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Table 2 Summary of demography and baseline characteristics

From: Safety, tolerability and efficacy of intra-articular Progenza in knee osteoarthritis: a randomized double-blind placebo-controlled single ascending dose study

 

Placebo

(n = 4)

PRG 3.9M

(n = 8)

PRG 6.7M

(n = 8)

Demographics

 Age (years)

55.0 ± 10.42

50.8 ± 7.29

55.0 ± 5.15

 Females

3 (75%)

2 (25%)

3 (37.5%)

 Height (cm)

165.0 ± 7.87

172.6 ± 10.99

174.4 ± 11.99

 Weight (kg)

69.8 ± 11.55

82.9 ± 12.44

81.9 ± 14.23

 BMI (kg/m2)

25.5 ± 2.84

27.7 ± 2.05

26.8 ± 2.98

OA characteristics

 Study knee KL OA grade 1

1 (25%)

0 (0%)

1 (12.5%)

 Study knee KL OA grade 2

0 (0%)

2 (25%)

1 (12.5%)

 Study knee KL OA grade 3

3 (75%)

6 (75%)

6 (75%)

 OA in non-study knee

3 (75%)

7 (87.5%)

6 (75%)

Patient-reported outcomes

 VAS pain score (0–100 mm)

43.8 ± 7.41

57.0 ± 13.82

60.8 ± 13.01

 WOMAC pain score (0–20)

6.3 ± 3.86

6.6 ± 2.07

7.9 ± 3.04

 WOMAC stiffness score (0–8)

3.3 ± 2.06

3.4 ± 1.19

4.1 ± 1.89

 WOMAC physical functioning score (0–68)

16.7 ± 10.69

22.0 ± 9.80

26.8 ± 10.20

 AQoL-4D utility score

0.75 ± 0.213

0.80 ± 0.140

0.76 ± 0.183

Activity level (FitBit®; n = 18)

 Average daily steps

11,071 ± 7085

9049 ± 2605

11,934 ± 12,013

Quantitative MRI assessments

 Cartilage volume (mm3)

  Medial tibial region

1597.1 ± 642.95

2037.0 ± 665.59

2166.0 ± 858.29

  Lateral tibial region

1777.5 ± 532.24

2459.3 ± 836.59

2470.3 ± 784.52

  Patella

2588.3 ± 965.59

2895.2 ± 1204.61

3637.1 ± 1431.01

 Tibial bone area (mm2)

  Medial region

2045.9 ± 374.36

2567.4 ± 388.86

2727.2 ± 632.68

  Lateral region

1508.3 ± 364.83

1641.3 ± 368.14

1611.9 ± 582.25

 Bone marrow lesions

  Medial tibiofemoral region

1 (25%)

4 (50%)

8 (100%)

  Lateral tibiofemoral region

1 (33.3%)

4 (50%)

2 (25%)

  Patella

2 (50%)

3 (37.5%)

1 (12.5%)

 Cartilage defects

  Medial tibiofemoral region

3 (75%)

8 (100%)

7 (100%)*

  Lateral tibiofemoral region

4 (100%)

8 (100%)

7 (100%)*

  Patella

3 (75%)

6 (75%)

6 (85.7%)

Biomarkers

 Urine CTX-II (ng/mmol)

336.8 ± 311.34

149.9 ± 44.45

230.9 ± 136.69

 Urine C2C (ng/mmol)

1591.6 ± 715.73

2388.9 ± 1616.07

1049.0 ± 1026.84

 Serum HA (ng/mL)

32.6 ± 6.32

49.7 ± 19.95

47.0 ± 24.05

 Serum MIF (ng/mL)

12.9 ± 3.32

13.2 ± 5.34

15.5 ± 2.86

 Serum CTX-I (ng/mL)

0.3 ± 0.08

0.3 ± 0.15

0.4 ± 0.10

  1. Data are presented as the mean ± SD or n (%). Baseline data from semi-quantitative analysis of MRI scans, conducted using the MRI osteoarthritis knee score (MOAKS) methodology are provided in Additional file 1: Table S1
  2. AQoL-4D, assessment of quality of life 4D questionnaire; BMI, body mass index; C2C, type II collagen C2C peptide; CTX-I, C-terminal telopeptide of type I collagen; CTX-II, C-terminal telopeptide of type II collagen; HA, hyaluronic acid; KL, Kellgren–Lawrence; MIF, macrophage migration inhibitory factor; VAS, visual analogue scale; WOMAC Western Ontario McMaster Universities Arthritis Index
  3. * Missing double echo steady state (DESS) sequence in 1 patient