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脊髓损伤的干细胞临床试验:美国研究综述

Stem Cell Clinical Trials in Spinal Cord Injury: A Brief Review of Studies in the United States.

作者信息

Platt Andrew, David Brian T, Fessler And Richard G

机构信息

Department of Surgery, Section of Neurosurgery, University of Chicago, Chicago, IL 60612, USA.

Department of Neurosurgery, Rush University Medical Center, Chicago, IL 60612, USA.

出版信息

Medicines (Basel). 2020 May 12;7(5):27. doi: 10.3390/medicines7050027.

Abstract

BACKGROUND

Although many therapeutic approaches have been attempted to treat spinal cord injury, cellular transplantation offers the greatest promise in reconstituting the architecture of the damaged cord.

METHODS

A literature review was conducted to search for clinical trials investigating stem cells as treatment for spinal cord injury in the United States.

RESULTS

Overall, eight studies met inclusion criteria. Of the included studies, four were identified as being terminated, suspended, or not yet recruiting. Two studies were identified as currently recruiting, including one phase one trial evaluating stereotactic injections of human spinal cord-derived neural stem cells in patients with chronic spinal cord injuries, and one trial of transplantation of autologous bone marrow derived stem cells via paraspinal injections, intravenous injections, and intranasal placement. One study was identified as an active study, a phase one trial of intrathecal injection of 100 million autologous, ex-vivo expanded, adipose-derived mesenchymal stem cells. One trial that was listed as completed is a phase 1/2a, dose escalation study, investigating stereotactic injection of human embryonic stem cell derived oligodendrocyte progenitor cells.

CONCLUSIONS

Although few significant publications have emerged to this point, current trial results are promising.

摘要

背景

尽管已经尝试了许多治疗方法来治疗脊髓损伤,但细胞移植在重建受损脊髓结构方面最具前景。

方法

进行了一项文献综述,以查找在美国调查将干细胞用作脊髓损伤治疗方法的临床试验。

结果

总体而言,八项研究符合纳入标准。在纳入的研究中,四项被确定为已终止、暂停或尚未招募患者。两项研究被确定为目前正在招募患者,其中一项是一期试验,评估对慢性脊髓损伤患者进行立体定向注射人脊髓源性神经干细胞;另一项试验是通过椎旁注射、静脉注射和鼻内植入移植自体骨髓源性干细胞。一项研究被确定为正在进行的研究,即一期试验,鞘内注射1亿个自体体外扩增的脂肪源性间充质干细胞。一项列为已完成的试验是1/2a期剂量递增研究,调查立体定向注射人胚胎干细胞源性少突胶质细胞祖细胞。

结论

尽管到目前为止几乎没有重要的出版物,但目前的试验结果很有前景。

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