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New treatment option for Chronic Obstructive Pulmonary Disease (COPD)
Official title Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy
ClinicalTrials.gov ID: NCT07355868
What this study is testing
What is REGEND007?
REGEND007 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic obstructive pulmonary disease (copd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
You likely can't join if
- Female people who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male people whose spouses...
- people evaluated by the investigator at the time of screening have a survival period of less than one year.
- people with a current or past history of malignant tumors (excluding non-melanoma skin cancer, cervical cancer in situ, bladder cancer, thyroid...
- people diagnosed with pneumonia (including bacterial, fungal, or viral pneumonia) within 4 weeks before screening.
- people who have experienced more than 4 episodes of moderate to severe acute exacerbation of COPD and required hospitalization within 1 year before...
- people who have one or more results of pathogen or serological tests (nucleic acid, antigen, virus culture, specific IgG antibody levels) reporting...
See the full eligibility criteria
- 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...
- Female people who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male people whose spouses are planning to become pregnant.
- people evaluated by the investigator at the time of screening have a survival period of less than one year.
- people 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...
- people diagnosed with pneumonia (including bacterial, fungal, or viral pneumonia) within 4 weeks before screening.
- people who have experienced more than 4 episodes of moderate to severe acute exacerbation of COPD and required hospitalization within 1 year before screening.
- people who have one or more results of pathogen or serological tests (nucleic acid, antigen, virus culture, specific IgG antibody levels) reporting novel coronavirus infection, or suspected novel coronavirus infection...
- people with a history of invasive or non-invasive mechanical ventilation at the time of screening.
- people evaluated by the investigator at the time of screening have active pulmonary tuberculosis, poorly controlled bronchial asthma, acute pulmonary embolism, severe pulmonary hypertension [cardiac ultrasound...
- people with severe non-pulmonary systemic diseases within 6 months before screening and evaluated by the investigator as not suitable to participate in this study, such as diabetic ketoacidosis or hyperosmolar coma...
- people with severe anemia, or controlled poorly granulocytopenia or thrombocytopenia at the time of screening.
- people with a history of suicidal risk, psychiatric history or epilepsy history at the time of screening.
- people with severe malnutrition at the time of screening.
- people with 12-lead electrocardiogram showing severe arrhythmias (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or abnormal conduct at II degree and above of...
- people who have participated in other clinical trials with intervention measures or received other biological agent treatment within 4 weeks before screening.
- Researchers, collaborating researchers, research coordinators, researchers participating in the study, or employees of the research center or their family members of the aforementioned personnel.
- people considered by the investigator to be unsuitable for participation in the trial (increasing the risk of the people or interfering with the clinical trial).
The study team makes the final eligibility decision.
Where it's taking place
- Yiwu, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yiwu, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.