Phase I Trial of Intra-arterial Administration of Autologous Bone Marrow-Derived Mesenchymal Stem Cells in Patients with Multiple System Atrophy
Table 2
Profiles of adverse events in study participants.
Low-dose group
Medium-dose group
High-dose group
Total ()
(%)
Events
(%)
Events
(%)
Events
(%)
Events
Total adverse event
3 (100.0%)
13
0 (0.0%)
0
2 (66.7%)
2
5 (55.6%)
15
Nervous system disorders
2 (66.7%)
2
0 (0.0%)
0
1 (33.3%)
1
3 (33.3%)
3
Blood-brain barrier breakdowna,b
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Headache
0 (0.0%)
0
0 (0.0%)
0
1 (33.3%)
1
1 (11.1%)
1
Photopsia
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Gastrointestinal disorders
1 (33.3%)
2
0 (0.0%)
0
1 (33.3%)
1
2 (22.2%)
3
Constipation
1 (33.3%)
1
0 (0.0%)
0
1 (33.3%)
1
2 (22.2%)
2
Abdominal distension
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Investigations
2 (66.7%)
2
0 (0.0%)
0
0 (0.0%)
0
2 (22.2%)
2
Blood pressure increased
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Weight increased
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Infections and infestations
1 (33.3%)
2
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
2
Herpes zoster
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Urinary tract infectiona
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Injury, poisoning and procedural complications
1 (33.3%)
2
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
2
Fall
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.1%)
1
Rib fracture
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.11)
1
Psychiatric disorders
1 (33.3%)
2
0 (0.0%)
0
0 (0.0%)
0
1 (11.11)
2
Anxiety
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.11)
1
Depression
1 (33.3%)
1
0 (0.0%)
0
0 (0.0%)
0
1 (11.11)
1
All the terminologies of medical signs, symptoms, and disorders were coded as MedDRA (ICH, v22.1). aSerious adverse event. bAdverse drug reaction (i.e., adverse event attributable to the MSCs treatment).
