NCT05794425招募中1 期
A Multicenter Collaborative Clinical Study of Umbilical Cord Blood Combined With Umbilical Cord Derived Mesenchymal Stem Cells in the Treatment of Bone Marrow Failure Disorders
Shandong Qilu Stem Cells Engineering Co., Ltd.8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The multicenter collaborative clinical study conducted a systematic clinical observation in the treatment of bone marrow failure diseases via UCB&UC-MSCs , in order to observe its clinical efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bone marrow failure disorders, including aplastic anemia, pure red cell aplastic anemia, immune-related pancytopenia, paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, acute arrest of hemopoiesis, and cytopenia of unknown significance;
- •Patients with no severe impairment of liver and kidney function (total bilirubin (TBIL): ≤ 1.5×ULN; ALT or AST: ≤ 2.5×ULN; Alkaline phosphatase: ≤ 3×ULN; Serum creatinine: ≤ 1.5×ULN);
- •The prothrombin time (PT) or activated partial thrombin time (APTT) or international normalized ratio (INR): ≤ 1.5×ULN in the absence of anticoagulant therapy;
- •The left ventricular ejection fraction (LVEF): ≥50% by cardiac echocardiography
- •Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) were negative. If any of the above items is positive, the HBV DNA titer in peripheral blood must be lower than the detection limit or 1×10^3 copys/ml;
- •Patients with no plans for stem cell transplantation;
- •Patients with ECOG 0-2;
- •Those who voluntarily participate in this clinical study and have signed an informed consent .
排除标准
- •Patients who have suffered malignant tumors other than squamous cell carcinoma of the skin, basal cell carcinoma of the skin, malignant melanoma cured by surgery, and carcinoma in situ of the cervix in the past 5 years;
- •Patient with severe cardiac insufficiency (e.g. grade Ⅲ、Ⅳ by NYHA classification NYHA), and medically uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥110 mmHg);
- •Patients with severe mental illness;
- •Patients with clinically significant infection should be recruited with delay;
- •AST or ALT: above 3 times the upper limit of normal, creatinine, total bilirubin, or alkaline: phosphatase (ALP): above 1.5 times the upper limit of normal;
- •Patients with test positive for HIV, HCV or syphilis;
- •Patients with severe allergies or allergic to the active ingredients, excipients of the drug, or blood products in this clinical trials;
- •Patients who are pregnant or breastfeeding, or have a childbirth plan in the near future;
- •Patients receive allogeneic/autologous hematopoietic stem cell transplantation by the assessment of investigators;
- •There are other conditions that the investigators consider inappropriate for inclusion.
研究组 & 干预措施
Cyclosporine A
Experimental
干预措施: Cyclosporine A (Drug)
UCB+UC-MSCs
Experimental
干预措施: Umbilical cord blood & Umbilical cord derived mesenchymal stem cells (Biological)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to two years
To evaluate efficacy of UCB in combination with UC-MSCs in the treatment of bone marrow failure disorders
次要结局
- Progression-free Survival (PFS)(Up to two years)
- Overall Survival (OS)(Up to two years)
研究者
研究点 (8)
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