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治験 NCT07409259（対象：Acute-on-Chronic Liver Failure (ACLF)）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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PT-MSCs Exosome Injection in the Treatment of Chronic-to-acute Liver Failure 早期第I相・早期フェーズ1 20 無作為化
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07409259 は Acute-on-Chronic Liver Failure (ACLF) に関する 治療 の研究で、早期第I相・早期フェーズ1 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2026年1月1日 から開始しています。20 名の参加者 の募集が計画されています。この試験は Third Affiliated Hospital, Sun Yat-Sen University によって主導され、2027年8月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月13日 です。
概要
The goal of this single-center, prospective, randomized controlled study is to evaluate the safety and efficacy of PT-MSCs Exosome Injection (code: PT-MSCs-EVS-2023-1) in treating patients with acute-on-chronic liver failure (ACLF). As an exploratory study with a small sample size, the primary focus is to observe safety outcomes and preliminary efficacy. The study will enroll patients aged 18 to 65 years who meet the...もっと見る
公式タイトル
Single-center, Prospective, Randomized Controlled Study of PT-MSCs Exosome Injection (Code: PT-MSCs-EVS-2023-1) in the Treatment of Chronic-to-acute Liver Failure
疾患名
Acute-on-Chronic Liver Failure (ACLF)その他の研究識別子
- PL21
NCT番号
開始日
2026-01-01
最終更新日
2026-02-13
終了予定日
2027-08-31
目標参加者数
20
試験の種類
介入研究
治験の相・段階
早期第I相・早期フェーズ1
状況
実施中／登録終了
キーワード
Acute -On-Chronic Liver Failure
Bio-artificial liver
Exosome
Mesenchymal stem cells
Bio-artificial liver
Exosome
Mesenchymal stem cells
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Control Group Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. Artificial liver support or liver transplantation may be performed based on the investigator's clinical judgment. | standard comprehensive internal medical treatment, Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. |
実験的Study Group In addition to the standard treatment received by the control group, participants will receive PT-MSCs Exosomes (2×10\^11 particles per dose). | exosome injection For the Study Group, the exosome injection is diluted in 100 mL of normal saline and administered via intravenous infusion over a period of not less than 2 hours. Treatment is administered once every 3 days (on Day 1, Day 4, Day 7, and Day 10) for a total of 4 doses. standard comprehensive internal medical treatment, Participants will receive standard comprehensive internal medical treatment, including antiviral therapy, hepatoprotective drugs, and symptomatic support. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
12-Week Survival Rate | The percentage of participants who are alive at 12 weeks after enrollment. | 12 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Changes from the baseline in COSSH-ACLF II score | The Chinese Severe Hepatitis B Study Group (COSSH), based on a multicenter, open-label large cohort study, has established a novel prognostic scoring system for hepatitis B virus (HBV)-ACLF: COSSH-ACLF II s. The COSSH-ACLF II score is calculated as: 1.649×ln(INR) + 0.457×HE grade + 0.425×ln(neutrophils) + 0.396×ln(TBil) + 0.576×ln(urea) + 0.033×age. Theoretically, the score ranges from \~1.0 to \~15.0, though clinically observed values typically fall between 4.5 and 10.0. A score of less than 7.4 indicates a low-risk group, a score between 7.4 and 8.4 indicates a moderate-risk group, and a score greater than 8.4 indicates a high risk of 28- and 90-day mortality.Higher scores indicate greater severity of liver failure and a worse outcome. | 12 weeks |
Changes from the baseline in Child-Pugh score | The Child-Pugh Score assesses the prognosis of chronic liver disease based on five indicators: hepatic encephalopathy, ascites, total bilirubin, albumin, and PT/INR. The total score ranges from 5 to 15. Higher scores indicate worse liver function. (Classification: Grade A = 5-6 points; Grade B = 7-9 points; Grade C = 10-15 points.) | 12-weeks |
Change from Baseline in Clinical Symptom Score | Assessment of clinical symptoms including fatigue, anorexia, nausea, jaundice, and level of consciousness. Each symptom is graded on a scale from 0 (absent) to 3(severe). The individual scores are summed to calculate a total symptom score ranging from 0 to 15. Higher scores indicate more severe symptoms. | 12 weeks |
4-Week Survival Rate | The percentage of participants who are alive at 4 weeks after enrollment | 4 weeks |
The rate of participants with adverse outcomes at Week 4 and Week 12 | The rate of adverse outcomes, defined as death, treatment abandonment, or liver transplantation. | 4-week , 12-week |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Aged 18 to 65 years, regardless of gender.
- Diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to the diagnostic criteria in the "Guidelines for Diagnosis and Treatment of Liver Failure (2024 Edition)."
- COSSH-ACLF II score < 7.4.
- Participants must be fully informed about the study and voluntarily sign a written informed consent form prior to participation.
- Patients with chronic liver failure.
- Patients with active bleeding or Disseminated Intravascular Coagulation (DIC) that has not been effectively controlled.
- Known allergy to blood products or any medications/drugs used in the treatment protocol.
- Patients with circulatory failure.
- History of myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months.
- History of malignancy within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Pregnant or lactating women.
- Any other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in the trial.
Third Affiliated Hospital, Sun Yat-Sen University責任者
Liang Peng, 主任研究者, Professor, Third Affiliated Hospital, Sun Yat-Sen University
連絡先情報がありません。
1 1カ国の場所
Guangdong
Third Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China 510630, Guangzhou, Guangdong, 510630, China