Table 1.
Trial inclusion and exclusion criteria.
Fig 1.
Consort flow diagram for clinical trial (EudraCT number 2017-005065-47).
Table 2.
Trial design and schedule of events.
Table 3.
Baseline patient demographics and clinical characteristics.
Table 4.
Patient characteristics.
Fig 2.
Post-injection plasma ILB® levels for individual patients at Day 1 and Day 29.
Table 5.
Plasma ILB® and Hepatocyte Growth Factor (HGF) levels at Day 8 and Day 29 injections (N = 13; Mean ± SD).
Fig 3.
Post-injection changes in plasma HGF levels in individual patients after the Day 29 injection of ILB®.
Table 6.
Adverse event data (TEAE = treatment related adverse events; SAE = serious adverse events; N = Number of patients; M = number of events).
Fig 4.
Post-injection changes in activated partial thromboplastin time (APTT) after the Day 29 injection of ILB®.
Fig 5.
Changes in the (A) ALSFRS-R, (B) Norris and (C) autonomic/sensory symptom scores from baseline (N = 13; Mean ± SD).
A rising ALSFRS-R and Norris score indicates functional improvement. Conversely, a falling autonomic/sensory symptom score indicates symptom improvement.
Table 7.
Comparison of actual and expected (predicted by GLM and preslope models) ALSFRS-R scores for individual patients at Visit 2 (V2 at Day 1; prior to first ILB® injection), Visit 7 (V7 at Day 36; 7 days after last ILB® injection) and Visit 10 (V10 at Day 99; 70 days after last ILB® injection); (N/A = data not available).
Table 8.
Autonomic and sensory scores for individual patients.
Table 9.
Clinical and laboratory measurements of patients with ALS (N = 13; Mean±SD; ns = not significant; nd = not determined; * = evidence of subgroup responsiveness).