Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change the functional properties of cells will be evaluated by T-SPOT TB®.
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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.
研究组 & 干预措施
receivers
- Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, 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.
干预措施: blood (Biological)
Donors
- Member of the siblings and HLA-matched 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
干预措施: blood (Biological)
结局指标
主要结局
Change the functional properties of cells will be evaluated by T-SPOT TB®.
时间窗: 1 day, 5 day ,8 day
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.
Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
时间窗: 1 day, 5 day ,8 day
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.
次要结局
- Response to anti-infectious immunity(24 months)
- Response to anti-tumor immunity(24 months)