Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND007 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. A prospective, single-arm, dose-escalation exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of different doses of REGEND007 cell therapy administered by intravenous infusion in the treatment of COPD, and to recommend appropriate treatment doses for subsequent clinical studies.
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
RECRUITINGThe 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: Within 12 weeks after administration
The time of the first occurrence of acute exacerbation of COPD (AECOPD) after administration
The time of the first occurrence of acute exacerbation of COPD (AECOPD) after administration is an important indicator for assessing the severity and prognosis of the disease.
Time frame: Within 12 weeks after the last administration
The changes in the annual incidence of AECOPD after administration compared to before administration
The changes in the annual incidence of AECOPD after administration compared to before administration is an important indicator for assessing the severity and prognosis of the disease.
Time frame: 12 weeks after administration
The change in the forced vital capacity (FVC) actual-to-predicted ratio compared to baseline
FVC is the full amount of air that can beexhaled with effort in a complete breath
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration
The changes in forced expiratory volume in one second (FEV1) actual-to-predicted ratio compared to 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 changes in the carbon monoxide diffusion capacity (DLCO) actual-to-predicted ratio compared to 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.
Ratio of DLCO to lung volume (DLCO/VA))
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 changes in the six-minute walk test (6MWT) compared to 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 changes in the COPD assessment test (CAT) compared to the baseline.
CAT is a self-completed questionnaire tool by the patients, used to assess the extent to which the condition of chronic obstructive pulmonary disease affects their quality of life.
Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.
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