An Evaluation of the Spectra Optia CMNC Collection Procedure

Terumo

Status: Completed

Conditions: Mononuclear (MNC) Cell Donors; Healthy Apheresis Donors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02253160

CTS-5038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

Spectra Optia CMNC first, then COBE Spectra MNC

Experimental group

Description:

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

Treatment:

Device: COBE Spectra MNC

Drug: Granulocyte-colony stimulating factor (G-CSF)

Device: Spectra Optia CMNC

COBE Spectra MNC first, then Spectra Optia CMNC

Experimental group

Description:

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

Treatment:

Device: COBE Spectra MNC

Drug: Granulocyte-colony stimulating factor (G-CSF)

Device: Spectra Optia CMNC