Journal
BONE MARROW TRANSPLANTATION
Volume 56, Issue 10, Pages 2355-2366Publisher
SPRINGERNATURE
DOI: 10.1038/s41409-021-01304-y
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Funding
- Japan Society for the Promotion of Science (JSPS) [18K08321]
- Japan Agency for Medical Research and Development (AMED) [JP20ek0510032]
- Grants-in-Aid for Scientific Research [18K08321] Funding Source: KAKEN
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The study presents initial experience with Temcell in a real-world setting for the treatment of acute GVHD, showing promising initial efficacy and suggesting it as a treatment option for steroid-refractory acute GVHD until a new treatment with survival benefit is developed.
Temcell is a cryopreserved, human bone marrow-derived mesenchymal stem cell (MSC) product approved for the treatment of patients of all ages with acute graft-versus-host disease (GVHD). Initial experience with Temcell in a real-world setting from a cellular therapy registry in Japan is presented. A total of 381 consecutive patients were enrolled since its approval in 2016. The median cell number infused was 2.00 x 10(6)/kg. The most common number of infusions was 8 in 100 patients. Of the 306 evaluable patients, the overall response rate (ORR) on day 28 after the start of MSC therapy was 56%. Of the 151 evaluable patients who received it as second-line therapy following first-line steroid therapy for classic acute GVHD, the ORR was 61%. Liver involvement of GVHD and >= 14 days from first-line steroid therapy to second-line MSC therapy was associated with a lower ORR. Day 28 ORR, patient age, GVHD grade, GVHD organ involvement, and a number of GVHD therapies before MSC therapy were associated with nonrelapse mortality. Overall survival at 6 months in 381 patients was 40%. This study suggests that Temcell is one of the treatment options for steroid-refractory acute GVHD until a new treatment with survival benefit is developed.
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