A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
14. september 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
102
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shiyue Li, Professor and Chief Physician
- Telefonnummer: 86-20-83062114
- E-post: lishiyue@188.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. september 2028
Datoer for studieregistrering
Først innsendt
14. september 2026
Først innsendt som oppfylte QC-kriteriene
14. september 2026
Først lagt ut (Faktiske)
18. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REGEND001-COPD-251
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .