Bone marrow-derived mesenchymal stem cells (JR-031) for steroid-refractory grade III or IV acute graft-versus-host disease: a phase II/III study.

Abstract	Following a phase I/II study using mesenchymal stem cells (MSCs; JR-031) for steroid-refractory grade II or III acute graft-versus-host disease (aGVHD), a phase II/III study using the cells focused on steroid-refractory grade III or IV aGVHD was conducted. The number of infused MSCs and the number of MSC infusions were the same as the phase I/II study. No additional immunosuppressant was given for steroid-refractory aGVHD during the course of MSC infusions. Twenty-five patients (grade III, 22 patients and grade IV, 3 patients) were enrolled in this study. At 4 weeks after the first MSC infusions, six (24 %) and nine patients (36 %) achieved a complete response (CR) and partial response (PR), respectively. Durable CR by 24 weeks, which was the primary end-point, was obtained in 12 of 25 patients (48 %). At 52 weeks, 12 patients (48 %) treated with MSCs only (six patients) and MSCs plus additional treatments (six patients) were alive in CR. The survival was significantly better in patients showing overall response (OR; CR+PR) than in those showing no OR at 4 weeks. Adverse effects commonly associated with MSC infusions were not observed. Taken together, our two clinical trials suggest JR-031 to be effective for steroid-refractory aGVHD.
Authors	Kazuo Muroi, Koichi Miyamura, Masaya Okada, Takuya Yamashita, Makoto Murata, Takayuki Ishikawa, Naokuni Uike, Michihiro Hidaka, Ryoji Kobayashi, Masahiro Imamura, Junji Tanaka, Kazuteru Ohashi, Shuichi Taniguchi, Takashi Ikeda, Tetsuya Eto, Masaki Mori, Mariko Yamaoka, Keiya Ozawa
Journal	International journal of hematology (Int J Hematol) Vol. 103 Issue 2 Pg. 243-50 (Feb 2016) ISSN: 1865-3774 [Electronic] Japan
PMID	26608364 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article)
Chemical References	Prednisolone Methylprednisolone
Topics	Acute Disease Adolescent Adult Aged Child Child, Preschool Female Graft vs Host Disease (therapy) Humans Male Mesenchymal Stem Cell Transplantation Methylprednisolone (therapeutic use) Middle Aged Prednisolone (therapeutic use) Severity of Illness Index Treatment Failure Treatment Outcome Young Adult

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.

Realize the full power of the drug-disease research graph!