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Clinical Trials associated with Adipose-derived mesenchymal stem cells(Saier) / Not yet recruitingPhase 1 评价脂肪间充质干细胞注射液在2 型糖尿病患者中的安全性、耐受性及初步有效性
的I期临床试验
[Translation] A Phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of adipose-derived mesenchymal stem cell injection in patients with type 2 diabetes.
主要目的:
评价脂肪间充质干细胞注射液治疗2型糖尿病患者的安全性和耐受性,为后续临床试验推荐合适的治疗剂量和给药频次和间隔。
次要目的:
评价脂肪间充质干细胞注射液在2型糖尿病患者中的初步有效性。
探索性目的:
(1) 探索脂肪间充质干细胞注射液在2型糖尿病患者中的免疫原性;
(2) 探索脂肪间充质干细胞注射液在2型糖尿病患者中药代动力学特征;
(3) 探索脂肪间充质干细胞注射液在2型糖尿病患者中药效学特征;
(4) 探索脂肪间充质干细胞注射液对2型糖尿病患者的体重、甘油三酯的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of adipose-derived mesenchymal stem cell injection in patients with type 2 diabetes mellitus, and to recommend appropriate treatment doses, dosing frequencies, and intervals for subsequent clinical trials.
Secondary Objective: To evaluate the preliminary efficacy of adipose-derived mesenchymal stem cell injection in patients with type 2 diabetes mellitus.
Exploratory Objectives:
(1) To explore the immunogenicity of adipose-derived mesenchymal stem cell injection in patients with type 2 diabetes mellitus;
(2) To explore the pharmacokinetic characteristics of adipose-derived mesenchymal stem cell injection in patients with type 2 diabetes mellitus;
(3) To explore the pharmacodynamic characteristics of adipose-derived mesenchymal stem cell injection in patients with type 2 diabetes mellitus;
(4) To explore the effects of adipose-derived mesenchymal stem cell injection on body weight and triglycerides in patients with type 2 diabetes mellitus.
100 Clinical Results associated with Adipose-derived mesenchymal stem cells(Saier)
100 Translational Medicine associated with Adipose-derived mesenchymal stem cells(Saier)
100 Patents (Medical) associated with Adipose-derived mesenchymal stem cells(Saier)
100 Deals associated with Adipose-derived mesenchymal stem cells(Saier)