Tianjin Amcellgene Engineering Co., Ltd.

主要目的 评价注射用间充质干细胞（脐带）治疗急性缺血性脑卒中的耐受性和安全性，确定临床用药的范围。 次要目的 初步探索注射用间充质干细胞（脐带）治疗急性缺血性脑卒中患者的有效性，并为后续确证阶段临床试验试验药物剂量的选择提供依据。 探索目的 进一步探索注射用间充质干细胞（脐带）治疗急性缺血性脑卒中患者药代动力学特征及可能的分子机制。

The goal of this clinical trial is to learn if drug mesenchymal stem cells (umbilical cord) injection works to treat acute ischemic stroke in adults. It will also learn about the safety and efficacy of drug mesenchymal stem cells (umbilical cord) injection . The main questions it aims to answer are:
Identify the dose-limiting toxicity (DLT) of drug mesenchymal stem cells (umbilical cord) injection in acute ischemic stroke patients.
Dose the drug mesenchymal stem cells (umbilical cord) injection improves the mRS score, NIHSS score, Fugl-Meyer score and and Barthel index of acute ischemic stroke patients? What is the pharmacokinetic characteristics and immunogenic response of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.
What is the the possible molecular mechanisms of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.
Participants will:
Take drug drug mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks.
After receiving the corresponding dose of mesenchymal stem cells (umbilical cord) injection, the subjects entered a 6-month safety, efficacy observation and further safety evaluation period. Long term efficacy and survival follow-up up to 2 years.

主要目的 评价注射用间充质干细胞（脐带）治疗外伤性脊髓损伤患者的耐受性和安全性，确定临床用药的范围。 次要目的 初步探索注射用间充质干细胞（脐带）治疗外伤性脊髓损伤患者的有效性，并为后续确证阶段临床试验试验药物剂量的选择提供依据。 探索目的 进一步探索注射用间充质干细胞（脐带）治疗外伤性脊髓损伤患者药代动力学特征、免疫原性、可能的分子机制及fMRI和神经电生理检测的变化情况。