A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Regend Therapeutics

Status and phase: Not yet enrolling; Phase 3

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Biological: REGEND001; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07828353

REGEND001-COPD-251

Details and patient eligibility

About

Chronic obstructive pulmonary disease (COPD) is a common, progressive, and heterogeneous respiratory disorder. It is associated with substantial morbidity and mortality worldwide, leading to progressive decline in lung function, impaired quality of life, and a significant healthcare burden. REGEND001, made from airway basal stem cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, blinded, placebo-parallel-controlled trial is performed to verify the efficacy and safety of REGEND001 in treatment of COPD patients with emphysema.

Enrollment: 102 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 40-75 years；
• Diagnosed with COPD;
• Post-bronchodilator FEV1/FVC <0.7
• Emphysematous lesions demonstrated by HRCT;
• Hemoglobin-corrected DLCO%predicted ≥20% and <70%;
• Post-bronchodilator FEV1%predicted ≤80%;
• COPD Assessment Test (CAT) score ≥3;

Exclusion criteria

• History of ≥2 COPD exacerbations leading to hospitalization within 1 year prior to screening, or a COPD exacerbation leading to hospitalization within 2 months prior to screening;
• Current or previous history of malignancy;
• An assessed life expectancy of <1 year;
• Respiratory tract infection or systemic infection requiring treatment, or severe localized infection within 4 weeks prior to screening;
• History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening;
• Diagnosis of pneumonia within 3 months prior to screening;
• Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at screening;
• Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet therapy, who are unable to discontinue such medications for at least 1 week prior to cell collection and cell infusion;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

102 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.

Treatment:

Biological: Placebo

REGEND001

Experimental group

Description:

Participants randomized to the experimental arm will receive a single administration of REGEND001.

Treatment:

Biological: REGEND001