Effectiveness and Safety of Intravenous Infusion of Bone Marrow Derived Allogeneic Multipotent Mesenchymal Stromal Cells for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis in Hematological Patients With Aplasia After High-dose Chemotherapy.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
研究概览
简要总结
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion. This is a single arm study with no control. All patients receive cell therapy.
详细描述
Patients with verified diagnosis Hodgkin's lymphoma or non-Hodgkin's lymphoma will undergo peripheral blood stem cell mobilisation and collection (chemotherapy + G-CSF or G-CSF+Plerixafor).
After that high-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme).
Patient will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells infusion 48 hours after last administration of cytotoxic agent . Number of cells calculated according to patient's body weight (1,5-2,0 mln of cells/kg), time of infusion - 30 minutes. Two hours later patient will receive autologous peripheral blood cells infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffers from Hodgkin's lymphoma, non-Hodgkin's lymphoma with complete or partial remission.
- •Patient is candidate to high-dose chemotherapy with subsequent autologous hematopoietic stem cell transplantation.
- •Absence of infection, cardiovascular, respiratory, renal and hepatic dysfunctions, focal neurological symptoms.
- •Karnofsky score at least
- •Patient successfully undergone mobilization of peripheral blood stem cells.
- •Patient is familiar with Participant information sheet.
- •Patient signed informed consent form.
- •Non-inclusion Criteria:
- •Severe chronic comorbidity with symptoms of organ or system failure.
- •Significant abnormalities in laboratory tests.
- •Participation in other clinical trials (or intake of study drugs) within prior 3 months.
- •Conditions restricting commitment to participating in the trial (dementia, neuropsychiatric disorders, drug and alcohol abuse)
- •Patients with malignant solid tumors.
- •Patients with medical history of heterotopic ossification.
排除标准
- •Progression or relapse of lymphoma during therapy.
- •Confirmed syphilis, HIV, hepatitis B or C infection
- •Absence of clinical and laboratory signs of hematopoietic recovery and persistent enterocolitis at day 14 after the manipulation (Visit 15). While the patient remains in the hospital and continues treatment according to requirements of standard therapy
研究组 & 干预措施
allogeneic MMSCs infusion
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion.
干预措施: Peripheral blood stem cell mobilisation and collection (Procedure)
allogeneic MMSCs infusion
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion.
干预措施: High-dose chemotherapy (Drug)
allogeneic MMSCs infusion
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion.
干预措施: Bone marrow derived allogeneic MMSCs infusion (Drug)
allogeneic MMSCs infusion
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion.
干预措施: Autologous peripheral blood stem cells infusion (Procedure)
结局指标
主要结局
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
时间窗: 2 weeks after treatment
次要结局
- Time of hematopoietic recovery(Follow up to completion (up to 3 months after treatment))
- Transfusion needs(Follow up to completion (up to 3 weeks after treatment))
- Neutropenic enterocolitis(Follow up to completion (up to 3 months after treatment))
- Infectious complications(Follow up to completion (up to 3 months after treatment))
研究者
Zarui Simavonyan
MD
Burnasyan Federal Medical Biophysical Center