Table 3.
MSC-based clinical trials for inflammatory bowel disease.
| ClinicalTrials.gov identifier | Status | Phase | Estimated Enrollment | Pathway | Dosage | Conditions | Type of cells | Country |
|---|---|---|---|---|---|---|---|---|
| NCT03299413 | Active, not recruiting | Phase 1 Phase 2 |
20 | i.v. | 1.2×109 cells | IBD | Wharton Jelly mesenchymal stem cells |
Jordan |
| NCT03115749 | Not yet recruiting | n/a | 60 | n/a | n/a | IBD | Intestinal mesenchymal stem stells | Montpellier |
| NCT01914887 | Recruiting | Phase 1 Phase 2 |
8 | Colonoscope | 6×107 cells | UC | Allogeneic adipose tissue-derived mesenchymal stem cells |
Spain |
| NCT01874015 | Recruiting | Phase 1 | 10 | n/a | n/a | CD | Bone marrow mesenchymal stem cell | Spain |
| NCT01157650 | Completed | Phase 1 Phase 2 |
15 | n/a | n/a | CD | Autologous mesenchymal stem cells | United States |
| NCT00294112 | Completed | Phase 2 | 10 | i.v. | 8×106/2×106 cells | CD | Adult human mesenchymal stem cells | United States |
| NCT02677350 | Withdrawn | Phase 1 | 20 | i.v. | 2×107 cells | CD | Allogeneic bone marrow derived human mesenchymal stem cells | United States |
| NCT02445547 | Completed | Phase 1 Phase 2 |
82 | i.v. | 1×106 cell/kg | CD | Umbilical cord mesenchymal stem cells | China |
| NCT00543374 | Completed | Phase 3 | 98 | i.v. | 6×108-1.2×109 cells | CD | PROCHYMAL adult human mesenchymal stem cells | United States |
| NCT00482092 | Completed | Phase 3 | 330 | i.v. | 6×108-1.2×109 cells | CD | Mesenchymal stem cells | United States |
| NCT01540292 | Unknown status | Phase 1 Phase 2 |
20 | i.v. | 1.5-2.0 × 106 cell/kg | CD | Mesenchymal stem cell | Belgium |
| NCT04519671 | Recruiting | Phase 1 Phase 2 |
20 | i.v. | 7.5×107 cells | CD | Bone marrow derived mesenchymal stem cells | United States |
| NCT04519684 | Recruiting | Phase 1 Phase 2 |
20 | i.v. | 7.5×107 cells | CD | Bone marrow derived mesenchymal stem cells | United States |
| NCT01144962 | Completed | Phase 1 Phase 2 |
21 | Local injection | 1×107-9×107 cells | CD | Bone marrow derived mesenchymal stem cells | United States |
| NCT04519697 | Recruiting | Phase 1 Phase 2 |
20 | Local injection | 7.5×107 cells | CD | Mesenchymal stem cells | Netherlands |
| NCT04073472 | Not yet recruiting | Phase 1 | 15 | Local injection | 6×107 cells | CD | Bone marrow derived mesenchymal stem cells | United States |
| NCT04548583 | Recruiting | Phase 1 Phase 2 |
24 | Targeted endoscopic | 1.5×108-3×108 cells | CD | Bone marrow derived mesenchymal stem cells | United States |
| NCT03183661 | Enrolling by invitation | phase 1 | 9 | i.v. | 2×106/8×106 cell/kg | CD | Allogenic adipose-derived mesenchymal stem cells | China |
| NCT01221428 | Unknown | Phase 1 Phase 2 |
50 | i.v. | 2×107 cells | UC | Umbilical cord mesenchymal stem cells | Austria |
| NCT01541579 | Completed | Phase 3 | 278 | Local injection | 1.2×108 cells | CD | Adipose-derived stem cells | Austria |
| NCT04312113 | Recruiting | Phase 1 | 20 | Intra-arterial delivery | 1.5×107-3×107 cells | UC | Autologous adipose-derived mesenchymal stem cells | United States |
| NCT04543994 | Recruiting | Phase 1 Phase 2 |
24 | Endoscopic delivery | 1.5×108/3×108cells | UC | Bone marrow mesenchymal stem cell | United States |
| NCT01233960 | Completed | Phase 3 | 73 | Intra-arterial delivery | 2×108 cells | UC | Mesenchymal stem cells | United States |
| NCT03609905 | Recruiting | Phase 1 Phase 2 |
50 | Colonoscope | 5×107 cells | UC | Adipose-cord mesenchymal stromal cells | China |
| NCT03901235 | Recruiting | Phase 1 Phase 2 |
60 | Intratissular injection | n/a | n/a | Mesenchymal stem cells | Belgium |
| NCT02442037 | Recruiting | Phase 1 Phase 2 |
30 | i.v. | 1×106 cell/kg | UC | Umbilical cord derived mesenchymal stem cell | China |
| NCT02580617 | Recruiting | Phase 1 | 9 | n/a | 1.5×107-1×108 cells | CD | Adipose-derived mesenchymal stem cells | Korea |
| NCT01510431 | No longer available | n/a | n/a | n/a | 2×108 cells | CD | Mesenchymal stem cells | United States |
| NCT02403232 | Recruiting | Phase 2 | 10 | n/a | n/a | CD | Adipose tissue-derived stem cells | Italy |
| NCT02403232 | Unknown status | Phase 1 Phase 2 |
24 | i.v. | 0.5×108/1×108 cells | CD | Umbilical cord blood derived-universal stem cells | Korea |
| NCT02926300 | Recruiting | Phase 1 Phase 2 |
24 | n/a | n/a | CD | Stem cells | Korea |
| NCT03220243 | Completed | Phase 1 | 5 | Local injection | 2×107 cells | CD | Mesenchymal stromal cell | United States |
| NCT01915927 | Completed | Phase 1 | 20 | Local injection | 2×107 cells | CD | Mesenchymal stromal cell | United States |
| NCT03449069 | Recruiting | Phase 1 | 5 | Local injection | 2×107 cells | CD | Mesenchymal stromal cell | United States |
n/a, not applicable.