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Table 4 Summary of Demographic Characteristics at Baseline

From: Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel®): preclinical and clinical trial in osteoarthritis of the knee joint

  Cohort 1 Cohort 2
Parameter 25 M (n = 10) 50 M (n = 10) P1 (n = 10) P value 75 M (n = 10) 150 M (n = 10) P2 (n = 10) P value
Age (years) 58.10 ± 8.23 57.30 ± 9.45 54.90 ± 8.27 0.73 55.00 ± 6.72 54.00 ± 6.73 56.70 ± 5.19 0.6
Female (n) 7 8 10 NA 8 5 7 NA
Male (n) 3 2 0 NA 2 5 3 NA
Height (cm) 156.85 ± 9.64 157.30 ± 12.23 152.25 ± 9.72 0.39 158.40 ± 8.86 158.88 ± 9.30 159.70 ± 10.67 0.9
Weight (kg) 73.10 ± 15.86 69.00 ± 14.62 66.10 ± 7.67 0.45 71.30 ± 9.09 66.00 ± 9.13 66.90 ± 8.57 0.39
BMI (kg/m2) 29.73 ± 6.09 27.74 ± 4.16 28.84 ± 4.91 0.76 28.38 ± 2.38 26.33 ± 4.48 26.40 ± 3.99 0.3
WOMAC total 1315.8 ± 444.8 1498.4 ± 407.4 1239.6 ± 472.2 0.28 1470.6 ± 471.0 1388.1 ± 508.8 1382.0 ± 324.7 0.9
ICOAP total 45.7 ± 19.2 59.3 ± 21.7 49.3 ± 18.7 0.38 58.4 ± 20.7 46.4 ± 22.0 54.8 ± 17.8 0.54
VAS 60.9 ± 19.7 73.7 ± 15.2 61.0 ± 23.8 0.24 57.4 ± 29.0 46.6 ± 23.6 65.3 ± 12.2 0.11
WORMS total score 67.0 ± 19.8 78.8 ± 40.9 76.5 ± 23.5 0.65 71.3 ± 21.4 62.0 ± 17.9 70.8 ± 14.7 0.48
Kellgren and Lawrence Grade 2 (n) 4 1 3 NA 1 3 2 NA
Kellgren and Lawrence Grade 3 (n) 6 9 7 NA 9 7 8 NA
  1. Values are shown as mean ± SD unless indicated otherwise
  2. 25 M, 50 M, 75 M, 150 M = 25, 50, 75, and 150 million cells, respectively
  3. P1, P2 = placebo 1 and placebo 2, respectively
  4. BMI body mass index, ICOAP intermittent and constant osteoarthritis pain, NA statistical comparisons for these groups have not been conducted due to too few samples, VAS visual analog scale, WOMAC Western Ontario and McMaster Universities