Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
調査の概要
詳細な説明
The purpose of the Lung Institute is to collect, minimally process, and administer a person's own stem cells and/or platelet rich plasma and deliver the product back to the patient same-day through an intravenous catheter. This study is limited to patients diagnosed with chronic obstructive pulmonary disease (COPD) and is a double-blinded prospective, cohort trial using cross-over methodology. The aim of this study is to determine if stem cell therapy is better than placebo among a group of patients with COPD.
50 participants will be recruited for each arm of the study.
Cohort A will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.
Cohort B will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Dallas、Texas、アメリカ、75231
- Lung Institute Dallas
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of Lung Institute who determines final eligibility for inclusion. Patients must be diagnosed with chronic obstructive pulmonary disease (COPD) and be able to travel to the Dallas clinic location.
Exclusion Criteria:
- Patients who are unable to provide informed consent, pregnant patients, prisoners, non-English speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. Patients without a documented COPD diagnosis are excluded.
研究計画
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：クロスオーバー割り当て
- 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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実験的：Cohort A
Cohort A (Treatment Then Placebo group) will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application).
Cohort A will return in three months and receive three consecutive days of placebo.
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Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.
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実験的：Cohort B
Cohort B (Placebo Then Treatment group) will receive three consecutive days of placebo.
Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.
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Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.
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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 in Quality of Life Score
時間枠：3 months, 6 months following each treatment
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Change in QOL score from baseline to 3 months and 6 months following each treatment
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3 months, 6 months following each 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 in FEV1
時間枠：6 months following each treatment
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Change in FEV1 from baseline to 6 months post-treatment
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6 months following each treatment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
COPDの臨床試験
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Istituto Nazionale di Ricovero e Cura per Anziani募集
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Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre de Validació...まだ募集していません
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University Hospital, Brest募集
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The First Affiliated Hospital of Guangzhou Medical...募集
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Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)募集
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Baylor Research Instituteまだ募集していません
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Polytechnic Institute of PortoNippon Gases Portugal募集
Treatment Then Placeboの臨床試験
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Washington State UniversityNational Institute on Drug Abuse (NIDA)完了
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Palacky University完了
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Reistone Biopharma Company Limited完了