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

Regend Therapeutics23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

REGEND001BIOLOGICAL

REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy.

PlaceboBIOLOGICAL

Placebo: Sodium chloride injection administrated by bronchoscopy.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (4)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, China

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, Shanghai Municipality, China

Renji Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline.

Time frame: 12 and 24 weeks after treatment

Secondary Outcomes

Change from baseline in lung diffusing capacity

DLCO will be used to evaluate the lung diffusing capacity. DLCO test refers to the diffusing capacity for carbon monoxide in the lungs. It's a type of pulmonary function test that helps to assess how well gas is exchanged between the lungs and the bloodstream.

Time frame: 12 and 24 weeks after treatment

Data from ClinicalTrials.gov

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