Trial intelligence / Profile preview

REGEND001 in COPD

NCT06946953Phase 2

Key facts

Status
Recruiting
Start
Mar 2025
Primary completion
Dec 2029
Countries
1
Sponsor
Ruijin Hospital
Modality
Stem Cell Therapies
Conditions
chronic obstructive pulmonary disease (COPD)
01

Overview

Phase 2, open-label, single-arm trial of autologous bronchial basal cells in chronic obstructive pulmonary disease (COPD), sponsored by Ruijin Hospital. Primary endpoint: Lung diffusion capacity at 24 weeks. Started Mar 2025; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • COPD patients

    Patients receive a single dose of REGEND001 (P63+ lung progenitors) via bronchoscopic infusion.

03

Who it enrols

COPD patients aged 40-80 with FEV1/FVC <70% and DLCO 20-80% of predicted, excluding those with HIV, syphilis, hepatitis B/C, or a history of malignancy.

04

Endpoints

Primary

  • Lung diffusion capacity

Secondary

  • Forced Expiratory Volume in 1 second

  • Forced Vital Capacity

  • COPD Assessment Test

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