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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• The incidence and severity of drug-related adverse events (AEs) [Срок оценки: Within 12 weeks after administration]

Вторичные конечные точки (8)

• The time of the first occurrence of acute exacerbation of COPD (AECOPD) after administration [Срок оценки: Within 12 weeks after the last administration]
• The changes in the annual incidence of AECOPD after administration compared to before administration [Срок оценки: 12 weeks after administration]
• The change in the forced vital capacity (FVC) actual-to-predicted ratio compared to baseline [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 24 hours after administration, 4 and 12 weeks after the last administration.]
• Ratio of DLCO to lung volume (DLCO/VA)) [Срок оценки: 24 hours after administration, 4 and 12 weeks after the last administration.]
• The changes in the six-minute walk test (6MWT) compared to baseline [Срок оценки: 24 hours after administration, 4 and 12 weeks after the last administration.]
• The changes in the COPD assessment test (CAT) compared to the baseline. [Срок оценки: 24 hours after administration, 4 and 12 weeks after the last administration.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Fourth Hospital of Zhejiang University School of Medicine — Yiwu

Идентификаторы

NCT: NCT07355868 · REGEND007-COPD-251

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