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Clinical Trials associated with Human Umbilical Cord Mesenchymal Stem Cell(Qilu Cell Therapy)一项评价YFQLXB-UC01注射液静脉输注治疗失代偿期肝硬化的安全性、耐受性及有效性临床试验
[Translation] A clinical trial to evaluate the safety, tolerability and efficacy of intravenous infusion of YFQLXB-UC01 injection in the treatment of decompensated liver cirrhosis
Ⅰ期(单次+多次给药、随机开放、剂量递增)
主要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的安全性和耐受性,确定临床用药的安全剂量。
次要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的初步有效性,为后续临床试验方案设计提供依据。
探索性目的:
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药代动力学特征和免疫原性。
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药效动力学(PD)特征。
Ⅱ期(多次给药、随机双盲、安慰剂对照)
主要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的初步有效性。
次要目的:
评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的安全性和耐受性。
探索性目的:
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药代动力学特征和免疫原性。
探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药效动力学(PD)特征
[Translation] Phase I (single + multiple administration, randomized open, dose escalation)
Main purpose:
To evaluate the safety and tolerability of YFQLXB-UC01 injection in patients with decompensated cirrhosis and determine the safe dose for clinical use.
Secondary purpose:
To evaluate the preliminary efficacy of YFQLXB-UC01 injection in patients with decompensated cirrhosis and provide a basis for the design of subsequent clinical trial programs.
Exploratory purpose:
To explore the pharmacokinetic characteristics and immunogenicity of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
To explore the pharmacodynamic (PD) characteristics of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
Phase II (multiple administration, randomized double-blind, placebo-controlled)
Main purpose:
To evaluate the preliminary efficacy of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
Secondary purpose:
To evaluate the safety and tolerability of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
Exploratory purpose:
To explore the pharmacokinetic characteristics and immunogenicity of YFQLXB-UC01 injection in patients with decompensated cirrhosis.
To explore the pharmacodynamic (PD) characteristics of YFQLXB-UC01 injection in patients with decompensated cirrhosis
/ Not yet recruitingPhase 1/2 一项评价YFQLXB-UC01注射液治疗慢加急性肝衰竭患者的安全性、耐受性和初步有效性的I/II期临床试验
[Translation] A Phase I/II clinical trial to evaluate the safety, tolerability and preliminary efficacy of YFQLXB-UC01 injection in the treatment of patients with acute-on-chronic liver failure
Ia期主要目的:评价并确定单次给药治疗慢加急性肝衰竭患者的安全性、耐受性。次要目的:评价单次给药对慢加急性肝衰竭患者的初步有效性;为后续临床试验剂量设计提供依据。探索性研究目的:探索单次给药治疗慢加急性肝衰竭患者的HGF的变化;探索单次给药治疗慢加急性肝衰竭患者的T淋巴细胞分型的变化;探索单次给药治疗慢加急性肝衰竭患者的体液免疫功能变化。
Ib期主要目的:评价并确定多次给药治疗慢加急性肝衰竭患者的安全性、耐受性。次要目的:评价多次给药对慢加急性肝衰竭患者的初步有效性;为后续临床试验剂量设计提供依据。探索性研究目的:探索多次给药治疗慢加急性肝衰竭患者的HGF的变化;探索多次给药治疗慢加急性肝衰竭患者的T淋巴细胞分型的变化;探索多次给药治疗慢加急性肝衰竭患者的体液免疫功能变化。
II期主要研究目的:评价治疗慢加急性肝衰竭患者的初步有效性。次要研究目的:评价并确定治疗慢加急性肝衰竭患者的安全性、耐受性。
[Translation] The main purpose of Phase Ia is to evaluate and determine the safety and tolerability of single-dose treatment for patients with acute-on-chronic liver failure. Secondary purpose: To evaluate the preliminary effectiveness of single-dose treatment for patients with acute-on-chronic liver failure; to provide a basis for the design of subsequent clinical trial doses. Exploratory study objectives: To explore the changes in HGF in patients with acute-on-chronic liver failure after single-dose treatment; to explore the changes in T lymphocyte typing in patients with acute-on-chronic liver failure after single-dose treatment; to explore the changes in humoral immune function in patients with acute-on-chronic liver failure after single-dose treatment.
The main purpose of Phase Ib is to evaluate and determine the safety and tolerability of multiple-dose treatment for patients with acute-on-chronic liver failure. Secondary purpose: To evaluate the preliminary effectiveness of multiple-dose treatment for patients with acute-on-chronic liver failure; to provide a basis for the design of subsequent clinical trial doses. Exploratory study objectives: To explore the changes in HGF in patients with acute-on-chronic liver failure after multiple-dose treatment; to explore the changes in T lymphocyte typing in patients with acute-on-chronic liver failure after multiple-dose treatment; to explore the changes in humoral immune function in patients with acute-on-chronic liver failure after multiple-dose treatment.
The main purpose of Phase II is to evaluate the preliminary effectiveness of treating patients with acute-on-chronic liver failure. Secondary study objective: To evaluate and determine the safety and tolerability of the treatment of patients with acute-on-chronic liver failure.
100 Clinical Results associated with Human Umbilical Cord Mesenchymal Stem Cell(Qilu Cell Therapy)
100 Translational Medicine associated with Human Umbilical Cord Mesenchymal Stem Cell(Qilu Cell Therapy)
100 Patents (Medical) associated with Human Umbilical Cord Mesenchymal Stem Cell(Qilu Cell Therapy)
100 Deals associated with Human Umbilical Cord Mesenchymal Stem Cell(Qilu Cell Therapy)