Clinical trials using mesenchymal stem cells in liver diseases and inflammatory bowel diseases

Tsuchiya, Atsunori; Kojima, Yuichi; Ikarashi, Shunzo; Seino, Satoshi; Watanabe, Yusuke; Kawata, Yuzo; Terai, Shuji

doi:10.1186/s41232-017-0045-6

Inflammation and Regeneration

Table 2 Clinical trials in inflammatory bowel diseases

From: Clinical trials using mesenchymal stem cells in liver diseases and inflammatory bowel diseases

No.	Start year	Cell source	Autologous/allogeneic	Administration route	Number of cells infused	Diseases	Number of patients	Follow-up period	Phase	Study design	ClinicalTrials.gov identifier	Status	Result	References
1	2006	Bone marrow	Allogeneic	Peripheral vein	8 × 106 cells/kg, 2 times or 2 × 106 cells/kg, 2 times	Crohn’s disease	10	4 weeks	Phase 2	Randomized, parallel assignment, open label	NCT00294112	Completed
2	2007	Bone marrow	Allogeneic	Peripheral vein	Total of 6 × 108 cells/patient, 4 times or total of 12 × 108 cells/patient, 4 times	Crohn’s disease	98	24 weeks	Phase 3	Randomized, parallel assignment, double blind	NCT00543374	Completed
3	2010	Adipose tissue	Autologous	Unknown	Unknown	Fistulizing Crohn’s disease	15	3 years	Phase 1–2	Non-randomized, single group assignment, open label	NCT01157650	Completed
4	2015	Umbilical cord	Allogeneic	Peripheral vein	Unknown	Crohn’s disease	32	1 year	Phase 1–2	Randomized, parallel assignment, open label	NCT02445547	Completed
5	2012	Bone marrow	Allogeneic	Peripheral vein	2 × 108 cells/patient, more than 4 times	Crohn’s disease	11	4 weeks	Phase 1–2	Non-randomized, single group assignment, open label	NCT01510431	Completed
6	2010	Bone marrow	Allogeneic	Peripheral vein	2 × 106 cells/kg, 4 times	Crohn’s disease	15	6 weeks	Phase 2	Non-randomized, single group assignment, open label	NCT01090817	Completed	Improvement in CDAI, AQoL score. Decrease in CRP. Endoscopic improvement	24
7	2012	Bone marrow	Autologous	Peripheral vein	2 × 106 cells/kg, 5 × 106 cells/kg, or 1 × 107 cells/kg	Crohn’s disease	16	1 year	Phase 1	Non-randomized, single group assignment, open label	NCT01659762	Completed
8	2010	Bone marrow	Allogeneic	Intralesional	1 × 107 cells/patient, 3 × 107 cells/patient, or 9 × 107 cells/patient	Fistulizing Crohn’s disease	21	12 weeks	Phase 1–2	Randomized, parallel assignment, double blind	NCT01144962	Completed	Local treatment with MSCs showed promotion of fistula healing. Lower MSC dose seemed superior.	25
9	2009	Adipose tissue	Autologous	Intralesional	3 × 107 cells/patient (in the event of incomplete closure at 8 weeks, a second injection was given that contained 1.5 times more cells than the f irst)	Fistulizing Crohn’s disease	43	8 weeks	Phase 1	Non-randomized, single group assignment, open label	NCT00992485	Completed	Local treatment with MSCs showed promotion of fistula healing.	26
10	2010	Adipose tissue	Allogeneic	Intralesional	2 × 107 cells/patient (in the event of incomplete closure at 12 weeks, an additional 4 × 107 cells were administered)	Fistulizing Crohn’s disease	24	24 weeks	Phase 1–2	Non-randomized, single group assignment, open label	NCT01372969	Completed	Local treatment with MSCs showed promotion of fistula healing.	27
11	2009	Adipose tissue	Autologous	Intralesional	1 × 107 cells/patient, 2 × 107 cells/patient, or 4 × 107 cells/patient	Fistulizing Crohn’s disease	10	4 weeks	Phase 1	Non-randomized, single group assignment, open label	NCT00992485	Completed	Local treatment with MSCs showed promotion of fistula healing. All patients with complete healing showed a sustained effect.	28
