A Single-Arm Study to Assess the Safety of Transplantation With Human Placental-Derived Stem-Cells Combined With Unrelated and Related Cord Blood in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Safety
研究概览
简要总结
The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and HPDSC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 55 years of age
- •Life expectancy greater than 3 months
- •Lansky performance status ≥ 50% (children) or Karnofsky performance status ≥ 70% (adults) or ECOG performance status 0-2 (adults)
- •DLCO > 50 percent predicted
- •Left ventricular ejection fraction > 40% estimated
- •Creatinine clearance or estimated GFR . 60 mL/min/1.73m2
- •Serum bilirubin < 1.5x upper limit of normal
- •Transaminases < 3x upper limit of normal
- •Absence of uncontrolled infection
- •HIV negative
排除标准
- •Fanconi Anemia
- •Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Uncontrolled infection
- •Pregnant or breast-feeding females
- •Received other investigational agents within 30 days prior to the start of the conditioning regimen
研究组 & 干预措施
Group A
related cord blood with ≥3/6 HLA match to the patient and related HPDSC
干预措施: Human Placental Derived Stem Cell (Drug)
Group B
unrelated cord blood with ≥ 4/6 HLA match to the patient and unrelated HPDSC
干预措施: Human Placental Derived Stem Cell (Drug)
Group C
unrelated cord blood with ≥4/6 HLA match to the patient but related to HPDSC
干预措施: Human Placental Derived Stem Cell (Drug)
Group D
double unrelated cord blood units with ≥4/6 HLA match to patient and each other and unrelated HPDSC
干预措施: Human Placental Derived Stem Cell (Drug)
结局指标
主要结局
Safety
时间窗: 100 days
to evaluate the safety of human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells in patients with malignant and non-malignant diseases.
次要结局
- donor chimerism(1 year)
- engraftment(1 year)
- Survival(100 days and 180 days)
- Relapse(100 days and 180 days)
- Mortality(1 year)