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Table 2 Summary of Patients data, and Results for Vocal Fold function parameters, Pressure data and Patient’s subjective ratings preoperative and after at 1 year

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

Patient

Group (vocal fold damage)

Treatment: MSC or MSC+hyaluronan (HA) (unilateral or bilateral)

Side effects: SAE (systemic reaction, airway problem, infection); minor (e.g., fold edema, laryngitis)

Age, sex

Voice Handicap Index (pre/postop 0–120) (*VHI change ≥ 13 points decrease = sign. Improvement)

Vocal fold vibration qualitative ratings (pre/postop): mucosal wave, vibration amplitude, glottal closure

Vocal fold vibration, computerized analysis (pre/postop) (normalized U)

Phonation pressure threshold: PTP (cm H2O) (pre/postop) **decrease ≥ 0.5 cm = positive change

Max. area variations (increase = positive), glottal closure (decrease = positive), open/closed coefficient (%) (decrease = positive)

1

Scar+defect (uni)

MSC, uni

None

66, male

53/24*

Improved

1732/2146, 49/0, 78/68, improved

5.5/4.7**

2

Severe scar (bilat)

MSC, bilat

None

53, male

86/53*

Improved

7.8/4.1**

3

Sulcus+scar (bilat)

MSC, uni

None

57, female

78/74

Decreased, Gl. closure improved

1723/2021, 107/40, 82/71, improved

6.4/4.0**

4

Scar+defect (uni)

MSC, uni

None

50, male

65/74

Improved

1432/2124, 76/84, 68/74, unchanged

4.0/2.7**

5

Scar (bilat)

MSC, bilat

None

71, male

93/61*

Improved

1290/1476, 0/0, 75/59, improved

4.3/2.8**

6

Scar (uni) large defect

MSC+HA, uni

None

55, male

103/104

Improved

5.4/5.5

7

Scar (uni) large defect

MSC+HA, uni

None

70, male

59/69

Improved

633/1357, 139/11, 64/78, improved

4.9/5.0

8

Scar (uni) large defect

MSC+HA, uni

None

58, male

80/87

Unchanged

1498/3278, 209/540, −, unchanged

4.8/4.4

9

Scar severe (bilat)

MSC, bilat

None

74, male

89/85

Decreased

–, 740/1262,–, decreased

8.3/3.5**

10

Scar (uni) large defect

MSC, uni

None

48, female

109/72*

Decreased, Gl. closure improved

1517/2692, 942/553, 58/50, improved

5.7/4.7**

11

Sulcus+scar bilat

MSC+HA, uni

None

42, female

105/51*

Unchanged

2430/3249, 0/0, 88/37, improved

6.6/5.8**

12

Sulcus+scar (bilat)

MSC+HA, uni

None

45, female

113/92*

Improved

1761/1973, 2/0, 79/65, improved

5.9/5.6

13

Sulcus+scar bilat

MSC+HA, uni

None

51, male

74/82

Decreased

3602/4691, 3/59, 76/77, unchanged

6.0/5.3**

14

Scar (uni) large defect

MSC+HA, uni

None

48, female

85/35*

Improved

566/1716, 0/0, 51/47, improved

6.5/4.4 **

15

Sulcus+scar (bilat)

MSC, uni

None

43, male

50/13*

Improved

931/1579, 50/0, 75/81, improved

5.7/4.3**

16

Sulcus+scar (bilat)

MSC+HA, uni

None

30, male

86/87

Improved

1216/1210, 439/19, 93/81, improved

8.4/7.6**

  1. Patient 2 had a tracheostomy due to extensive scarring with fixation of cricoarytenoid joints. One patient (no. 9) smoked, and 1 patient suffered several cardiac infarctions the last 2 years previously (no. 5)