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Table 3 Statistical evaluation of vocal fold function parameters

From: Treatment of vocal fold scarring with autologous bone marrow-derived human mesenchymal stromal cells—first phase I/II human clinical study

ParameterAll patients (n = 16)Patients treated with MSC only (n = 8) or MSC+hyaluronan (HA) (n = 8)Patients with smaller defects (n = 11)Patients with large defects (n = 5)
VHI (subjective voice handicap scale)T0, 83 (SD 19); T1, 66 (SD 25) (p = 0.04)MSC: T0,78 (SD 20.5); T1, 57 (SD 25.7) (p = 0.036)
MSC+HA: T0, 88 (SD 18); T1 76 (SD 23) (p = ns)
T0, 81 (SD 20); T1, 63 (SD 26) (p = 0.04)T0, 87 (SD 20); T1,73 (SD 26); ns
Phonation pressure threshold, PTP (cm H2O)T0, 6.0 (SD 1.3); T1, 4.7 (SD 1.2) (p = 0.0008)MSC: T0, 6.0 (SD 1.5); T1, 3.85 (SD 0.8) (p = 0.01)
MSC+HA: T0, 6.1 (SD 1.15); T1, 5.45 (SD 1.0) (p = 0.36)
T0, 6.2 (SD 1.5); T1, 4.6 (SD 1.4) (p = 0.003)T0, 5.5 (SD 0.7); T1, 4.8 (SD 0.5); ns
Maximum amplitude of glottal vibrations (U)T0, 1551 (SD 760); T1, 2270 (SD 982) (p = 0.0019)MSC: T0,1430 (SD 275); T1, 2006 (SD 440) (p = 0.03)
MSC+HA: T0, 1672 (SD 1068); T1, 2496 (SD 1280) (p = 0.03)
T0, 1751 (SD 767); T1, 2274 (SD 1074) (p = 0.01)T0, 1054 (SD 525); T1, 2261 (SD 882); ns (p = 0.07)
Open/closed quotient coefficient (%)T0, 75.4 (11.5); T1, 65.8 (15.3); nsMSC: T0, 72.7 (SD 8.5); T1, 67.2 (SD 11.1) (p = ns)
MSC+HA: T0, 75.2 (SD 15.5); T1, 68.8 (SD 20.6) (p = ns)
T0, 79.3 (7.5); T1, 68.3 (14.0) (p = 0.05)T0, 57.5 (9.2); T1, 67.5 (23)
ns
Glottal vibration parameters ratings (3 judges)10/16 patients improved, ns; or 12/16, including patients with improved glottal closure (p = 0.039)MSC: 5/8 patients improved, 3/8 decreased (but 2 of these showed improved glottal closure)
MSC+HA: 5/8 patients improved, 2/8 were unchanged, and 1/8 decreased
7/11 patients improved; or 8/11, including 1 patient with improved glottal closure3/5 patients improved; or 4/5, including 1 patient with improved glottal closure
  1. T0 preoperative, T1 1 year follow-up