REGEND001 Autologous Basal Layer Stem Cell Transplantation for Chronic Obstructive Pulmonary Disease (COPD): A Translational Application Study

Обзор

This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous bronchial basal cell therapy, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic respiratory condition characterized by persistent airflow limitation and impaired lung function, leading to significant morbidity and mortality worldwide. Current treatments primarily focus on symptom management and have limited impact on disease progression or survival. This study proposes a novel approach using autologous bronchial basal cells, which have demonstrated the potential to repair damaged lung tissue and improve lung function in preclinical studies. The therapy involves the collection of bronchial basal cells via bronchial brushing, followed by their expansion and reintroduction into the patient's lungs via bronchoscopic infusion. The primary objective is to assess the improvement in lung diffusion capacity (DLCO), with secondary endpoints including changes in lung ventilation function (FEV1, FVC) and quality of life (CAT score). The study will also monitor safety, including the incidence of adverse events. Eligible participants are COPD patients aged 40-80 with moderate to severe disease. The trial includes a screening phase, cell collection, transplantation, and follow-up assessments at 4 and 24 weeks post-treatment. This study represents a promising advancement in regenerative medicine for COPD, offering a potential therapeutic option that addresses the underlying structural damage in the lungs.

Вмешательства

• Биопрепарат P63+ lung progenitors
  1. Patient Screening and Cell Collection: Eligible patients will undergo sample collection at the study center or authorized tertiary hospitals. The operator will collect samples via bronchial brushing from three healthy segments of the patient's 3-5 level bronchi. The samples will be transported to a cooperative production facility for isolation and preparation. The cell preparation cycle is approximately 4-8 weeks. Patients will bear the costs of this process. 2. Transplantation Therapy:

Первичные конечные точки

• Change in DLCO from baseline. [Срок оценки: Baseline, 4 weeks post treatment, 24 weeks post treatment]

Вторичные конечные точки (3)

• Change in FEV1 from baseline. [Срок оценки: Baseline, 4 weeks post treatment, 24 weeks post treatment]
• Change in FVC from baseline. [Срок оценки: Baseline, 4 weeks post treatment, 24 weeks post treatment]
• Improvement in CAT score (symptoms, activity, and psychological status). [Срок оценки: Baseline, 4 weeks post treatment, 24 weeks post treatment]

Критерии участия

Критерии включения

• Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD);
• Post-bronchodilator FEV1/FVC <70%;
• DLCO ≥20% and <80% of predicted value.

Критерии исключения

• Pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant);
• Positive for syphilis (TP-Ab), HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies;
• Current or past history of malignancy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine — Qionghai
• Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06946953 · 20250322

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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