Target- |
MechanismStem cell replacements |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项在感染所致急性呼吸窘迫综合征(ARDS)患者中评估注射用间充质干细胞(脐带)的安全性、耐受性和初步疗效的单臂、开放性探索性临床研究
[Translation] A single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, and preliminary efficacy of injectable mesenchymal stem cells (umbilical cord) in patients with infection-induced acute respiratory distress syndrome (ARDS)
主要目的 (1)评价注射用间充质干细胞(脐带)治疗急性呼吸窘迫综合征(ARDS)患者的安全性和耐受性,初步探讨其临床疗效及可能机制。 (2)DLTs 的发生例数和严重程度
次要目的 (1)初步观察注射用间充质干细胞(脐带)治疗急性呼吸窘迫综合征(ARDS)是否可降低患者 28 天死亡风险。 (2)评价有创机械通气患者从输注 MSCs 后 28 天内,无机械通气总时间。 (3)氧合指数(OI)变化(时间范围:从第 0 天到第 7 天或离开 ICU,以先发生的为准,每天测量一次)。 (4)肺损伤评分(LIS)(时间范围:根据肺损伤评分相关项,胸部 CT或胸部 X 线、PEEP、氧合指数和静态肺顺应性(如可测得)等实测时间确定)
[Translation] Main purposes (1) To evaluate the safety and tolerability of injectable mesenchymal stem cells (umbilical cord) in the treatment of patients with acute respiratory distress syndrome (ARDS), and to preliminarily explore its clinical efficacy and possible mechanisms. (2) Number of occurrences and severity of DLTs
Secondary purpose (1) To initially observe whether injecting mesenchymal stem cells (umbilical cord) to treat acute respiratory distress syndrome (ARDS) can reduce the risk of 28-day death in patients. (2) To evaluate the total time without mechanical ventilation in patients with invasive mechanical ventilation within 28 days from the infusion of MSCs. (3) Oxygenation index (OI) changes (time range: from day 0 to day 7 or discharge from ICU, whichever occurs first, measured once a day). (4) Lung injury score (LIS) (time range: determined based on lung injury score related items, chest CT or chest X-ray, PEEP, oxygenation index and static lung compliance (if measurable) and other actual measurement times)
注射用间充质干细胞(脐带)治疗难治性急性移植物抗宿主病(aGvHD)临床试验(多次给药)
[Translation] Clinical trial of mesenchymal stem cells (umbilical cord) for injection in the treatment of refractory acute graft-versus-host disease (aGvHD) (multiple doses)
主要目的 评价注射用间充质干细胞(脐带)多次给药治疗难治性aGvHD患者的耐受性和安全性,确定临床用药安全范围
次要目的 初步观察注射用间充质干细胞(脐带)多次给药治疗难治性aGvHD患者的有效性,为后续临床试验方案设计提供依据
探索目的 初步探索注射用间充质干细胞(脐带)多次给药治疗难治性aGvHD患者中的药代动力学特征、免疫原性和可能的机制
[Translation] Main objective To evaluate the tolerability and safety of multiple administration of mesenchymal stem cells (umbilical cord) for injection in patients with refractory aGvHD, and to determine the safety range of clinical medication
Secondary objective To preliminarily observe the efficacy of multiple administration of mesenchymal stem cells (umbilical cord) for injection in the treatment of patients with refractory aGvHD, and to provide a basis for the design of subsequent clinical trials
Exploratory purpose To initially explore the pharmacokinetic characteristics, immunogenicity and possible mechanism of multiple administration of mesenchymal stem cells (umbilical cord) for injection in patients with refractory aGvHD
注射用间充质干细胞(脐带)治疗慢加急性(亚急性)肝衰竭的多中心、单臂、开放的Ⅰ/Ⅱ期临床试验
[Translation] A multicenter, single-arm, open-label phase I/II clinical trial of mesenchymal stem cells (umbilical cord) for injection in the treatment of acute-on-chronic (subacute) liver failure
主要目的
评价注射用间充质干细胞(脐带)治疗慢加急性(亚急性)肝衰竭(Acute on chronic liver failure, ACLF)患者的耐受性和安全性,确定临床用药安全范围。
次要目的
初步观察注射用间充质干细胞(脐带)治疗慢加急性(亚急性)肝衰竭的有效性,为后续临床试验方案设计提供依据。
探索目的
初步探索注射用间充质干细胞(脐带)在治疗慢加急性(亚急性)肝衰竭患者中的药代动力学特征、免疫原性及可能的分子机制。
[Translation] main purpose
To evaluate the tolerance and safety of mesenchymal stem cells (umbilical cord) for injection in the treatment of patients with acute on chronic (subacute) liver failure (ACLF), and to determine the safety range of clinical medication.
secondary purpose
To preliminarily observe the effectiveness of mesenchymal stem cells (umbilical cord) for injection in the treatment of acute-on-chronic (subacute) liver failure, and provide a basis for the design of subsequent clinical trials.
explore purpose
To initially explore the pharmacokinetic characteristics, immunogenicity and possible molecular mechanisms of mesenchymal stem cells (umbilical cord) for injection in the treatment of patients with acute-on-chronic (subacute) liver failure.
100 Clinical Results associated with Tianjin Amcellgene Engineering Co., Ltd.
0 Patents (Medical) associated with Tianjin Amcellgene Engineering Co., Ltd.
20 Jul 2013·Shipin Yanjiu Yu Kaifa
Effects of enzyme preparation on quality of bread
Author: Feng, Li ; Xie, Yun ; Wang, Shan-shan ; Hou, Hui-juan
We studied the effects of xylanase, lipase and protease on the quality and staling of bread. The optimum processing conditions were obtained by orthogonal test. The results showed that the optimal adding level was 0.001% xylanase, 0.00013% lipase and none protease. Lipase was the major factors effects of sensatory. There enzyme preparation effected bread hardness and crumbliness together.
100 Deals associated with Tianjin Amcellgene Engineering Co., Ltd.
100 Translational Medicine associated with Tianjin Amcellgene Engineering Co., Ltd.