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Table 5 Secondary endpoint analysis

From: Clinical and imaging outcomes after intrathecal injection of umbilical cord tissue mesenchymal stem cells in cerebral palsy: a randomized double-blind sham-controlled clinical trial

Outcome

UCT-MSC (n=36)

control (n=36)

Fractional anisotropy

Corticospinal tract

  

12 months mean (SD)

0.48 (0.04)

0.42 (0.06)

Mean changes from baseline (95% CI)

0.032 (0.02 to 0.03)

−0.007 (−0.010 to −0.002)

Difference vs control (95% CI)

0.055 (0.02 to 0.08)

–

Cohen’s d (95%CI)

0.81 (0.36 to 1.26)

–

Posterior thalamic radiate

  

12 months mean (SD)

0.37 (0.03)

0.32 (0.04)

Mean changes from baseline (95% CI)

0.024 (0.020 to 0.028)

−0.020 (−0.02 to −0.01)

Difference vs control (95% CI)

0.059 (0.3 to 0.8)

–

Cohen’s d (95%CI)

1.04 (0.68 to 1.41)

–

Mean diffusivity (×103)*

Corticospinal tract

  

12 months mean (SD)

0.93 (0.05)

1.00 (0.12)

Mean changes from baseline (95% CI)

−0.035 (−0.04 to −0.02)

0.040 (0.02 to 0.05)

Difference vs control (95% CI)

−0.07 (−0.11 to −0.02)

–

Cohen’s d (95%CI)

0.77 (0.26 to 1.28)

–

Posterior thalamic radiate

  

12 months mean (SD)

1.02 (0.07)

1.09 (0.19)

Mean changes from baseline (95% CI)

−0.045 (−0.05 to −0.03)

0.033 (0.01 to 0.05)

Difference vs control (95% CI)

−0.07 (−0.15 to −0.003)

–

Cohen’s d (95%CI)

0.55 (0.01 to 1.11)

–

  1. *The mean (SD) should be divided by 1000