Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trial.
Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trial.
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DOI：
10.1016/j.trci.2015.06.007
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发表时间：
2015-09
期刊：
影响因子：
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通讯作者：
Na DL
中科院分区：
文献类型：
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作者：
Kim HJ;Seo SW;Chang JW;Lee JI;Kim CH;Chin J;Choi SJ;Kwon H;Yun HJ;Lee JM;Kim ST;Choe YS;Lee KH;Na DL
我们在9名轻中度阿尔茨海默病患者中进行了1期临床试验，以评估立体定向脑注射人脐带血来源的间充质干细胞（hUCB-MSCs）的安全性和剂量限制性毒性。低剂量组（n = 3）和高剂量组（n = 6）分别在双侧前穹隆和右侧楔前叶中接受总计3.0 × 106个细胞/60 μL和6.0 × 106个细胞/60 μL。在24个月随访期间，没有患者出现严重不良事件，包括发热。在12周随访期间，最常见的急性不良事件是手术过程中的伤口疼痛（n = 9），其次是头痛（n = 4）、头晕（n = 3）和术后谵妄（n = 3）。没有剂量限制性毒性。通过立体定向注射将hUCB-MSCs注入海马和楔前叶是可行的，安全的，耐受性良好。还需要进一步的试验来检验其有效性。ClinicalTrial.gov标识符NCT 01297218和NCT 01696591。
We conducted a phase 1 clinical trial in nine patients with mild-to-moderate Alzheimer's disease to evaluate the safety and dose-limiting toxicity of stereotactic brain injection of human umbilical cord blood–derived mesenchymal stem cells (hUCB-MSCs). The low- (n = 3) and high-dose (n = 6) groups received a total of 3.0 × 106 cells/60 μL and 6.0 × 106 cells/60 μL, respectively, into the bilateral hippocampi and right precuneus. No patient showed serious adverse events including fever during the 24-month follow-up period. During the 12-week follow-up period, the most common acute adverse event was wound pain from the surgical procedure (n = 9), followed by headache (n = 4), dizziness (n = 3), and postoperative delirium (n = 3). There was no dose-limiting toxicity. Administration of hUCB-MSCs into the hippocampus and precuneus by stereotactic injection was feasible, safe, and well tolerated. Further trials are warranted to test the efficacy. ClinicalTrial.gov identifier NCT01297218 and NCT01696591.