A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulm… (NCT06081621) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)
China23 participantsStarted 2023-12-11
Plain-language summary
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.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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;
Exclusion Criteria:
* 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 …
What they're measuring
1
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.