Research Article

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 groupMedium-dose groupHigh-dose groupTotal ()
(%)Events (%)Events (%)Events (%)Events

Total adverse event3 (100.0%)130 (0.0%)02 (66.7%)25 (55.6%)15
 Nervous system disorders2 (66.7%)20 (0.0%)01 (33.3%)13 (33.3%)3
  Blood-brain barrier breakdowna,b1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
  Headache0 (0.0%)00 (0.0%)01 (33.3%)11 (11.1%)1
  Photopsia1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
 Gastrointestinal disorders1 (33.3%)20 (0.0%)01 (33.3%)12 (22.2%)3
  Constipation1 (33.3%)10 (0.0%)01 (33.3%)12 (22.2%)2
  Abdominal distension1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
 Investigations2 (66.7%)20 (0.0%)00 (0.0%)02 (22.2%)2
  Blood pressure increased1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
  Weight increased1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
 Infections and infestations1 (33.3%)20 (0.0%)00 (0.0%)01 (11.1%)2
  Herpes zoster1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
  Urinary tract infectiona1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
 Injury, poisoning and procedural complications1 (33.3%)20 (0.0%)00 (0.0%)01 (11.1%)2
  Fall1 (33.3%)10 (0.0%)00 (0.0%)01 (11.1%)1
  Rib fracture1 (33.3%)10 (0.0%)00 (0.0%)01 (11.11)1
 Psychiatric disorders1 (33.3%)20 (0.0%)00 (0.0%)01 (11.11)2
  Anxiety1 (33.3%)10 (0.0%)00 (0.0%)01 (11.11)1
  Depression1 (33.3%)10 (0.0%)00 (0.0%)01 (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).