REGEND007 cell therapy for COPD

An Exploratory Clinical Study on the Intravenous Infusion of REGEND007 (Generic Airway Basal Layer Stem Cells) for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

This trial will test whether an intravenous infusion of REGEND007 airway basal cells is safe and can help adults aged 40–80 with COPD improve breathing and exercise capacity.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Regend Therapeutics (Industry-sponsored)
• Locations: 1 site (Yiwu, Zhejiang)
• Trial ID: NCT07355868 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, early phase 1 dose-escalation study that gives escalating doses of REGEND007 airway basal cells by intravenous infusion to people with COPD. The main goals are to measure safety and tolerability and to look for early signs of benefit on lung function and exercise capacity. The study will use the results to recommend appropriate doses for later trials. It is sponsored by Regend Therapeutics and conducted at the Fourth Hospital of Zhejiang University School of Medicine in Yiwu.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40–80 with a GOLD diagnosis of COPD who can walk between 150 and 600 meters on the six-minute walk test and can give informed consent and comply with study procedures.

Not a fit: Patients unlikely to benefit include those with life expectancy under one year, current or past malignant tumors, pregnant or breastfeeding women, or people unable to meet the walking-distance or other eligibility requirements.

Why it matters

Potential benefit: If successful, REGEND007 could help regenerate damaged lung tissue, improving breathing, exercise tolerance, and potentially slowing COPD progression.

How similar studies have performed: While various cell therapies (for example mesenchymal cell approaches) have shown limited or mixed signals in COPD, airway basal cell regenerative therapy is a novel approach with very limited human data to date.

Eligibility criteria

Inclusion 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 complete manner.

Exclusion Criteria:

* 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.
* Subjects who have experienced more than 4 episodes of moderate to severe acute exacerbation of COPD and required hospitalization within 1 year before screening.
* Subjects 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 (manifesting symptoms such as fever, headache, fatigue, joint pain, runny nose, sore throat, and persistent cough, and the disease course is consistent with the prevalent strain) within 4 weeks before screening.
* Subjects with a history of invasive or non-invasive mechanical ventilation at the time of screening.
* Subjects evaluated by the investigator at the time of screening have active pulmonary tuberculosis, poorly controlled bronchial asthma, acute pulmonary embolism, severe pulmonary hypertension \[cardiac ultrasound examination \> 70 mmHg\], etc.
* Subjects 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, acute myocardial infarction, unstable angina pectoris, NYHA heart failure grade III/IV, stroke, liver cirrhosis with severe liver dysfunction, severe renal insufficiency, etc.
* Subjects with severe anemia, or controlled poorly granulocytopenia or thrombocytopenia at the time of screening.
* Subjects with a history of suicidal risk, psychiatric history or epilepsy history at the time of screening.
* Subjects with severe malnutrition at the time of screening.
* Subjects 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 the heart.
* Subjects 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.
* Subjects considered by the investigator to be unsuitable for participation in the trial (increasing the risk of the subjects or interfering with the clinical trial).

Where this trial is running

Yiwu, Zhejiang

• The Fourth Hospital of Zhejiang University School of Medicine — Yiwu, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Kai Wang, Professor and Chief Physician

Conditions Chronic Obstructive Pulmonary Disease