Status:
COMPLETED
An Evaluation of the Spectra Optia CMNC Collection Procedure
Lead Sponsor:
Terumo BCT
Conditions:
Healthy Apheresis Donors
Mononuclear (MNC) Cell Donors
Eligibility:
All Genders
18-50 years
Phase:
NA
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 Spect...
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 Procedu...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
- Liver function: alanine aminotransferase (ALT) \< 1.5 times the upper limit of normal
- Willing to avoid pregnancy until at least 48 hours following last G-CSF injection
- 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
- Given written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02253160
Start Date
September 1 2014
End Date
January 1 2015
Last Update
September 24 2015
Active Locations (2)
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1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267-0055
2
Key Biologics, LLC
Memphis, Tennessee, United States, 38104