12	2009	Adipose tissue	Allogeneic	Intralesional	2 × 107 cells/patient (in the event of incomplete closure at 12 weeks, an additional 4 × 107 cells were administered)	Fistulizing Crohn’s disease	10	12 weeks	Phase 1–2	Non-randomized, single group assignment, open label	NCT00999115	Completed	Local treatment with MSCs showed promotion of fistula healing; 60% of patients achieved complete healing.	29
13	2009	Adipose tissue	Autologous	Intralesional	1 × 107 cells/cm²	Fistulizing Crohn’s disease	43	8 weeks	Phase 2	Non-randomized, single group assignment, open label	NCT01011244	Completed	In most cases, complete closure after initial treatment was well-sustained over a 24-month period.	30
14	2007	Bone marrow	Allogeneic	Peripheral vein	Total of 6 × 108 cells/patient, 4 times or total of 1.2 × 109 cells/patient, 4 times	Crohn’s disease	330	4 weeks	Phase 3	Randomized, parallel assignment, double blind	NCT00482092	Active
15	2012	Adipose tissue	Allogeneic	Intralesional	1.2 × 108 cells/patient	Fistulizing Crohn’s disease	212	24 weeks	Phase 3	Randomized, parallel assignment, double blind	NCT01541579	Active	Local treatment with MSCs showed promotion of fistula healing.	31
16	2010	Bone marrow	Allogeneic	Peripheral vein	2 × 10^8 cells/patient, 3 times	Crohn’s disease	120	180 days	Phase 3	Non-randomized, single group assignment, open label	NCT01233960	Active
17	2015	Adipose tissue	Autologous	Intralesional	Unknown	Fistulizing Crohn’s disease	10	62 weeks	Phase 2	Non-randomized, single group assignment, open label	NCT02403232	Recruiting
18	2013	Bone marrow	Autologous	Intralesional	Unknown	Fistulizing Crohn’s disease	10	16 weeks	Phase 1	Randomized, parallel assignment, single blind	NCT01874015	Recruiting
19	2015	Adipose tissue	Allogeneic	Peripheral vein	5 × 107 cells/patient, 7.5 × 107 cells/patient, or 1 × 108 cells/patient	Crohn’s disease	9	4 weeks	Phase 1	Non-randomized, single group assignment, open label	NCT02580617	Recruiting
20	2013	Umbilical cord	Allogeneic	Peripheral vein	5 × 107 cells/patient or 1 × 108 cells/patient	Crohn’s disease	24	12 weeks	Phase 1–2	Non-randomized, single group assignment, open label	NCT02000362	Recruiting
21	2013	Adipose tissue	Autologous	Intralesional	2 × 107 cells/patient	Fistulizing Crohn’s disease	20	2–24 months	Phase 1	Non-randomized, single group assignment, open label	NCT01915927	Recruiting
22	Unknown	Bone marrow	Autologous	Peripheral vein	1–2 × 106 cells/kg	Crohn’s disease	10	6 weeks	Phase 1	Unknown	–	–	Three patients showed clinical response (decrease in CDAI).Three patients required surgery due to disease worsening.	32
23	2016	Bone marrow	Allogeneic	Intralesional	2 × 107 cells/patient	Fistulizing Crohn’s disease	20	7, 10, 16 months	Phase 1	Non-randomized, single group assignment, open label	NCT02677350	Not yet recruiting
24	2015	Umbilical cord	Allogeneic	Peripheral vein	1 × 106 cells/kg, 3 times	Ulcerative colitis	30	24 weeks	Phase 1–2	Randomized, parallel assignment, single blind	NCT02442037	Recruiting
25	2015	Adipose tissue	Allogeneic	Through a colonoscope	6 × 107 cells/patient	Ulcerative colitis	8	12 weeks	Phase 1–2	Non-randomized, single group assignment, open label	NCT01914887	Unknown
26	2015	Umbilical cord	Allogeneic	First: peripheral vein, second: superior mesenteric artery	First: 3.8 ± 1.6 × 107 cells/patient, second: 1.5 × 107 cells/patient	Ulcerative colitis	80	12 weeks	Phase 1–2	Non-randomized, single group assignment, open label	NCT01221428	Unknown	Decrease in the median Mayo score and histology score. Improvement in IBDQ scores.	33

CD Crohn’s disease, CDAI Crohn’s Disease Activity Index, AQoL The Assessment of Quality of Life, CRP C-reactive protein, IBDQ Inflammatory Bowel Disease Questionnaire

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