Table 2 Clinical findings of the MSCs therapy in IBD patients
MSC type | IBD type | Administration schedule | Number of patients | Follow-up duration | Clinical phase | Outcome | References | |
|---|---|---|---|---|---|---|---|---|
BM-MSCs | Autologous | Luminal CD | Two doses of 1–2 × 106 cells/kg, IV injection, 7 days apart | 9 | 6 weeks | Phase I | The decrease in CDAI score in 3 patients after 6 weeks | [26] |
CD | A single dose of 2 × 107, 5 × 107, or 10 × 107 cells/kg, IV injection | 12 | 2 weeks | Phase I | Safe and feasible at the doses of up to 10 million cells/kg | [27] | ||
Allogeneic | Perianal fistulizing CD | A single dose of 1 × 107, 3 × 107, or 9 × 107, local injection | 24 | 24 weeks | Phase II | No severe adverse events 3 × 107 MSCs induced healing of perianal fistulas | [24] | |
UC/CD | A single dose of (1.5–2) × 108, IV injection | 21 | 6, 12, and 24 weeks | Phase II | The decrease in the clinical and morphological indices of inflammatory activity in 34 (72%) patients | [28] | ||
Luminal CD | A single dose of 2 × 106 cells/kg weekly for 4 weeks, IV injection | 16 | 6 weeks | Phase II | The decrease in CDAI score in 15 patients after 6 weeks | [25] | ||
AD-MSCs | Autologous | Perianal fistulizing CD | 2 × 107 cells/kg, local injection | 12 | 24 weeks | Phase I | Complete clinical healing in 9 patients after 12 weeks Complete clinical healing in 10 patients after 24 weeks | [33] |
Perianal fistulizing CD | 1 × 107, 2 × 107, or 4 × 107 cells/ml in three groups | 9 | 8 weeks | Phase I | 2 patients treated with 2 × 107 cells/ml showed complete healing and 3 patients treated with 4 × 107 cells/ml showed complete healing at week 8 | [34] | ||
Perianal fistulizing CD | 3 × 107 cells per centimeter length of the fistula | 43 | 8 weeks | Phase II | Complete fistula healing in 27/33 (82%) patients after 8 weeks Complete closure of fistula in 23/26 (88%) patients after 1 year | [32] | ||
Allogeneic | Perianal fistulizing CD | A single dose of 1.2 × 108, Intralesional injection | 212 | 24 weeks | Phase III | Combined remission in 50% of patients | [30] | |
Perianal fistulizing CD | A single dose intralesionally If 2 × 107 failed, 4 × 107 subsequently | 24 | 24 weeks | Phase II | The decrease in the number of draining fistulas in 69.2% of patients Complete fistula closure treated in 56.3% of patients Complete closure of all existing fistula tracts in 30% of patients | [35] | ||
hUC-MSCs | Allogeneic | UC/CD | 1 × 106 cells/kg, IV injection | 7 | 6 months | Phase I | The decrease in clinical activity index scores in all patients The decrease in fistula size and drainage in one patient The decrease in rough mucosa, polypoid lesions, and ulcers in three patients The decrease in the extent of the inflamed area and the dense lymphocytic infiltration in the mucosa propria A relapse in two patients at 6 and 7 months after treatment At the 3-month visit, five patients achieved remission and maintenance of remission lasted for more than 24 months in two patients | [36] |