DRKS00000763招募中1 期
Adjunct treatment of multidrug resistant (MDR) or extreme drug resistant (XDR) Tuberculosis (TB) with autologous mesenchymal stem cells. - MSC-1-TB
Republican Research and Practical Center for Pulmonology and Tuberculosis (RRPCPT), Minsk Belarus0 个研究点目标入组 40 人开始时间: 2011年11月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 70 Years（—）
- 性别
- All
入选标准
- •MDR or XDR without response to therapy, chronic disease or at least a single treatment failure
- •Patients for enrolment must satisfy all the criteria below:
- •2.Hepatitis -B and -C negative patient
- •3.MDR- or XDR- TB confirmed by drug susceptibility testing (DST) at the time of the bone marrow harvest for MSC generation
- •4.Patient who show clinical signs of worsening despite receiving second line TB treatment
- •5.M.tuberculosis (Mtb) detected by culture with available drug susceptibility results for current isolate
- •6.Age: at least 21 years
排除标准
- •Pregnancy, tumor disease, HIV+, Hepatitis C+, active Hepatitis B, Blood koagulation problems, active infections other than tuberculosis.
- •Any one of the criteria below make the patient ineligible for enrolment into the study
- •1.HIV positivity
- •2.Hepatitis B or C positivity
- •3.First line drug treatment susceptible Mtb strain
- •4.Autoimmune diseases
- •5.Pregnancy
- •6.Multi-organ failure
- •7.Sepsis (any bacterial sepsis)
- •8.Abscess formation other than Mtb
- •10.Anti-DNA antibodies
- •11.Allergies
- •12.Clinical significant hypertonus
- •13.Younger than 21 years and older than 65 years.
研究者
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