This study is a prospective, single-arm, dose-escalation exploratory clinical trial to investigate the safety, tolerability and preliminary efficacy of REGEND007 stem cell preparation administered by intravenous infusion in the treatment of idiopathic pulmonary fibrosis (IPF), with a follow-up period of 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
This study's intravenous infusion dose escalation protocol is based on a 3+3 dose escalation design, with a total of 4 dose groups. Each group included 3 subjects, and the dose is gradually increased until the maximum tolerated dose(MTD) or the maximum administered dose (MAD) is reached.
The Fourth Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China
The incidence and severity of drug-related adverse events (AEs)
All adverse medical events that occur from the time the subject signs the informed consent form. These can manifest as symptoms, signs, diseases, or abnormal laboratory test results, but they do not necessarily have a causal relationship with the investigational drug.
Time frame: 12 weeks after the administration
The change in the actual forced vital capacity (FVC) compared to the baseline
FVC is the full amount of air that can be-exhaled with effort in a complete breath
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration
The change in forced vital capacity (FVC) actual-to-predicted ratio compared to the baseline
The FVC actual-to-predicted ratio is a crucial indicator in pulmonary function tests, and it is mainly used to determine whether there is restrictive ventilation dysfunction.
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.
The change in the actual forced expiratory volume in one second (FEV1) compared to the baseline
FEV1 is the volume of breath exhaled with effort in one second.
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration
The change in the forced expiratory volume in one second (FEV1) actual-to-predicted ratio compared to the baseline
The FEV1 actual-to-predicted ratio is a crucial indicator in pulmonary function tests, representing the percentage relationship between the actual measured value of the first-second forced expiratory volume (FEV1) and the predicted value calculated based on individual characteristics. Under normal circumstances, the actual measured value of FEV1 should reach more than 80% of the predicted value.
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Time frame: 24 hours after administration, 4 and 12 weeks after the last administration
The change in the carbon monoxide diffusion capacity (DLCO) compared to the baseline
DLCO is a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration
The change in carbon monoxide diffusion capacity (DLCO) actual-to-predicted ratio compared to the baseline
DLCO actual-to-predicted ratio is a crucial indicator in pulmonary function testing, used to assess the oxygen exchange capacity and efficiency of the alveoli.
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.
The change in the ratio of carbon monoxide diffusion capacity to lung alveolar volume (DLCO/VA) compared to the baseline
DLCO/VA is also known as the diffusion constant, since the diffusion amount is affected by the alveolar ventilation volume, a decrease in alveolar ventilation volume can lead to a reduction in DLCO. Therefore, this value is often used for correction to eliminate the influence of lung volume on the diffusion amount.
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.
The change in the six-minute walk test (6MWT) compared to the baseline
6MWT is one of the commonly used methods in clinical practice for assessing a patient's cardiac and pulmonary functions, which involves measuring the distance that a patient can walk quickly on a flat and hard surface within 6 minutes.
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.
The time when the first acute exacerbation of IPF occurred after administration
The time when the first acute exacerbation of IPF occurred after administration is helpful for assessing disease progression and prognosis.
Time frame: Within 12 weeks after administration