|
| Ref | Phase | No. of pts | GVHD type | GVHD location | MSC source
(no of doses) | MSC dose
(×106 cells/kg,
median (range)) | No of doses/pt
(no of pt) | Time from Tplt
(days, median (range)) | Time from GVHD sx/dx
(days, median (range)) | Clinical response | TRM | Relapsed dz | Morbidity | Survival (after transplant) |
|
| [25] | Pilot/I | 7 | Acute (6):
III (5),
IV (1).
Chronic (1):
extensive. | S (1).
G (1).
S/G (3). | BM: MF (2),
haplo (3),
MM (3) | 1.2
(0.6–2) | 1 (6).
2 (1). | 136.5
(32–283) | 23
(7–90) | aGVHD (6):
CR (5), NR (1).
cGVHD (1): NR. | NA | 1 from aGVHD group | Infection (2) | aGVHD: Alive (5), 2–36 mo;
dead (2): 9 mo. cGVHD: dead (1), 12 mo. |
|
| [27]* | II | 30 | 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 (30):
CR (13), PR (5),
SD (1), PD (11). | 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 extensive cGVHD (2). | Est. 2-yr survival: 26%
(95% CI: 10–42%) |
|
| [28] | Pilot/I | 3 | Acute (3):
III (3). | G (1),
S/G (1),
S/H/G (1) | BM: haplo (3) | 0.51
(0.32–2) | 1 (3) | 120
(96–158) | 92
(76–136) | aGVHD (3):
NR (3). | NA | None | Infection (1). | aGVHD: dead (3),
177, 178, 199 days. |
|
| [29] | Pilot/I | 4 | Chronic (4):
extensive. | Sclerodermatous (4). | BM: MM (23). | 1.8
(1.0–2.0)
× 107 total cells/dose | 4 (2),
7 (1),
8 (1). | 13.8
(4.5–37.3) months | NA | cGVHD (4):
PR (4). | NA | None | NA | cGVHD: alive (4),
4.6–23 mo. |
|
|
[30] | I/II | 18 | Acute (10):
II (3),
III (2),
IV (5).
Chronic (8):
limited (1),
extensive (7) | G (8),
S/G (5),
S/M (1),
G/M (1).
S/H/G (3), | BM: MF (4),
haplo (14). | 1.0
(0.2–2.9) | 1 (6),
2 (7),
3 (1),
4 (4). | NA | NA | aGVHD (10):
CR(1) PR(6) NR(3)
cGVHD (8):
CR(1) PR(3) NR(4) | NA | 2 from aGVHD group. | aGVHD group: infection (5),
VOD (1). | aGVHD: alive (1), dead (9).
cGVHD: alive (5), dead (3). |
|
| [31] | Pilot/I | 13 | Acute (13):
III (2), IV (11) | G (2),
S/G (1),
S/H (2),
H/G (5),
S/H/G (3). | BM: MM (all). | 0.9
(0.6–1.1) | 1(1). 2(8)
3(2). 4(1)
5(1). | 41
(20–91) | 16
(4–31) | aGVHD (13):
CR (1), PR (1),
MR (5), NR (6). | NA | NA | Infection (3). | aGVHD: alive (4), 185–692 days;
dead (9). |
|
| [32] | Pilot/I | 6 | Acute (6):
III (2),
IV (4). | H (1),
S/H (2),
S/G (2),
S/H/G (1). | Adipose: haplo (2),
MM (4). | 1.0 | 1 | 71
(65–243) | 38.5
(7–58) | aGVHD (6):
CR (5), NR (1). | NA | 1 from aGVHD group | No major infections reported. | aGVHD: alive (4), 18–90 mo;
dead (2), 0.5, 13 mo. |
|
| [33] | II | 31 | De novo acute (31):
II (21),
III (7),
IV (3). | S (13),
G (11),
multiorgan (7). | BM: MM
(all Prochymal) | 15 pts received dose of 2.0.
16 pts received dose of 8.0. | 2 | NA | within 48 hrs of diagnosis | aGVHD (31):
CR (24), PR (5). | NA | aGVHD (3) | Infection (18) | aGVHD at 90 days:
alive (22), dead (9). |
|
