Actively Recruiting
Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy
Led by Regend Therapeutics · Updated on 2026-03-23
12
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gender is not restricted; age between 40 and 80 years old (inclusive)
- Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in 2025
- Six-minute walk test distance between 150 meters and less than 600 meters during screening
- Able to voluntarily sign informed consent and cooperate with study procedures and report condition changes
You will not qualify if you...
- Female subjects who are pregnant, breastfeeding, or planning pregnancy within one year; male subjects whose spouses plan pregnancy
- Survival period estimated less than one year by investigator
- Current or past malignant tumors except certain low-invasiveness cancers with over five years disease-free survival
- Pneumonia within 4 weeks before screening
- More than 4 moderate to severe acute COPD exacerbations requiring hospitalization within 1 year before screening
- Recent or suspected novel coronavirus infection within 4 weeks before screening
- History of invasive or non-invasive mechanical ventilation at screening
- Active pulmonary tuberculosis, poorly controlled asthma, acute pulmonary embolism, or severe pulmonary hypertension
- Severe non-pulmonary diseases in past 6 months judged unsuitable
- Severe anemia or poorly controlled granulocytopenia or thrombocytopenia
- History of suicidal risk, psychiatric disorders, or epilepsy
- Severe malnutrition
- Severe arrhythmias or significant heart conduction abnormalities
- Participation in other trials with interventions or biological treatments within 4 weeks
- Researchers or related personnel involved in this trial or their family members
- Considered unsuitable by investigator for increased risk or interference with trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Fourth Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China, 322000
Actively Recruiting
Research Team
K
Kai Wang, Professor and Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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