Servicio de Hematología, Instituto de Biomedicina de Sevilla (IBIS) Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Avenida Manuel Siurot s/n 41013 Sevilla, Spain.
Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.
This trial evaluated the feasibility and efficacy of the infusion of mesenchymal stem cells expanded using human serum for the treatment of refractory acute or chronic graft-versus-host disease. Twenty-eight expansions were started. In 22, a minimum of more than 1 x 10⁶ mesenchymal stem cells/kg were obtained after a median of 26 days; this threshold was not obtained in the remaining cases. Ten patients received cells for the treatment of refractory or relapsed acute graft-versus-host disease and 8 for chronic disease. One patient treated for acute graft-versus-host disease obtained a complete response, 6 had a partial response and 3 did not respond. One of the chronic patients achieved complete remision, 3 a partial response, and 4 did not respond. The current study supports the use of this approach in less heavily treated patients for both acute and chronic graft-versus-host disease. The trial has been registered at ClinicalTrials.gov: identifier NCT00447460.
本试验评估了使用人血清扩增的间充质干细胞输注治疗难治性急性或慢性移植物抗宿主病的可行性和疗效。共进行了 28 次扩增。在 22 次中，中位数为 26 天后获得了至少超过 1×10⁶个间充质干细胞/kg；其余情况下未获得该阈值。10 名患者接受细胞治疗难治性或复发的急性移植物抗宿主病，8 名患者接受慢性疾病治疗。1 名治疗急性移植物抗宿主病的患者获得完全缓解，6 名患者部分缓解，3 名患者无反应。1 名慢性患者获得完全缓解，3 名部分缓解，4 名无反应。目前的研究支持在急性和慢性移植物抗宿主病的治疗中对接受治疗较少的患者使用这种方法。该试验已在 ClinicalTrials.gov 注册：标识符 NCT00447460。
