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2023年12月11日

适应症Idiopathic Pulmonary Fibrosis

干预措施REGEND001 Placebo

概览

阶段: 2 期
干预措施: REGEND001
疾病 / 适应症: Idiopathic Pulmonary Fibrosis
发起方: Regend Therapeutics
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.
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2023年12月11日

结束日期

2025年3月14日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Regend Therapeutics

责任方

Sponsor

入排标准

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

干预措施: REGEND001

Placebo

干预措施: Placebo

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.