ヒトにおける新生児胸腺移植 (SUPERTHYM)
新生児胸腺移植のための人類初の超顕微手術技術
この臨床試験の目的は、成人患者における新生児胸腺移植の安全性を実証することです。 回答を目指す主な質問は次のとおりです。
- 新生児の胸腺移植は安全な方法ですか?
- 新生児胸腺移植の有害事象プロファイルは?
これは単一科目の研究です。したがって、比較グループはありません。 参加者は、手術前、手術中、手術後に集学的な支持療法を受けます。
調査の概要
詳細な説明
不適切な胸腺形成は、おそらく自己免疫、免疫不全、および免疫老化に関連しています。 胸腺形成の増強は、そのような免疫学的現象の管理または研究にとって魅力的かもしれません。 胸腺形成は、さまざまな動物モデルで示されているように、成人の胸腺移植によってサポートされています。 ヒトの胸腺新生を促進するためのいくつかのアプローチが報告されており、その中には、胸腺の in vitro および in vivo 再生、同種処理胸腺組織の無血管移植などが含まれます。
新生児の胸腺移植のための超顕微手術技術は、最近ウサギで説明されましたが、ヒトで説明されたことはありません。 この手法は、人間の新生児胸腺移植を実行するために使用できます。 この技術が安全であることが証明されれば、胸腺形成に対するその効果とさまざまな健康状態に対するその有効性を調査するために、将来の研究が続きます.
この単一被験者による初のヒト臨床試験は、骨髄移植や強力な化学療法の候補ではない急性骨髄性白血病の成人における新生児胸腺移植の安全性を実証し、有害作用プロファイルを調査することを目的としています。 このヒトモデルは、新生児胸腺移植の安全性を研究することを可能にするだけでなく、胸腺形成に対する手順の影響を調査することも可能にします.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Luis F Tintinago-Londoño, MD
- 電話番号:7433 +573319090
- メール:luis.tintinago@fvl.org.co
研究場所
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Valle Del Cauca
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Cali、Valle Del Cauca、コロンビア、760031
- 募集
- Fundación Valle del Lili
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コンタクト:
- Luis F Tintinago-Londoño, MD
- 電話番号:7433 +573319090
- メール:luis.tintinago@fvl.org.co
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主任研究者:
- Luis F Tintinago-Londoño, MD
-
副調査官:
- Francisco J Jaramillo-Echeverry, MD PhD-c
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副調査官:
- Sergio I Prada-Ríos, MSc MPA PhD
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副調査官:
- William Victoria-Morales, MD
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副調査官:
- Juan F Vélez-Moreno, MD
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副調査官:
- Juan C Arias-Millán, MD
-
副調査官:
- Hugo D Campos-Martínez, MD
-
副調査官:
- Alejandro Sandoval-Daza, MD
-
副調査官:
- Nhora M Silva-Pérez, MD
-
副調査官:
- Juan C Bravo-Ocaña, MD
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副調査官:
- Daniel F Isaza-Pierotti, MD MCSO
-
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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
包含基準:
- 緩和ケアにおける骨髄性(AML)またはリンパ性(ALL)の急性白血病の診断。
- 骨髄移植の候補ではありません。
- 集中化学療法の候補ではありません。
除外基準:
- 骨髄移植の過去の病歴。
- -重度の認知機能低下または認知症の過去の病歴。
- -重度の肝不全の過去の病歴。
- -慢性腎臓病(CKD)ステージ4〜5の過去の病歴。
- -過去90日以内の急性冠症候群の過去の病歴。
- -過去90日以内の急性虚血性脳卒中の過去の病歴。
- -過去90日以内の非代償性うっ血性心不全(CHF)の過去の病歴。
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:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
実験的:新生児胸腺移植
被験者の橈骨前腕への新生児胸腺移植のための超顕微手術技術。
ドナーは、定期的な胸腺部分切除術を必要とする胸骨切開による心臓矯正手術を受ける新生児になります。
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ドナーの新生児胸腺血管は、通常の胸腺部分切除術の直後に解剖されます。
これらの血管は、超顕微手術技術を使用して、橈骨前腕内のレシピエントの貫通血管に吻合されます。
移植片は、処置後14〜21日目に外植されます。
他の名前:
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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 |
---|---|---|
有害事象(AE)の発生率
時間枠:14-21日
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有害事象の発生率、およびバイタル サイン値、症状、身体検査所見、臨床検査および画像安全性データの臨床的に関連する変化の発生率。
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14-21日
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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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胸腺移植機能
時間枠:14-21日
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ナイーブ (CD45+ CD3+ CDRA+) およびメモリー (CD45+ CD3+ CDRA-) T リンパ球のパーセンテージ (%) の変化 (生着前 (-1 日目)、および外植前 (+14-21 日目) のフローサイトメトリーによる T リンパ球の総数に対する変化) )、胸腺形成のバイオマーカーとして。
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14-21日
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組織生存率
時間枠:14-21日
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手術後14-21日目に外植された胸腺組織におけるエオシン-ヘマトキシリンおよび免疫化学染色を用いた光学顕微鏡検査による移植片拒絶の存在および程度(もしあれば)。
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14-21日
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ドナー受容体の互換性
時間枠:14-21日
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ヒト白血球抗原 (HLA) タイピング。
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14-21日
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協力者と研究者
捜査官
- 主任研究者:Luis F Tintinago-Londoño, MD、Fundacion Clinica Valle del Lili
出版物と役立つリンク
一般刊行物
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新生児胸腺移植の臨床試験
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NICHD Neonatal Research Network完了気管支肺異形成 | 幼児、在胎週数の割に小さい | 幼児、未熟児 | 幼児、低出生体重児 | 幼児、新生児アメリカ