PMID- 27589225
OWN - NLM
STAT- MEDLINE
DCOM- 20170525
LR  - 20220330
IS  - 1537-2995 (Electronic)
IS  - 0041-1132 (Linking)
VI  - 56
IP  - 11
DP  - 2016 Nov
TI  - Continuous CD34+ cell collection by a new device is safe and more efficient than 
      by a standard collection procedure: results of a two-center, crossover, 
      randomized trial.
PG  - 2824-2832
LID - 10.1111/trf.13769 [doi]
AB  - BACKGROUND: Peripheral blood stem cells (PBSCs) collected from 
      granulocyte-colony-stimulating factor (G-CSF)-mobilized donors are routinely used 
      for hematopoietic stem cell transplantation. Most PBSC collections worldwide have 
      used the COBE Spectra (COBE) platform that is being replaced by the Spectra Optia 
      (OPTIA). This study compared the PBSC collection performance and safety of the 
      OPTIA using a single-step, continuous mononuclear cell (CMNC) collection 
      procedure and the standard COBE MNC procedure. STUDY DESIGN AND METHODS: A 
      prospective, noninferiority, randomized, open-label, crossover, multicenter study 
      was conducted in G-CSF-mobilized donors randomized to undergo MNC collection on 
      Days 5 and 6. The primary endpoint was CD34+ cell collection efficiency (CE1%) 
      with a noninferiority margin of 10%. The secondary endpoint was CD34+ cell CE2%. 
      Product purity and safety were also assessed. RESULTS: Twenty-three healthy 
      donors (87% male) participated in the study. Mean (+/-SD) CD34+ CE1% was 84.4% 
      (+/-16.4%) and 66.2% (+/-15.3%) for the OPTIA and COBE, respectively (p < 0.001 for 
      noninferiority and superiority). Mean (+/-SD) CD34+ CE2% was 62.4 (+/-11.6) and 48.4 
      (+/-11.2) for the OPTIA and COBE, respectively (p < 0.001 for superiority). 
      Granulocyte and platelet (PLT) contamination were lower in OPTIA-collected 
      products. There were no unexpected adverse events (AEs) and no significant 
      differences in the incidence of AEs between study arms. PLT loss was less with 
      the OPTIA than with the COBE. CONCLUSION: The OPTIA CMNC collection procedure is 
      safe and effective for the collection of CD34+ cells in G-CSF-mobilized donors 
      and was superior to the COBE for CE1% and CE2%, collecting approximately 19 and 
      16% higher, respectively.
CI  - (c) 2016 AABB.
FAU - Cancelas, Jose A
AU  - Cancelas JA
AD  - Hoxworth Blood Center, Cincinnati, Ohio.
FAU - Scott, Edward P
AU  - Scott EP
AD  - Key Biologics, LLC, Memphis, Tennessee.
FAU - Bill, Jerome R
AU  - Bill JR
AD  - TerumoBCT, Inc., Lakewood, Colorado.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160902
PL  - United States
TA  - Transfusion
JT  - Transfusion
JID - 0417360
RN  - 0 (Antigens, CD34)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antigens, CD34/*analysis
MH  - Cross-Over Studies
MH  - Female
MH  - Granulocyte Colony-Stimulating Factor
MH  - Hematopoietic Stem Cell Mobilization/methods
MH  - Humans
MH  - Leukapheresis/*instrumentation/methods
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Young Adult
EDAT- 2016/09/03 06:00
MHDA- 2017/05/26 06:00
CRDT- 2016/09/03 06:00
PHST- 2016/04/18 00:00 [received]
PHST- 2016/06/29 00:00 [revised]
PHST- 2016/07/01 00:00 [accepted]
PHST- 2016/09/03 06:00 [pubmed]
PHST- 2017/05/26 06:00 [medline]
PHST- 2016/09/03 06:00 [entrez]
AID - 10.1111/trf.13769 [doi]
PST - ppublish
SO  - Transfusion. 2016 Nov;56(11):2824-2832. doi: 10.1111/trf.13769. Epub 2016 Sep 2.