EUCTR2014-000307-26-ES进行中（未招募）1 期
Clinical trial Phase I/II, test of concept, double blind, randomized, controlled with placebo, to evalue the safety and efficiency of the treatment with expanded adult mesenchymal stem cells from allogenic adipose tissue, in patients with HIV infection with controlled viral load and immunological discordant response.
Iniciativa Andaluza en Terapias Avanzadas-Fundación Pública Andaluza Progreso y Salud0 个研究点目标入组 15 人开始时间: 2016年2月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.HIV- 1 infection
- •2.Both sex > 18 years old
- •3.In antirretrovial treatment
- •4.HIV viral load < 50 copies/ml during > 1 year
- •5.CD4+ value < 350/?l
- •6.Immunological discordant response (IDR) defined as:
- •- increase <75 or <150 CD4 + / µl after one or two years of undetectable viral load, respectively with the basal situation
- •- recount of CD4 + <350/?l after 3 years of anti-retroviral treatment and undetectable viral load (<50 copias/ml) ? 1 year.
- •7.Writen inform consent form from the patients.
- •8.Commitment to use a contraceptive method with proved efficiency in men and women during the duration of the clinical trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Pregnancy, lactation, or refusal to use contraceptive methods with proved efficiency in men and women.
- •2. Opportunists infections in treatment
- •3. Active coinfecctions for virus B and C of the hepatitis
- •4. Stages C of liver cirrosis, according to Child Plugh classification.
- •5. Portal hypertension and / or hypersplemism of any etiology
- •6. Presense of malignant neoplasm.
- •7. Treatment in the last twelve months with steroids, inmunomodulators, interferon, chemotherapy or any treatment that could reverberate in the number of CD4.
- •8. Any analytical alteration degree 3 or 4 (scale AIDS Clinical Trials Group), confirmed, in the previous blood test taken before the ASC's first infusion.
研究者
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