Idiopathic pulmonary fibrosis (IPF) is a condition where the lungs are damaged and scarred with unknown reason, making breathing becomes increasingly difficult.. REGEND001, made from airway basal cells with ability to regenerate lung tissue, is promising to IPF treatment. In this study, a single-armed clinical trial is ongoing to assess the safety and tolerability of REGEND001 in treatment of IPF. Different doses of REGEND001 is evaluated to establish a dose-response relationship and to suggest appropriate dose for subsequent clinical trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Transplantation of REGEND001 for dose escalation.
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Incidence and severity of the cell therapy-related adverse events (AEs)
Dose escalation is based on incidence of cell therapy-related AEs. Severity of cell therapy-related adverse events (AEs) is evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Within 24 weeks after treatment
Incidence of complication related to bronchoscopy
REGEND001 is given to subjects by bronchoscopy. Thus, incidence of complication related to bronchoscopy is adapted to assess the safety of the products.
Time frame: Within 24 weeks after treatment
Change in lung diffusing capacity for single-breath carbon monoxide (DLCO-sb) from baseline
DLCO-sb is measured by the single-breath method. It is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
Time frame: 4, 12 and 24 weeks after treatment
Change in forced vital capacity (FVC) from baseline
FVC indicates the volume of air that can forcibly be blown out after a full inspiration.
Time frame: 4, 12 and 24 weeks after treatment
Change in the ratio of diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA) from baseline
The DLCO test refers to the diffusing capacity for carbon monoxide in the lungs. It is a type of pulmonary function test that helps to assess how well gas is exchanged between the lungs and the bloodstream. Since DLCO is affected by the amount of inhaled gas and lung volume, the alveolar ventilation is considered to exclude the effect of lung volume on diffusion volume in evaluating diffusion function.
Time frame: 4, 12 and 24 weeks after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in 6-minute-walk test (6MWT) from baseline
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: 4, 12 and 24 weeks after treatment
Change in St. George's Respiratory Questionnaire (SGRQ) scale from baseline
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: 4, 12 and 24 weeks after treatment
Change in lung imags of high resolution computed tomography (HRCT) from baseline
Lung images from HRCT will be analyzed to indicate the newly-derived pulmonary structure.
Time frame: 24 weeks after treatment
Acute exacerbation of idiopathic pulmonary fibrosis (IPF)
Frequency and severity of acute exacerbation of IPF will be evaluated.
Time frame: Within 24 weeks after treatment
Change in blood routine from baseline
Number of cases or participants with abnormal laboratory test results will be evaluated.
Time frame: Within 24 weeks after treatment.
Change in urine routine from baseline
Number of cases or participants with abnormal laboratory test results will be evaluated.
Time frame: Within 24 weeks after treatment.
Change in blood biochemistry from baseline
Number of cases or participants with abnormal laboratory test results will be evaluated.
Time frame: Within 24 weeks after treatment
Change in 12-lead Electrocardiogram (ECG) from baseline
Number of cases or participants with abnormal results wil be evaluated
Time frame: Within 24 weeks after treatment
Change in carcinoembryonic antigen (CEA) from baseline
CEA is a tumor marker used for early diagnosis of lung cancer.
Time frame: 12 and 24 weeks after treatment
Change in neuron-specific enolase (NSE) from baseline
NSE is a tumor marker significantly elevated in small cell lung cancer.
Time frame: 12 and 24 weeks after treatment
Change in cytokeratin-19-fragment (CYFRA21-1) from baseline
CYFRA21-1 is a tumor marker which has important value for the pathological classification and prognosis evaluation of lung cancer.
Time frame: 12 and 24 weeks after treatment
Change in squamous cell carcinoma antigen (SCC) from baseline
SCC is a specific marker for lung squamous cell carcinoma. Tumor markers are monitored to assess the safety.
Time frame: 12 and 24 weeks after treatment