Published clinical experiences of cell treatments of anal fistula (Part 2)

Table 2: Published clinical experiences of cell treatments of anal fistula (Part 2). An update of the tables taken from the section “Stem Cell Application in Fistula Disease” [33].

Investigator	Intervention model	Masking	Procedure	Enrolled	Number of treated patients	Healed	Follow up (months)	Recurrence	SAE
García-Olmo et al. [34]	Single arm	Open label	Closure of IO. Without fibrin glue. Injection in site	1	1	1	3	0	0
García-Olmo et al. [41]	Single arm	Open label	Cells resuspended in fibrin glue. Injection in site	9	9	6 (66%)	12	Not specified	0
García-Olmo et al. [25]	Two arms: fibrin glue, fibrin glue + ASCs	Open label	Closure of IO. Injection in site	50 (35 with Crohn's disease)	Fibrin glue: 25	Fibrin glue: 3	12	Fibrin glue: 0	4 (only one related to fibrin glue, others not related)
García-Olmo et al. [25]	Two arms: fibrin glue, fibrin glue + ASCs	Open label	Closure of IO. Injection in site	50 (35 with Crohn's disease)	Fibrin glue + ASCs: 24	Fibrin glue + ASCs: 17 (70%)	12	Fibrin glue + ASCs: 2	4 (only one related to fibrin glue, others not related)
García-Olmo et al. [40]	Single arm	Open label	Closure of IO. Without fibrin glue. Injection in site	1	1	1	36	1	0
Ciccocioppo et al. [39]	Single arm	Open label	Four injections in site	12	10	7 (70%)	12	0	0
Herreros et al. [27]	Three arms: fibrin glue, ASCs, fibrin glue + ASCs	Double blind (subject, outcomes assessor)	Closure of IO. Injection in site	214	ASCs: 64	ASCs: 27 (42%)	6	ASCs: 0	4 unrelated to study treatment
					Fibrin glue + ASCs: 60	Fibrin glue + ASCs: 24 (40%)		Fibrin glue + ASCs: 4
					Fibrin glue: 59	Fibrin glue: 23		Fibrin glue: 0
Herreros et al. [27]	Three arms: fibrine, ASCs, fibrin glue + ASCs	Double blind (subject, Outcomes Assessor)	Closure of IO. Injection in site	135	Not specified	ASCs: 57%	12	Not specified	1 unrelated to study treatment
						Fibrin glue+ ASCs: 52.4%
						Fibrin glue: 37.3%
Guadalajara et al. [42]	Two arms: fibrin glue, fibrin glue + ASCs	Open label	Closure of IO. Injection in site	34	Fibrin glue: 13	Fibrin glue: 3	38	Fibrin glue: 1	0
Guadalajara et al. [42]	Two arms: fibrin glue, fibrin glue + ASCs	Open label	Closure of IO. Injection in site	34	Fibrin glue + ASCs: 21	Fibrin glue + ASCs: 10 (47%)	38	Fibrin glue + ASCs: 5	0
Borowski et al. [35]	Single arm	Open label	Flap + Injection in site	3	3	3	3	0	0
de la Portilla et al. [37]	Single arm	Open label	Closure of IO. Without fibrin glue. Injection in site	34	24	9 (37%)	4	Not specified	2 unrelated to study treatment
Cho et al. [38]	Single arm: Dose escalation study	Open label	Closure of IO. Fibrin glue. Injection in site	10	9	3 (33%)	8	0	0
Lee et al. [36]	Single arm	Open label	Closure of IO. Fibrin glue. Injection in site	50	43	27 (62%)	12	3	1 unrelated to study treatment
Cho et al. [43]	Single arm	Open label	Closure of IO. Fibrin glue. Injection in site	41	41	26 (63%)	24	5	0
Ciccocioppo et al. [44]	Single arm	Open label	Four injections in site	8	8	2 (25%)	72	0	0
García-Olmo et al. [45]	Single arm	Open label	Flap + Injection in site	10	10	6 (60%)	12	0	0
Molendijk et al. [24]	Four arms: control group, ASCs different dose	Double blind	Closure of IO. Injection in site	21	15	7 (46%)	6	Not specified	0
Borowski et al. [46]	Single arm	Open label	Closure of IO. Injection in site	7	7	5 (71%)	46	1	1 unrelated to study treatment
Park KJ. [47]	Two arms: ASCs different dose	Open label	Injection in site	6	6	3	8	0	0