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Table 5 Quantitative MRI results: change from screening to month 12 in tibial cartilage volume and bone area

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)

Placebo – PRG 3.9M

Placebo – PRG 6.7M

Lateral tibial cartilage volume, mm3

− 95.4

(− 172.6, − 18.2)

p = 0.019

11.1

(− 37.1, 59.3)

p = 0.628

− 78.0

(− 125.9, − 30.1)

p = 0.004

106.5

(13.6, 199.4)

p = 0.028

17.4

(− 74.6, 109.4)

p = 0.690

Lateral tibial cartilage volume, % change

− 5.0

(− 8.8, − 1.3)

p = 0.012

0.4

(− 2.0, 2.7)

p = 0.730

− 3.5

(− 5.8, − 1.2)

p = 0.006

5.4

(0.9, 9.9)

p = 0.022

1.5

(− 2.9, 6.0)

p = 0.475

Medial tibial cartilage volume, mm3

− 15.4

(− 166.8, − 136.0)

p = 0.830

− 30.3

(− 141.2, 80.5)

p = 0.567

− 73.8

(− 186.1, 38.6)

p = 0.181

− 14.9

(− 203.2, 173.4)

p = 0.868

− 58.3

(− 250.6, 133.9)

p = 0.526

Medial tibial cartilage volume, % change

− 1.7

(− 8.8, 5.3)

p = 0.607

− 1.5

(− 6.7, 3.6)

p = 0.532

− 3.5

(− 8.7, 1.8)

p = 0.178

0.2

(− 8.6, 9.0)

p = 0.964

− 1.7

(− 10.7, 7.2)

p = 0.685

Lateral tibial bone area, mm2

− 10.0

(− 70.9, 50.9)

p = 0.730

− 8.5

(− 54.4, 37.4)

p = 0.698

25.6

(− 71.6, 20.4)

p = 0.253

1.5

(− 74.7, 77.7)

p = 0.967

− 15.6

(− 92.1, 60.9)

p = 0.669

Lateral tibial bone area, % change

− 0.2

(− 4.0, 3.6)

p = 0.906

− 0.2

(− 3.1, 2.7)

p = 0.888

− 2.0

(− 4.9, 0.9)

p = 0.158

0.0

(− 4.8, 4.8)

p = 0.993

− 1.8

(− 6.6, 3.0)

p = 0.436

Medial tibial bone area, mm2

30.4

(− 41.6, 102.4)

p = 0.381

50.3

(1.1, 99.6)

p = 0.046

− 17.0

(− 68.1, 34.1)

p = 0.487

20.0

(− 68.6, 108.5)

p = 0.636

− 47.4

(− 140.4, 45.6)

p = 0.293

Medial tibial bone area, % change

1.4

(− 1.6, 4.3)

p = 0.336

2.0

(− 0.0, 4.0)

p = 0.051

− 1.0

(− 3.1, 1.1)

p = 0.326

0.6

(− 3.0, 4.3)

p = 0.712

− 2.4

(− 6.2, 1.4)

p = 0.205

  1. Increase in cartilage volume = improvement; Increase in bone area = worsening