An Evaluation of the Spectra Optia CMNC Collection Procedure

NCT02253160 | Completed Results

• 1 other identifier: CTS-5038
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Apheresis Donors; Mononuclear (MNC) Cell Donors

Keywords

MNCs; Mononuclear Cells; Apheresis; Spectra Optia

Outcome Measures

Primary Outcomes (1)

• 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.

  within 5 minutes upon completion of procedure

Secondary Outcomes (12)

• CD34+ Collection Efficiency (CE2 %)

  within 5 minutes upon completion of procedure

• MNC Collection Efficiency (CE1%)

  within 5 minutes upon completion of procedure

• CD34+ Per kg of Body Weight

  within 5 minutes upon completion of procedure

• MNC Product Contamination/Purity (%) - Hematocrit (%)

  within 5 minutes upon completion of procedure

• MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)

  within 5 minutes upon completion of procedure

Other Outcomes (2)

• Device Deficiencies

  24-hours after last collection procedure

• Post-collection Platelet Loss in Subject

  24-hours after last collection procedure

Study Arms (2)

Spectra Optia CMNC first, then COBE Spectra MNC

EXPERIMENTAL

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

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.

Device: Spectra Optia CMNC; Device: COBE Spectra MNC; Drug: Granulocyte-colony stimulating factor (G-CSF)

Interventions

Spectra Optia CMNC 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.

Also known as: Spectra Optia Apheresis System CMNC collection procedure

COBE Spectra MNC first, then Spectra Optia CMNC; Spectra Optia CMNC first, then COBE Spectra MNC

COBE Spectra MNC 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.

Also known as: COBE Spectra Apheresis System MNC collection procedure

COBE Spectra MNC first, then Spectra Optia CMNC; Spectra Optia CMNC first, then COBE Spectra MNC

Granulocyte-colony stimulating factor (G-CSF) 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.

Also known as: Mobilization Procedure

COBE Spectra MNC first, then Spectra Optia CMNC; Spectra Optia CMNC first, then COBE Spectra MNC

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 18 and ≤ 50 years of age
• 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
• Adequate dual peripheral venous access
• 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

You may not qualify if:

• 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
• Active infection or any serious underlying medical condition that contraindicates apheresis
• Women who are pregnant or lactating
• Known history of significant head trauma

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (2)

Hoxworth Blood Center

Cincinnati, Ohio, 45267-0055, United States

Location

Key Biologics, LLC

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer - BBT
• Organization: Terumo BCT

Ray.Goodrich@terumobct.com

303-232-6800

Study Officials

• Raymond Goodrich, PhD

  Terumo BCT

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 24, 2015
• Results First Posted: September 24, 2015

Record last verified: 2015-08

Locations

US (2)