Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorRegend Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
Gender is not restricted; when signing the informed consent form, the age should be between 40 and 80 years old (inclusive of the boundary values);
Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in 2025;
During the screening process, the six-minute walk test should be ≥ 150 meters and < 600 meters;
Voluntarily sign the informed consent form, be able to cooperate with the completion of the research-related procedures and examinations, and be able to describe or record the changes in the condition in a relatively complete manner.
Disqualifiers
Female subjects who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male subjects whose spouses are planning to become pregnant.
Subjects evaluated by the investigator at the time of screening have a survival period of less than one year.
Subjects with a current or past history of malignant tumors (excluding non-melanoma skin cancer, cervical cancer in situ, bladder cancer, thyroid cancer, and breast cancer, etc., which have a disease-free survival of more than five years and are judged by the investigator to have a relatively weak invasiveness) at the time of screening.
Subjects diagnosed with pneumonia (including bacterial, fungal, or viral pneumonia) within 4 weeks before screening.
Trial design
Treatments tested in this trial
- REGEND007
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov