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. Author manuscript; available in PMC: 2013 Oct 1.
Published in final edited form as: Transfusion. 2012 Feb 10;52(10):2225–2233. doi: 10.1111/j.1537-2995.2011.03543.x

Table 1.

Tables 1A and 1B

1A: Analysis of Sepax Clinical Separations
TNC TRC %TNC Rec %TRC Depl Total ISHAGE CD34+ % Lymph % Mono % Gran

Mean 5.51×108 1.85×109 23.6 100.0 3.33×106 42.4 9.2 38.0
Std Dev 3.21×108 2.65×109 5.9 0.0 1.65×106 17.2 9.3 15.6
Median 4.83×108 1.34×109 23.7 100.0 3.06×106 42.5 8.0 39.0
Range 0.094*–18.3×108 0.032*–4.0×1010 0.7*–39.7 99.9*–100.0 0.021*–10×106 0–95.0 0–112.7 0–78.0

1B: Analysis of Final Product Doses - 1/3 patients received placebo in place of cells
TIME/Late-TIME Products FOCUS Products
TNC Dose Total RBC Dose TNC Dose Total RBC Dose

N = 177 177 92 92
Mean 1.47×108 1.92×109 9.94×107 3.72×108
Std Dev 1.55×107 1.75×1010 4.55×106 2.21×108
Median 1.50×108 4.58×108 1.00×108 3.09×108
Range 0.036 – 1.50×108 0.017 – 23.3×1010 0.61 – 1.01×108 0.13 – 1.58×109
*

Lower value represents cells recovered after a Sepax device failure. Cells were recovered manually from the Sepax.

Lower values represent out of range results obtained from automated counters

Products were prepared for all recipients. Randomization to active or placebo arm occurred following product preparation. Results shown are for all products prepared.