An Evaluation of the Spectra Optia CMNC Collection Procedure
Healthy Apheresis Donors · Mononuclear (MNC) Cell Donors
Bottom Line
View on ClinicalTrials.gov: NCT02253160 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spectra Optia CMNC (Device); COBE Spectra MNC (Device); Granulocyte-colony stimulating factor (G-CSF) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CD34+ Collection Efficiency (CE1 %) |
87.7; 81.4; 66.6; 65.8 | — |
| SECONDARY CD34+ Collection Efficiency (CE2 %) |
64.7; 59.6; 47.0; 50.2 | — |
| SECONDARY MNC Collection Efficiency (CE1%) |
62.06; 63.75; 45.46; 48.58 | — |
| SECONDARY CD34+ Per kg of Body Weight |
5.14; 3.75; 3.50; 3.68 | — |
| SECONDARY MNC Product Contamination/Purity (%) - Hematocrit (%) |
6.1; 3.7; 4.5; 5.7 | — |
| SECONDARY MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL) |
51.689; 63.338; 83.792; 70.944 | — |
| SECONDARY MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL) |
3724.9; 2022.9; 2857.4; 3736.0 | — |
| SECONDARY MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %) |
28.7; 23.5; 27.9; 30.3 | — |
| SECONDARY MNC Blood Product Volume (mL) |
144.8; 141.3; 140.8; 137.7 | — |
| SECONDARY Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL) |
32.5; 8.7; 147.5; 179.3 | — |
| SECONDARY Procedure Time (Minutes) |
153.8; 151.4; 151.1; 146.7 | — |
| SECONDARY MNC Collection Efficiency (CE2%) |
50.99; 52.98; 37.77; 39.72 | — |
| SECONDARY MNC Product Contamination/Purity - RBC Concentration (10^6/µL) |
1.029; 0.526; 0.653; 0.857 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- ≥ 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02253160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.