MSC for Treatment of cGVHD After Allo-HSCT
Mesenchymal Stem Cell for Treatment of Chronic Graft-versus-host Disease After Allogenetic Hematopoietic Stem Cell Transplantation
調査の概要
詳細な説明
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cGVHD) remains an important complication that occurs in about 50% patients. The mortality of cGVHD and its complication could reach up to 50%,and cGVHD seriously influence the quality of life. At present, the first line treatment of cGVHD remains in discussion.
Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of cGVHD remains undetermined.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510515
- 募集
- Department of Hematology,Nanfang Hospital, Southern Medical University
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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:
- A patient age of 18-65 years
- Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Primary disease relapse
- Expected lifetime less than 3 months
- Patients with any conditions not suitable for the trial (investigators' decision)
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：並列代入
- マスキング：なし（オープンラベル）
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：MSCs group
MSCs group refers to treatment with mesenchymal stem cells (1×10^6 cells/kg, intravenously) weekly for 8 doses.
Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently.
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Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 mins) weekly.
MSCs will be administrated for 8 doses.
Glucocorticoids (i.e.
Methylprednisolone) will be used with an initial dose of 1mg/kg.
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA.
The targeted concentration is 200-300 ng/Ml.
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アクティブコンパレータ：Control group
Glucocorticoids and CsA will be used for treatment.
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Glucocorticoids (i.e.
Methylprednisolone) will be used with an initial dose of 1mg/kg.
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA.
The targeted concentration is 200-300 ng/Ml.
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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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ORR
時間枠：12 weeks after the first dose of MSCs
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Overall response rate （ORR）includes complete response (CR) and part response (PR).
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12 weeks after the first dose of MSCs
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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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OS
時間枠：1 year after the first dose of MSCs
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Overall survival (OS)
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1 year after the first dose of MSCs
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DFS
時間枠：1 year after the first dose of MSCs
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Disease-free survival (DFS)
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1 year after the first dose of MSCs
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Response rate
時間枠：4 weeks after the first dose of MSCs
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4 weeks after the first dose of MSCs
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EBV DNA-emia
時間枠：1 year after the first dose of MSCs
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EBV DNA-emia refers to detection of EBV DNA in peripheral blood via PCR.
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1 year after the first dose of MSCs
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CMV DNA-emia
時間枠：1 year after the first dose of MSCs
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CMV DNA-emia refers to detection of CMV DNA in peripheral blood via PCR.
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1 year after the first dose of MSCs
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PGF
時間枠：1 year after the first dose of MSCs
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Poor graft function (PGF) refers to a slow or incomplete recovery of blood cell counts (ANC ≤0.5x10^9/L and PLT ≤20x10^9/L) by +28 days after allo-HSCT or a fall in blood cell counts to levels fulfilling the diagnostic criteria for PGF after successful and prompt hematopoietic engraftment.
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1 year after the first dose of MSCs
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協力者と研究者
協力者
捜査官
- 主任研究者：Qi-fa Liu, MD、Nanfang Hospital of Southern Medical University
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
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