A Phase 2 interventional study of REGEND001 and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by Regend Therapeutics. Completed at 4 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Regend Therapeutics · Phase 2, Interventional, and Treatment
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.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's enrollment of 23 is below the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Regend Therapeutics is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: REGEND001
Biological: Placebo
REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy.
Placebo: Sodium chloride injection administrated by bronchoscopy.
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
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
Change from baseline in lung ventilatory capacity
Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) will be used to evaluate the lung ventilatory capacity. FVC indicates the volume of air that can forcibly be blown out after full inspiration. FEV1 is the volume of breath exhaled with effort in one second.
Time frame: 12 and 24 weeks after treatment
Progression-free survival (PFS)
PFS refers to the time from randomization or initiation of treatment to the occurrence of disease progression or death.
Time frame: Within 24 weeks after treatment
Change from baseline in St. George's respiratory questionnaire (SGRQ) scale
Quality of life was assessed by St. George's respiratory questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.
Time frame: 12 and 24 weeks after treatment
Change from baseline in 6-minute-walk test (6MWT)
The 6MWT is a commonly used test for the objective assessment of functional exercise capacity by testing the distance patients can walk at the fastest speed within 6 minutes.
Time frame: 12 and 24 weeks after treatment
Time from enrollment to all-cause death
Time from enrollment to all-cause death is used to evaluate the overall survival of the population.
Time frame: up to 24 weeks(first period), 5 years (second period).
Blood oxygen saturation
Blood oxygen saturation is the measure of how much oxygen is traveling through body in red blood cells.
Time frame: 12 and 24 weeks after treatment
Change from baseline in images of lung by high resolution computed tomography (HR-CT)
HR-CT images of lung will be analyzed to indicate the change of pulmonary structure.
Time frame: 12 and 24 weeks after treatment
Change from baseline in C-reactive protein (CRP)
The level of CRP increases when there's inflammation in the body.
Time frame: 12 and 24 weeks after treatment
Time to acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF)
AE-IPF is an often deadly complication of IPF, which is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality.
Time frame: Within 24 weeks after treatment
Temperature
Number of cases with abnormal body temperature.
Time frame: Within 24 weeks after treatment
Breathing
Number of cases with abnormal breathing.
Time frame: Within 24 weeks after treatment
Pulse
Number of cases with abnormal pulse.
Time frame: Within 24 weeks after treatment
Blood pressure
Number of cases with abnormal blood pressure.
Time frame: Within 24 weeks after treatment
Symptoms, physical examination
Number of cases with abnormal physical examination
Time frame: Within 24 weeks after treatment
12-lead ECG
Number of cases with abnormal 12-lead Electrocardiogram (ECG).
Time frame: Within 24 weeks after treatment
Blood routine
Number of cases with abnormal laboratory test results
Time frame: Within 24 weeks after treatment
Liver & Kidney function check
Number of cases with abnormal results in Liver \& Kidney function check
Time frame: Within 24 weeks after treatment
Blood glucose
Number of cases with abnormal results
Time frame: Within 24 weeks after treatment
Function of blood clotting
Number of cases with abnormal function of blood clotting.
Time frame: Within 24 weeks after treatment
Antibody testing for autoimmune diseases
Antibodies related to autoimmune diseases are tested for safety assessment
Time frame: Within 24 weeks after treatment
Carcinoembryonic antigen (CEA)
CEA is a tumor marker used for early diagnosis of lung cancer.Clinically significant changes of this markers will be assessed.
Time frame: Within 24 weeks after treatment
Neuron-specific enolase (NSE)
NSE is a tumor marker significantly elevated in small cell lung cancer. Clinically significant changes of this marker will be assessed
Time frame: Within 24 weeks after treatment
Cytokeratin-19-fragment (CYFRA21-1)
CYFRA21-1 is a tumor marker which is valuable for the pathological classification and prognosis evaluation of lung cancer. Clinically significant changes of this marker will be assessed
Time frame: Within 24 weeks after treatment
Squamous cell carcinoma antigen (SCC)
SCC is a specific marker for lung squamous cell carcinoma. Clinically significant changes of this marker will be assessed
Time frame: Within 24 weeks after treatment
Other cases of adverse effects
Other cases of adverse effects will be recorded and compared.
Time frame: Within 24 weeks after treatment
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis→
Regend Therapeutics