Phase II Trial of Parathyroid Hormone after Double Umbilical Cord Blood Transplantation

Phase II Trial of Parathyroid Hormone after Double Umbilical Cord Blood Transplantation
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DOI:
10.1016/j.bbmt.2012.06.016
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发表时间:
2012-12-01
影响因子:
4.3
通讯作者:
Antin, Joseph H.
Antin, Joseph H.
中科院分区:
医学2区
文献类型:
--
作者:
Ballen, Karen;Mendizabal, Adam M.;Antin, Joseph H.

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移植1或2种脐带血制品是一种有用的替代干细胞来源。然而,每次输注中有限数量的干细胞导致缓慢的植入。在小鼠模型中,给予甲状旁腺激素(PTH)是增强有限数量造血干细胞支持造血的能力的有效方法。在这项研究中,患者接受清髓性或降低强度的双脐带血移植,随后以100 μ g/天的PTH治疗28天。13例患者(中位年龄42岁)入组。所有患者均植入;中性粒细胞和血小板植入> 20 x 10(9)个细胞/L的中位时间分别为30天和61天。第100天时,II-IV级急性GVHD的发生率为38.5%。4例死亡发生在第100天之前,促使研究提前结束。接受清髓性方案的患者无复发。移植后6个月的总生存率为62%,2年的无病生存率为39%。在研究的剂量和时间表中,没有证据表明PTH影响血细胞计数恢复。Biol Blood Marrow Transplant 18:1851-1858(2012)(c)2012年美国血液和骨髓移植学会
Transplantation of 1 or 2 umbilical cord blood products is a useful alternative stem cell source. However, the limited number of stem cells in each infusion results in slow engraftment. In mouse models, administration of parathyroid hormone (PTH) is an effective way to enhance the ability of limited numbers of hematopoietic stem cells to support hematopoiesis. In this study, patients received either a myeloablative or a reduced-intensity double umbilical cord blood transplantation, followed by PTH at 100 mu g/day for 28 days. Thirteen patients (median age, 42 years) were enrolled. All patients engrafted; the median time to neutrophil and platelet engraftment of > 20 x 10(9) cells/L was 30 days and 61 days, respectively. The incidence of grade II-IV acute GVHD was 38.5% at day 100. Four deaths occurred before day 100, prompting early study closure. No patient who received a myeloablative regimen relapsed. Overall survival at 6 months after transplantation was 62%, and disease-free survival at 2 years was 39%. At the dose and schedule studied, there was no evidence that PTH influenced blood count recovery. Biol Blood Marrow Transplant 18: 1851-1858 (2012) (c) 2012 American Society for Blood and Marrow Transplantation