A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
2026年9月14日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
102
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Shiyue Li, Professor and Chief Physician
- 電話番号：86-20-83062114
- メール：lishiyue@188.com
研究場所
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Guangdong
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Guangzhou、Guangdong、中国
- The First Affiliated Hospital of Guangzhou Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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;
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in COPD Assessment Test (CAT) score
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2028年9月1日
試験登録日
最初に提出
2026年9月14日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- REGEND001-COPD-251
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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