Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft (CCR7-CD4-DPL)
Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.
調査の概要
詳細な説明
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This first step will confirm the results previously obtained in a situation incompatible HLA .
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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LIlle、フランス、59037
- Diseases of Blood Service HURIEZ hospital CHRU de LILLE
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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:
Inclusion criteria of the receiver anti -infectious immunity
- Man or woman aged 18-65 years
- Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
- In a complete remission rate of leucocytes with ≥ 2G / L
- Affiliated to social security person or beneficiary of such a scheme.
- Having signed informed consent
Inclusion criteria for the study of the receiver of anti tumor immunity
- Man or woman aged 18-65 years
- Achieved a hyperleucocytic acute myelogenous leukemia ( leukocytes ≥ 20G / L)
- Patients whose blasts at diagnosis were cryopreserved in the tumor bank of the University Hospital of Lille (Professor Claude Prudhomme )
- Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
- In a complete remission rate of leucocytes with ≥ 2G / L
- Affiliated to social security person or beneficiary of such a scheme.
- Having signed informed consent receivers
Inclusion criteria of the donor
- Man or woman aged 18-65 years
- Member of the HLA-matched siblings and A, B, Cw, DR, DQ
- Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)
- Having a rate of circulating lymphocytes ≥ 1 G / L
- Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population
- The statutes CMV and EBV are known (positive or negative).
- Affiliated to social security person or beneficiary of such a scheme. who signed informed consent -
Exclusion Criteria:
Criteria for non inclusion of the pairs donor / Receiver
- Private person of liberty by judicial or administrative decision
- Person subject to a measure of legal protection
- Pregnant or breastfeeding woman
- People do not understand French or understanding with a disability.
- Major Protected Person in emergency and refusing or unable to give informed consent At any time, individuals may request to be removed from the study Each subject may come out of the study by decision of the competent administrative authority of the promoter and the coordinating investigator but also by decision of a co-investigator or by decision of the interested himself in accordance with regulations and as mentioned in the form of obtaining consent.
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:診断
- 割り当て:非ランダム化
- 介入モデル:階乗代入
- 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:receivers
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assessment pre-donation of hematopoietic stem cells (blood sample)
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実験的:Donors
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assessment pre-donation of hematopoietic stem cells (blood sample)
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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 the lymphocyte proliferation will be evaluated using a scintillation spectrometer
時間枠:1 day, 5 day ,8 day
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Decrease in alloreactivity of TCD4.(composite)
Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
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1 day, 5 day ,8 day
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Change the functional properties of cells will be evaluated by T-SPOT TB®.
時間枠:1 day, 5 day ,8 day
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Decrease in alloreactivity of TCD4.(composite)
Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
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1 day, 5 day ,8 day
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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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Response to anti-infectious immunity
時間枠:24 months
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Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
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24 months
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Response to anti-tumor immunity
時間枠:24 months
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Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
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24 months
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協力者と研究者
捜査官
- スタディディレクター:YAKOUB-AGHA IBRAHIM, Professor、Chru de Lille
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2010_09
- 2010-A01231-38 (その他の識別子:ID-RDB number, ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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