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

ConditionCOPD (Chronic Obstructive Pulmonary Disease)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-75
SponsorRegend Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 40-75 years；

Diagnosed with COPD;

Post-bronchodilator FEV1/FVC <0.7

Emphysematous lesions demonstrated by HRCT;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Biological/Vaccine

    Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of placebo via bronchoscopy and 1 year of follow-up.

  • REGEND001

    Biological/Vaccine

    Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of REGEND001 via bronchoscopy and 1 year of follow-up.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: REGEND001Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）

The change from baseline in measured DLCO is defined as the difference between the absolute measured DLCO value at baseline and that measured at the assessment time point after treatment.

Time frame
Week 52 after treatment

Secondary outcomes

1

Change from baseline in COPD Assessment Test (CAT) score

The COPD Assessment Test (CAT) is an 8-item questionnaire used to assess the impact of COPD on health status. The total score ranges from 0 to 40, with higher scores indicating a greater impact of COPD and worse health status. Change from baseline is calculated as the post-treatment CAT score minus the baseline CAT score.

Time frame
Week 12, 24 and 52 after treatment
2

Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score

Minimal clinically important difference for CAT is recognized as 2 points.

Time frame
Week 12, 24 and 52 after treatment
3

Change from baseline in DLCO

DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured/predicted ratios and corresponding area under curve (AUC).

Time frame
Week 12, 24 and 52 after treatment
4

Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO

Minimal clinically important difference (MCID) of DLCO is recognized as 11%.

Time frame
Week 12, 24 and 52 after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regend Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: