A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
14 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
102
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Shiyue Li, Professor and Chief Physician
- Numero di telefono: 86-20-83062114
- Email: lishiyue@188.com
Luoghi di studio
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Guangdong
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Guangzhou, Guangdong, Cina
- The First Affiliated Hospital of Guangzhou Medical University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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;
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in COPD Assessment Test (CAT) score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 12, 24 and 52 after treatment
|
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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
1 settembre 2028
Completamento dello studio (Stimato)
1 settembre 2028
Date di iscrizione allo studio
Primo inviato
14 settembre 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 settembre 2026
Primo Inserito (Effettivo)
18 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REGEND001-COPD-251
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .