TY - JOUR
T1 - Unrelated allogeneic bone marrow-derived mesenchymal stem cells for steroid-refractory acute graft-versus-host disease
T2 - A phase I/II study
AU - Muroi, Kazuo
AU - Miyamura, Koichi
AU - Ohashi, Kazuteru
AU - Murata, Makoto
AU - Eto, Tetsuya
AU - Kobayashi, Naoki
AU - Taniguchi, Shuichi
AU - Imamura, Masahiro
AU - Ando, Kiyoshi
AU - Kato, Shunichi
AU - Mori, Takehiko
AU - Teshima, Takanori
AU - Mori, Masaki
AU - Ozawa, Keiya
PY - 2013/8
Y1 - 2013/8
N2 - We conducted a multicenter phase I/II study using mesenchymal stem cells (MSCs) manufactured from the bone marrow of healthy unrelated volunteers to treat steroid-refractory acute graft-versus-host disease (aGVHD). Fourteen patients with hematological malignancies who suffered from grade II (9 patients) or III aGVHD (5) were treated. Affected organs were gut (10 patients), skin (9 patients), and liver (3 patients). Seven patients had two involved organs. The median age was 52. No other second-line agents were given. MSCs were given at a dose of 2 × 106 cells/kg for each infusion twice a week for 4 weeks. If needed, patients were continuously given MSCs weekly for an additional 4 weeks. By week 4, 13 of 14 patients (92.9 %) had responded to MSC therapy with a complete response (CR; n = 8) or partial response (PR; n = 5). At 24 weeks, 11 patients (10 with CR and 1 with PR) were alive. At 96 weeks, 8 patients were alive in CR. A total of 6 patients died, attributable to the following: underlying disease relapse (2 patients), breast cancer relapse (1), veno-occlusive disease (1), ischemic cholangiopathy (1), and pneumonia (1). No clear adverse effects associated with MSC infusion were observed. Third party-derived bone marrow MSCs may be safe and effective for patients with steroid-refractory aGVHD.
AB - We conducted a multicenter phase I/II study using mesenchymal stem cells (MSCs) manufactured from the bone marrow of healthy unrelated volunteers to treat steroid-refractory acute graft-versus-host disease (aGVHD). Fourteen patients with hematological malignancies who suffered from grade II (9 patients) or III aGVHD (5) were treated. Affected organs were gut (10 patients), skin (9 patients), and liver (3 patients). Seven patients had two involved organs. The median age was 52. No other second-line agents were given. MSCs were given at a dose of 2 × 106 cells/kg for each infusion twice a week for 4 weeks. If needed, patients were continuously given MSCs weekly for an additional 4 weeks. By week 4, 13 of 14 patients (92.9 %) had responded to MSC therapy with a complete response (CR; n = 8) or partial response (PR; n = 5). At 24 weeks, 11 patients (10 with CR and 1 with PR) were alive. At 96 weeks, 8 patients were alive in CR. A total of 6 patients died, attributable to the following: underlying disease relapse (2 patients), breast cancer relapse (1), veno-occlusive disease (1), ischemic cholangiopathy (1), and pneumonia (1). No clear adverse effects associated with MSC infusion were observed. Third party-derived bone marrow MSCs may be safe and effective for patients with steroid-refractory aGVHD.
KW - GVHD
KW - Mesenchymal stem cells
KW - Steroid
UR - http://www.scopus.com/inward/record.url?scp=84882246890&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84882246890&partnerID=8YFLogxK
U2 - 10.1007/s12185-013-1399-4
DO - 10.1007/s12185-013-1399-4
M3 - Article
C2 - 23860964
AN - SCOPUS:84882246890
SN - 0925-5710
VL - 98
SP - 206
EP - 213
JO - International journal of hematology
JF - International journal of hematology
IS - 2
ER -
