Idiopathic Pulmonary Fibrosis
Conditions
Brief 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.
Interventions
BIOLOGICALREGEND001
REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy.
BIOLOGICALPlacebo
Placebo: Sodium chloride injection administrated by bronchoscopy.
Sponsors
Regend Therapeutics
Peking Union Medical College Hospital
RenJi Hospital
Ruijin Hospital
The Second Affiliated Hospital of Xiamen Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 and 24 weeks after treatment | DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in lung diffusing capacity | 12 and 24 weeks after treatment | 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. |
Countries
China
Outcome results
None listed