Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy

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

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 Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Biological: REGEND007

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kai Wang, Professor and Chief Physician; Phone Number: 086-0579-89935016; Email: kaiw@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The Fourth Hospital of Zhejiang University School of Medicine
      • Contact: Shaohua Zhang; Phone Number: 086-0579-89979999; Email: z16zsh@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REGEND007 Cell Therapy	Biological: REGEND007; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 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	Within 12 weeks after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	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.	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.	24 hours after administration, 4 and 12 weeks after the last administration.

Collaborators and Investigators

• Sponsor: Regend Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: REGEND007-COPD-251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No