Main clinical studies with graft manipulation and Treg and Tcon add backs for prevention of GVHD
| Study . | HCT type . | Patients . | Treg isolation . | Treg number/kg . | Immune suppression . | GVHD outcome . | Relapse incidence . |
|---|---|---|---|---|---|---|---|
| Brunstein et al. (2011)66 | Cord blood | 23 | Magnetic separation In vitro expansion | 1 × 105 to 3 × 106 | MMF, CsA | aGVHD II-IV (43%) aGVHD III-IV (17%) cGVHD (14%) | 34.8% |
| Di Ianni et al. (2011)65 | Haploidentical | 28 | Magnetic separation | 2 × 106 to 4 × 106 | None | aGVHD (2/26) No cGVHD | 3.6% |
| Martelli et al. (2014)67 | Haploidentical | 43 | Magnetic separation | 2 × 106 | None | aGVHD (6/41) cGVHD (1/41) | 4.9% |
| Brunstein et al. (2016)75 | Cord blood | 11 | Magnetic separation In vitro expansion | 3 × 106 to 100 × 106 | Sirolimus, MMF | aGVHD II-IV (9%), cGVHD (0%) | 33% |
| Meyer et al. (2019)69 | HLA-matched | 7 | Magnetic separation and cell sorting | 1 × 106 to 3 × 106 | Tacrolimus or sirolimus | aGVHD (0%), cGVHD (0%) | 42.9% |
| Pierini et al. (2021)68 | Haploidentical | 50 | Magnetic separation | 2 × 106 | None | aGVHD (33%), cGVHD (2%) | 4% |
| Bader et al. (2024)70 | HLA-matched | 12 | Magnetic separation | 2.5 × 106 | None | aGVHD (58%), cGVHD (28%) | 8.3% |
| 12 | 2.5 × 106 | Tacrolimus | aGVHD (8%), cGVHD (0%) | 33% |
| Study . | HCT type . | Patients . | Treg isolation . | Treg number/kg . | Immune suppression . | GVHD outcome . | Relapse incidence . |
|---|---|---|---|---|---|---|---|
| Brunstein et al. (2011)66 | Cord blood | 23 | Magnetic separation In vitro expansion | 1 × 105 to 3 × 106 | MMF, CsA | aGVHD II-IV (43%) aGVHD III-IV (17%) cGVHD (14%) | 34.8% |
| Di Ianni et al. (2011)65 | Haploidentical | 28 | Magnetic separation | 2 × 106 to 4 × 106 | None | aGVHD (2/26) No cGVHD | 3.6% |
| Martelli et al. (2014)67 | Haploidentical | 43 | Magnetic separation | 2 × 106 | None | aGVHD (6/41) cGVHD (1/41) | 4.9% |
| Brunstein et al. (2016)75 | Cord blood | 11 | Magnetic separation In vitro expansion | 3 × 106 to 100 × 106 | Sirolimus, MMF | aGVHD II-IV (9%), cGVHD (0%) | 33% |
| Meyer et al. (2019)69 | HLA-matched | 7 | Magnetic separation and cell sorting | 1 × 106 to 3 × 106 | Tacrolimus or sirolimus | aGVHD (0%), cGVHD (0%) | 42.9% |
| Pierini et al. (2021)68 | Haploidentical | 50 | Magnetic separation | 2 × 106 | None | aGVHD (33%), cGVHD (2%) | 4% |
| Bader et al. (2024)70 | HLA-matched | 12 | Magnetic separation | 2.5 × 106 | None | aGVHD (58%), cGVHD (28%) | 8.3% |
| 12 | 2.5 × 106 | Tacrolimus | aGVHD (8%), cGVHD (0%) | 33% |
Some of the most relevant clinical studies that employed Treg and Tcon add backs to improve GVHD prevention and allow for strong antileukemic activity.
aGvHD, acute GvHD; cGvHD, chronic GvHD; CsA, cyclosporine A; MMF, mycophenolate mofetil.