A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
14 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
102
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Shiyue Li, Professor and Chief Physician
- Telefonnummer: 86-20-83062114
- E-post: lishiyue@188.com
Studieorter
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Guangdong
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Guangzhou, Guangdong, Kina
- The First Affiliated Hospital of Guangzhou Medical University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline in COPD Assessment Test (CAT) score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 september 2028
Avslutad studie (Beräknad)
1 september 2028
Studieregistreringsdatum
Först inskickad
14 september 2026
Först inskickad som uppfyllde QC-kriterierna
14 september 2026
Första postat (Faktisk)
18 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REGEND001-COPD-251
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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