Table 2.

Adverse events that were observed in at least 1 subject during the 12-week follow-up period (all causalities)

	Low dose (n = 3)	High dose (n = 6)
	No. of subjects (%) [no. of events]	No. of subjects (%) [no. of events]
Before hUCB-MSC injection
Total	2 (66.7) [4]	5 (83.3) [5]
Ommaya site pain	0 [0]	2 (33.3) [2]
Procedural pain	1 (33.3) [1]	1 (16.7) [1]
Headache	1 (33.3) [2]	0 [0]
Device malfunction	0 [0]	1 (16.7) [1]
Enteritis	1 (33.3) [1]	0 [0]
Otolithiasis	0 [0]	1 (16.7) [1]
After hUCB-MSC injection
Total	3 (100.0) [21]	6 (100.0) [48]
Nervous system disorders
Headache	2 (66.7) [5]	5 (83.3) [12]
Paraesthesia	0 [0]	2 (33.3) [4]
Gastrointestinal disorders
Nausea	2 (66.7) [E2]	3 (50.0) [7]
Vomiting	1 (33.3) [2]	3 (50.0) [6]
Abdominal pain	0 [0]E	1 (16.7) [1]
Dyspepsia	1 (33.3) [1]	0 [0]
General disorders and administration site conditions
Fever	3 (100) [7]	6 (100) [13]
Chills	0 [0]	1 (16.7) [1]
Ommaya site pain	1 (33.3) [1]	0 [0]
Pain other than the Ommaya site	0 [0]	1 (16.7) [1]
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness	0 [0]	1 (16.7) [1]
Myalgia	1 (33.3) [2]	0 [0]
Arthralgia	0 [0]	1 (16.7) [1]
Periarthritis	0 [0]	1 (16.7) [1]
Infections and infestations
Impetigo	1 (33.3) [1]	0 [0]
Psychiatric disorders
Delusion	0 [0]	0 [0]