A Prospective, Randomized Controlled Study of Human Induced Pluripotent Stem Cell-derived Mesenchymal Stromal Cells (iMSC) for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Cumulative incidence of degree III-IV aGvHD
研究概览
简要总结
An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.
详细描述
This is an open-label, randomized, controlled study, enrolled subjects(patients at risk for aGVHD of degree III-IV after allogeneic hematopoietic stem cell transplantation) will be 1:1 randomized to experimental group or control group. Control group will receive conventional aGVHD prophylaxis and the experimental group will receive iMSC injection plus conventional aGVHD prophylaxis, with 28 cases in each group, for a total of 56 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;
- •No gender restrictions and age between 14-70 years old；
- •Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；
- •Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP< 0.14 at +7d, another test was performed at +14d)；
- •Estimated survival≥ 24 weeks；
- •Eastern Cooperative Oncology Group（ECOG）≤ 2 points and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)≤ 3 points；
- •Subjects were be treated within 5 days after enrollment；
- •Informed consent and willingness to participate in the study.
排除标准
- •Serious organ dysfunction such as organ failure after allogeneic HSCT;
- •Received more than once HSCT (including autologous transplants);
- •Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;
- •Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;
- •Primary malignant hematologic disease was not remission;
- •Within 6 months prior to enrollment, subjects had other diseases or their physiological conditions may interfere the study results, or had life-threatening complications;
- •Those who are suffering mental or neurological illnesses, unable to express will correctly;
- •Those with active malignant solid tumors within 5 years prior to participation in this study, with the exception of radically treated cervical cancer, in situ limited prostate cancer, and nonmelanoma skin cancer;
- •Subjects known to be potentially allergic or highly sensitized to the cell therapy in the study protocol;
- •Have participated or are participating in another clinical trial within one month prior to enrollment;
- •Those who are judged by the investigator to be unsuitable for participation in this clinical trial.
研究组 & 干预措施
Control group
conventional aGVHD prophylaxis
干预措施: conventional aGVHD prophylaxis (Combination Product)
Trial group
conventional aGVHD prophylaxis + iMSC
干预措施: iMSC (Biological)
Trial group
conventional aGVHD prophylaxis + iMSC
干预措施: conventional aGVHD prophylaxis (Combination Product)
结局指标
主要结局
Cumulative incidence of degree III-IV aGvHD
时间窗: Within 100 days of first dose
Cumulative incidence of degree III-IV aGvHD at 100 days Within 100 days of first dose
次要结局
- Disease-free survival (DFS)(Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose)
- Adverse Event(AE) or Serious Adverse Event(SAE)(Day 100 after initial infusion)
- Cumulative Recurrence Rate (CIR)(Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose)