NCT06081621已完成2 期
A Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy in Idiopathic Pulmonary Fibrosis (IPF) Patients
Regend Therapeutics7 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年12月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- Comparison of the area under the curve (AUC) of DLCO measured values at each visit from baseline to week 24 between the REGEND001 group and the placebo group.
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 40 to 75;
- •Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathic pulmonary fibrosis 2022 edition;
- •Subjects with DLCO (measured/predicted value) ≥30% and <80%, and FVC (measured/predicted value) ≥50% within 3 months prior to screening
- •Subjects tolerant to bronchofiberscope;
- •Subjects tolerant to test of lung function;
- •Subjects able to voluntarily sign the informed consent and cooperate with the completion of pulmonary function tests;
排除标准
- •Female subject who is pregnant, nursing, or planning to be pregnant in half a year after using this product (or male subjects planning to have a pregnant spouse);
- •At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test, except the following: (1) Hepatitis B virus carriers (only HBsAg positive, no hepatitis symptoms and signs, all liver function tests are normal); (2) Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test.
- •Subject with malignant tumors or a history of malignant tumors;
- •Subject with severe anemia, poorly controlled agranulocytosis and thrombocytopenia at screening;
- •Subject at risk of suicide or has a history of mental illness or epilepsy at the time of screening;
- •Subject with severe arrhythmias or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG);
- •Subject who participated in other interventional clinical trials in the past 3 months;
- •Subject assessed as inappropriate to participate in this clinical trial by investigators.
研究组 & 干预措施
REGEND001
Experimental
干预措施: REGEND001 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
Comparison of the area under the curve (AUC) of DLCO measured values at each visit from baseline to week 24 between the REGEND001 group and the placebo group.
时间窗: 12 and 24 weeks after treatment
DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline.
次要结局
- Change from baseline in lung diffusing capacity(12 and 24 weeks after treatment)
研究者
研究点 (7)
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