NCT02051673No Longer Available不适用
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)
详细描述
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
- •Patient is receiving first renal transplant
- •Patient is receiving a renal transplant only
- •The crossmatch is negative between donor and recipient
- •Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) and agree to use reliable contraception for 1 year following transplant
- •Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF)
- •No evidence of donor-specific antibody presently or historically
排除标准
- •Clinically active bacterial, fungal, viral or parasitic infection
- •Pregnancy
- •Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant
- •Previous radiation therapy at a dose which would preclude TBI
- •Positive crossmatch between donor and recipient
- •Evidence for immunologic memory against donor
- •BMI >35 or <18
- •Re-transplant
- •Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV
研究者
研究点 (1)
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