A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)

Regend Therapeutics

Status and phase

Completed

Phase 2

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Biological: Placebo

Biological: REGEND001

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06081621

REGEND001-IPF-231-V1.3

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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 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.