Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Our hypothesis is that ex vivo activated immune cells would produce multiple known and unknown potent hematopoietic cytokines, working in concert, these cytokines help stem cell growth and differentiation. Additionally, these cells travel and home to bone marrow as well as spleen and liver involved in hematopoietic activities, where direct cell-cell contact may be beneficial.
详细描述
Patients will be required to stay in our hospitals to receive the immunotherapy. Allogeneic peripheral blood mononuclear cells from healthy donors and the autologous peripheral mononuclear cells will alternately used for the treatment. Patients are expected to spend at least 6 to 12 months in the hospital and won't be released until they have improved significantly.
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
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Idiopathic Aplastic Anemia
- •Not Eligible for Bone Marrow Transplantation
- •Not Responsive to Conventional Immunosuppressive Therapy
排除标准
- •Leukemia or MDS or PNH or Fanconi's Disease
- •pregnancy
- •Allergic to Blood Product
- •Severe Hypertension or Heart Disease
- •Liver or Kidney Disease
研究组 & 干预措施
Hemathera
Patients will receive cell-based immunotherapy.
干预措施: Ex vivo immunotherapy (Drug)
结局指标
主要结局
Survival
时间窗: 2 years
次要结局
- Hematological Parameters(2 years)
- Hematopoietic Activities in Bone Marrow(2 years)
- Quality of Life(2 years)