention Type: DEVICE

COBE Spectra MNC

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.

Intervention Type: DEVICE

Granulocyte-colony stimulating factor (G-CSF)

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.

Intervention Type: DRUG

Other Intervention Names

Spectra Optia Apheresis System CMNC collection procedure; COBE Spectra Apheresis System MNC collection procedure; Mobilization Procedure

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Terumo BCT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Goodrich, PhD

Role: STUDY_DIRECTOR

Terumo BCT

Locations

Hoxworth Blood Center

Cincinnati, Ohio, United States

Key Biologics, LLC

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

CTS-5038

Identifier Type: -

Identifier Source: org_study_id