Table 1.
1A: Analysis of Sepax Clinical Separations
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TNC | TRC | %TNC Rec | %TRC Depl | Total ISHAGE CD34+ | % Lymph | % Mono | % Gran | |
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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 |
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1B: Analysis of Final Product Doses - 1/3 patients received placebo in place of cells‡
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TIME/Late-TIME Products | FOCUS Products | |||||||
TNC Dose | Total RBC Dose | TNC Dose | Total RBC Dose | |||||
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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.