A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
14. september 2026 opdateret af: Regend Therapeutics
A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
102
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Shiyue Li, Professor and Chief Physician
- Telefonnummer: 86-20-83062114
- E-mail: lishiyue@188.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.
|
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.
|
|
Eksperimentel: REGEND001
Participants randomized to the experimental arm will receive a single administration of REGEND001.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
Tidsramme: Week 52 after treatment
|
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.
|
Week 52 after treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in COPD Assessment Test (CAT) score
Tidsramme: Week 12, 24 and 52 after treatment
|
The change from baseline in CAT score is defined as the difference between the CAT score at baseline and the CAT score measured at the specified post-treatment assessment time point.
|
Week 12, 24 and 52 after treatment
|
|
Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score
Tidsramme: Week 12, 24 and 52 after treatment
|
Minimal clinically important difference for CAT is recognized as 2 points.
|
Week 12, 24 and 52 after treatment
|
|
Change from baseline in DLCO
Tidsramme: Week 12, 24 and 52 after treatment
|
DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured/predicted ratios and corresponding area under curve (AUC).
|
Week 12, 24 and 52 after treatment
|
|
Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO
Tidsramme: Week 12, 24 and 52 after treatment
|
Minimal clinically important difference (MCID) of DLCO is recognized as 11%.
|
Week 12, 24 and 52 after treatment
|
|
Change from baseline in alveolar volume (VA)
Tidsramme: Week 12, 24 and 52 after treatment
|
VA is assessed by measured values, measured/predicted ratio and corresponding area under curve (AUC).
|
Week 12, 24 and 52 after treatment
|
|
Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator
Tidsramme: Week 12, 24 and 52 after treatment
|
FEV1 is assessed by measured value, measured/predicted ratio and corresponding area under curve (AUC).
|
Week 12, 24 and 52 after treatment
|
|
Change from baseline in 6-minute walk distance (6MWD)
Tidsramme: Week 12, 24 and 52 after treatment
|
6MWD is assessed by the measured value and corresponding area under curve
|
Week 12, 24 and 52 after treatment
|
|
Proportion of subjects with a ≥30-meter change from baseline in 6MWD
Tidsramme: Week 12, 24 and 52 after treatment
|
Minimal clinically important difference (MCID) of 6MWD is recognized as 30 meters.
|
Week 12, 24 and 52 after treatment
|
|
Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score
Tidsramme: Week 12, 24 and 52 after treatment
|
The St. George's Respiratory Questionnaire for COPD (SGRQ-C) is a validated disease-specific patient-reported outcome measure used to assess the impact of COPD on patients' health status and quality of life.
Total score, ranged from 0 to 100, is the sum of points from all items.
A higher value represents a worse outcome.
|
Week 12, 24 and 52 after treatment
|
|
Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score
Tidsramme: Week 12, 24 and 52 after treatment
|
Minimal clinically important difference for SGRQ is recognized as 4 points.
|
Week 12, 24 and 52 after treatment
|
|
Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics
Tidsramme: Week 52 after treatment
|
The annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics, represents the adjusted frequency of acute exacerbations of COPD over the assessment period.
|
Week 52 after treatment
|
|
Change from baseline in arterial blood gas parameters
Tidsramme: Week 52 after treatment
|
The change from baseline in arterial blood gas parameters reflects changes in gas exchange function and respiratory status over the assessment period.
|
Week 52 after treatment
|
|
Change from baseline in HRCT images
Tidsramme: Week 52 after treatment
|
HRCT images are quantitatively analyzed using dedicated software to measure emphysema volume (mL) and functional lung volume (mL).
|
Week 52 after treatment
|
|
Adverse Event
Tidsramme: Hour 24, Week 12, 24 and 52 after treatment
|
An adverse event (AE) is any untoward medical occurrence in a subject who has received a study intervention, regardless of whether or not it is considered related to the intervention.
|
Hour 24, Week 12, 24 and 52 after treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. september 2028
Studieafslutning (Anslået)
1. september 2028
Datoer for studieregistrering
Først indsendt
14. september 2026
Først indsendt, der opfyldte QC-kriterier
14. september 2026
Først opslået (Faktiske)
18. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REGEND001-COPD-251
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .