Table 3.
Main clinical trials using low‐dose IL‐2 or cell‐based therapies in recent onset T1D patients
| New onset trials | Drug | Type of study |
|---|---|---|
| Low‐dose IL‐2 | ||
| NCT01827735 (DILT1D) | Proleukin (IL‐2) | Phase 1/2, onset < 24 months |
| NCT02265809 (DILfrequency) | Aldesleukin (IL‐2) | Phase 1/2, onset < 60 months |
| NCT01353833 (DF‐IL2) | Aldesleukin (IL‐2) | Phase 1/2, onset < 24 months |
| NCT01862120 (DFIL2‐Child) | IL‐2 | Phase 2, recent onset |
| NCT02411253 (DIABIL‐2) | rhIL‐2 | Phase 2, recent onset |
| Cell‐based therapies | ||
| ISRCTN06128462 (Gdansk) | Polyclonal Tregs | Phase 1, onset < 2 months |
| NCT01210664 (UCSF) | Polyclonal Tregs | Phase 1, onset 3‐24 months |
| NCT00445913 (Pittsburgh) | Autologous DCs | Phase 1, long‐term T1D (5y+) |
| NCT02354911 (Pittsburgh) | Autologous DCs | Phase 2, new onset < 100d |
| NCT01068951 (Uppsala) | MSCs | Phase 1, new onset |
| NCT00690066 (Mesoblast) | Prochymal (MSCs) | Phase 2, onset 2‐20 wks |
| NCT02057211 (Uppsala) | MSCs | Phase 2, new onset < 3 weeks |
| NCT01322789 (Sao Paulo) | MSCs | Phase 1/2, new onset < 6 weeks |
| NCT00305344 (Florida) | Umbilical cord blood (UCB) | Phase 1/2, post‐onset |
| NCT00989547 (Munich) | Umbilical cord blood (UCB) | Phase 1, post‐onset |
| NCT01350219 (Tianhe) | UCB‐derived stem cells | Phase 2, post‐onset |
| NCT01996228 (Tianhe) | UCB‐derived stem cells | Phase 1/2, post‐onset |
| NCT00315133 (Sao Paulo) | Autologous HSCs | Phase 1/2, onset < 12 weeks |
| NCT01285934 (Northwestern) | Autologous HSCs | Phase 1/2, onset < 5 months |
Note: Clinical trials are color‐shaded based on whether they are completed, ongoing, or planned. Stem cells used for the generation of new β cells are not covered here. DCs: dendritic cells; HSCs: hematopoietic stem cells; MSCs: mesenchymal stem/stromal cells; Tregs: regulatory T cells.