Table 1.
Selected clinical trials testing the effectiveness of MSCs on reducing GVHD caused by allogeneic HSC transplantation in cancer patients.
| Disease & Interventions | Phase | Clinical Outcome | NCT/Ref. |
|---|---|---|---|
| Recent Published/Completed Trials | |||
| - Refractory chronic GVHD - Adipose tissue-MSCs (1–3 × 106/kg) & cyclosporine, prednisone |
I/II | 71.4% patients alive, 80% patients achieved complete remission (CR) 100% patients were free of steroids at week 56 No side events related to MSC treatment |
[54] |
| - Steroid-refractory grade III or IV acute GVHD - 72–100 × 106 MSCs |
II/III | At 24 weeks (primary endpoint), 12/25 (48%) patients achieved CR At 52 weeks, 48% patients receiving MSCs were alive No side events related to MSC treatment |
[55] |
| - Refractory acute GVHD - Bone marrow-MSCs (2 × 106 cells/kg), 3 doses for a week |
I | 5/7 patients achieved CR with remarkable decrease in inflammatory cytokines Good correlation between clinical responses with decrease in the level of biomarkers (Elafin, CK18, and Reg 3α) |
[56] |
| - Refractory chronic GVHD - MSCs & mycophenolate mofetil (15 mg/kg × 3 doses/day × 42 days) & tacrolimus (0.06 mg/kg × 2 doses/day × 180 days) |
II | At 100 days (primary endpoint), < 35% nonrelapse mortality (NRM) 19/20 patients achieved sustained engraftment of HSCs At 1 year, 10% NRM, 30% relapse, 80% overall survival, 60% non-relapse survival |
NCT00504803/ [57] |
| - Sclerodermatous GVHD - Bone marrow-MSCs (10–20 × 106 cells, infusion into anterosuperior iliac spine) |
I | Reduce symptoms in all 4 patients. Dramatic increase in Th1/Th2 cell ratio No side events related to MSC treatment |
[58] |
| Ongoing Trial | |||
| Mesenchymoangioblast derived MSCs | I | Ongoing | NCT02923375 |