New Trial – Autologous Lung Progenitor Cells for COPD
Regend Therapeutics plans a Phase 3, randomized, blinded, placebo-controlled study enrolling 102 people with COPD and emphysema to assess lung diffusion capacity at 52 weeks.
Trial at a glance
- Sponsor: Regend Therapeutics
- Phase/Status: Phase 3; not yet recruiting
- Indication: COPD patients with emphysema; estimated enrollment of 102 participants
- Arms/Dosing: REGEND001: Enrolled participants will undergo bronchoscopy with brushing for cell collection, followed by a single administration of REGEND001 via bronchoscopy and 1 year of follow-up.
- Control: Placebo: Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single administration of placebo via bronchoscopy and 1 year of follow-up.
- Endpoints: Primary: Change from baseline in measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 52 after treatment. Secondary: Change from baseline in COPD Assessment Test (CAT) score at Weeks 12, 24 and 52 after treatment; adverse events at Hour 24 and Weeks 12, 24 and 52 after treatment.
- Timing: Estimated start: October 2026; estimated primary completion: September 2028; estimated study completion: September 2028.
Trial Summary
ClinicalTrials.gov lists the following summary for the linked study.
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.
- Contact: Shiyue Li, lishiyue@188.com, 86-20-83062114
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