急性呼吸窮迫症候群（ARDS）と診断された患者における、研究用臍帯由来間葉系幹細胞療法JadiCell™の安全性と潜在的な治療効果を評価すること。
JadiCell™（臍帯由来間葉系幹細胞）による急性呼吸窮迫症候群（ARDS）治療の第III相臨床試験
This study evaluates the safety and potential therapeutic activity of JadiCell™, an investigational umbilical cord-derived mesenchymal stem cell therapy, in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). JadiCells are administered intravenously and are intended to modulate inflammatory responses and promote tissue repair in injured lung tissue.
調査の概要
状態
条件
詳細な説明
Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by severe inflammatory lung injury, impaired oxygen exchange, and high mortality. Current treatments are primarily supportive and include mechanical ventilation and intensive care management.
JadiCell™ is an investigational cellular therapy derived from human umbilical cord tissue. These cells possess immunomodulatory and regenerative properties and may reduce inflammatory lung injury through paracrine signaling, immune regulation, and tissue repair mechanisms.
Following intravenous administration, mesenchymal stem cells are known to localize within the pulmonary microvasculature where they interact with immune cells and injured lung tissue.
This study will evaluate the safety and potential clinical effects of intravenous JadiCell administration in patients with ARDS.
研究の種類
入学 (推定)
段階
- フェーズ 3
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 currently hospitalized
- Laboratory confirmation of ARDS
- Aged between 18 and 80 years
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- SpO2 <94% on room air requiring supplemental oxygen above baseline
- PaO2/FiO2 <300 mmHg
- Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
- Requiring one of the following ï High Flow Oxygen Therapy ï Non-invasive Positive Pressure Ventilation (NIPPV, e.g. BiPAP and CPAP) ï Invasive Mechanical Ventilation (INV = intubated)
Exclusion Criteria:
- Greater than 96 h since hospitalization at the time of enrollment
- Greater than 48 h since intubation at the time of enrollment
- A previous MSC infusion not related to this trial
- History of Pulmonary Hypertension (WHO Class III/IV)
- History of left atrial hypertension or decompensated left heart failure.
- Pregnant or lactating patient
- Unstable arrhythmia
- Patients currently receiving immunosuppression with exception of up to 10 mg Prednisone equivalents daily
- Patients currently receiving chronic dialysis
- Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
- Presence of any active malignancy (except non-melanoma skin cancer)
- Moderate to severe liver disease (AST and ALT >5 X ULN)
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen at rest
- Septic Shock (with >1 vasopressor)
- Multi-organ failure
- Not expected to survive > 48 hours
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：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Treatment
Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC. |
Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC. |
|
プラセボコンパレーター：Control
Controls will receive two infusions of vehicle solution. |
Subjects in the control group will be treated with two IV infusions of vehicle solution. |
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 |
|---|---|---|
|
Proportion of Participants Alive and Free of Respiratory Failure
時間枠：60 days
|
The proportion of participants who are alive and free of respiratory failure following treatment with UC-MSC therapy. |
60 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1. All-Cause Mortality
時間枠：60 Days
|
Number of Participants Who Died (All-Cause Mortality) |
60 Days
|
|
2. Survival Status
時間枠：31 Days
|
Number of Participants Alive at Day 31 |
31 Days
|
|
3. Incidence of Serious Adverse Events (SAEs)
時間枠：31 Days
|
Number of Participants Experiencing Serious Adverse Events (SAEs) |
31 Days
|
|
4. Serious Adverse Event-Free Survival
時間枠：31 Days
|
Number of Participants Alive Without Serious Adverse Events |
31 Days
|
|
5. Time to Clinical Recovery
時間枠：Up to 60 Days
|
Time to Clinical Recovery (Days) |
Up to 60 Days
|
|
6. Time to Oxygen Requirement ≤ 40%
時間枠：Up to 60 Days
|
Time to Oxygen Requirement ≤ 40% (Days) |
Up to 60 Days
|
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 (推定)
一次修了 (推定)
研究の完了 (推定)
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。