|
| Ref | Phase | No. of pts | GVHD type | GVHD location | Type of MSC (no of doses) | MSC dose (×106 cells/kg, median (range)) | No. of doses/pt (no of pts) | Time from Tplt (days, median (range)) | Time from GVHD sx/dx (days, median (range)) | Clinical response | TRM | Relapsed/
progressive
primary disease | Morbidity | Survival (after transplant) |
|
| [25] | Pilot | 2 | acute (2): III (1), IV (1) | G (1). H/G (1). | BM: haplo (3), MM (1) | 1.2 (0.7–2) | 2 (2) | 88.5 (73–170) | 52, 63 | aGVHD (2): CR (1), NR (1) | NA | NA | aGVHD: EBV PTLD (1) | aGVHD: dead (2), 3 mo, 12 mo. |
|
| [26] | Pilot/I | 5 | acute (2): II (1), III (1). Chronic (3): extensive (3). | S/G (1), S/H/G (3), S/H/L/G (1). | BM: MF (1), MUD (2), haplo (2). | 2.0 (0.4–3.0) | 1 (3), 2 (2). | 250 (80–768) | NA | aGVHD (2): CR (1), NR (1). cGVHD (3): MR (1), NR (2). | NA | 1 from aGVHD group. | cGVHD: EBV PTLD (1) | aGVHD: alive (1), 4 yrs; dead (1), NA.
cGVHD: alive (1), 4 yrs; dead (2), 2.25–3 yrs, |
|
| [27]* | II | 25 | acute (55): II (5), III (25), IV (25).* | S (3), H (1), G (6). S/G (15, H/G (7), S/H (4). S/H/G (19).* | BM: MF (5), haplo (18), MM (69).* | 1.4 (0.4–9)* | 1 (27), 2 (22), 3 (4), 4 (1),
5 (1).* | 103 (27–533)* | NA | aGVHD (25): CR (17), PR (4), SD (2), PD (2). | 1-yr from MSC: CR 37% (95% CI: 19–55%), non-CR 72% (95% CI: 55–89%), P = 0.002.* | 3 from aGVHD group* | EBV PTLD (1).*development of cGVHD: limited (2), extensive (4). De novo AML (1). | Est. 2-yr survival: 45% (95% CI: 23–67%) |
|
| [34] | Pilot/I | 12 | acute (12):
III (5), IV (7). | G (5), S/G (3), H/G (2), S/H/G (1). | BM: MM (Prochymal) | Two pts: 8.0.
Ten pts: 2.0. | 2 (1), 3 (1),
7 (1), 8 (3),
9 (1), 12 (4),
21 (1). | 98 (45–237) | 46 (18–157) | aGVHD (12): CR (7), PR (2). | NA | NA | Infection (7), EBV PTLD (1). | Est. 2-yr survival: 40% (95% CI: 20–82%). |
|
