A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
14 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
102
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Shiyue Li, Professor and Chief Physician
- Telefoonnummer: 86-20-83062114
- E-mail: lishiyue@188.com
Studie Locaties
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Guangdong
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Guangzhou, Guangdong, China
- The First Affiliated Hospital of Guangzhou Medical University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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;
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Placebo
Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.
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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.
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Experimenteel: REGEND001
Participants randomized to the experimental arm will receive a single administration of REGEND001.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
Tijdsspanne: Week 52 after treatment
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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.
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Week 52 after treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in COPD Assessment Test (CAT) score
Tijdsspanne: Week 12, 24 and 52 after treatment
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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.
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score
Tijdsspanne: Week 12, 24 and 52 after treatment
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Minimal clinically important difference for CAT is recognized as 2 points.
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Week 12, 24 and 52 after treatment
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Change from baseline in DLCO
Tijdsspanne: Week 12, 24 and 52 after treatment
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DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured/predicted ratios and corresponding area under curve (AUC).
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO
Tijdsspanne: Week 12, 24 and 52 after treatment
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Minimal clinically important difference (MCID) of DLCO is recognized as 11%.
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Week 12, 24 and 52 after treatment
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Change from baseline in alveolar volume (VA)
Tijdsspanne: Week 12, 24 and 52 after treatment
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VA is assessed by measured values, measured/predicted ratio and corresponding area under curve (AUC).
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Week 12, 24 and 52 after treatment
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Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator
Tijdsspanne: Week 12, 24 and 52 after treatment
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FEV1 is assessed by measured value, measured/predicted ratio and corresponding area under curve (AUC).
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Week 12, 24 and 52 after treatment
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Change from baseline in 6-minute walk distance (6MWD)
Tijdsspanne: Week 12, 24 and 52 after treatment
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6MWD is assessed by the measured value and corresponding area under curve
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥30-meter change from baseline in 6MWD
Tijdsspanne: Week 12, 24 and 52 after treatment
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Minimal clinically important difference (MCID) of 6MWD is recognized as 30 meters.
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Week 12, 24 and 52 after treatment
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Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score
Tijdsspanne: Week 12, 24 and 52 after treatment
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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.
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score
Tijdsspanne: Week 12, 24 and 52 after treatment
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Minimal clinically important difference for SGRQ is recognized as 4 points.
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Week 12, 24 and 52 after treatment
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Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics
Tijdsspanne: Week 52 after treatment
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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.
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Week 52 after treatment
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Change from baseline in arterial blood gas parameters
Tijdsspanne: Week 52 after treatment
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The change from baseline in arterial blood gas parameters reflects changes in gas exchange function and respiratory status over the assessment period.
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Week 52 after treatment
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Change from baseline in HRCT images
Tijdsspanne: Week 52 after treatment
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HRCT images are quantitatively analyzed using dedicated software to measure emphysema volume (mL) and functional lung volume (mL).
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Week 52 after treatment
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Adverse Event
Tijdsspanne: Hour 24, Week 12, 24 and 52 after treatment
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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.
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Hour 24, Week 12, 24 and 52 after treatment
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 oktober 2026
Primaire voltooiing (Geschat)
1 september 2028
Studie voltooiing (Geschat)
1 september 2028
Studieregistratiedata
Eerst ingediend
14 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
14 september 2026
Eerst geplaatst (Werkelijk)
18 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 september 2026
Laatste update ingediend die voldeed aan QC-criteria
14 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REGEND001-COPD-251
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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