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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
  1. 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