Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.
详细描述
The overall clinical development strategy of this project is to conduct this Phase I dose escalation study entitled "A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients with Recent Intracerebral Hemorrhage". This study will be performed under this current IND application and will be limited to the proposed 12 subjects (3 IV and 1 IT dose groups).
In this application the investigators are proposing to evaluate safety and feasibility of allogeneic, bone marrow (BM) derived mesenchymal stem cells (MSC) to induce neuroregeneration, improve neurological function and alleviate inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18 years or older
- •Gender: Male or female
- •Acute spontaneous supratentorial ICH documented by head CT with ICH Score between 2 - 4 inclusive
- •Stable ICH hematoma volume 60mL or less as measured by ABC2 method by 24-72hrs
- •Ability to be enrolled within 72 hours of onset of stroke symptoms
- •Ability to provide written personal or surrogate consent. Only subjects who have signed the ICF will be enrolled into the study. The ICF will include elements required by Mayo IRB and FDA in US 21CFR
- •Subject must have adequate renal function; creatinine <1.5g/dl.
- •Subject must be available for all specified assessments at the study site through the completion of the study.
- •Subject must provide written ICF and authorization for use of and disclosure of PHI.
排除标准
- 未提供
研究组 & 干预措施
Group 3 MSC dose 2 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants.
干预措施: MSC (Biological)
Group 4 MSC dose 0.5 x 10^6/kg I
Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants.
干预措施: MSC (Biological)
Group 1 MSC dose .5 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants.
干预措施: MSC (Biological)
Group 2 MSC dose 1 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants.
干预措施: MSC (Biological)
结局指标
主要结局
Occurrence of adverse events
时间窗: 1 year
Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.
次要结局
- Changes in neurological function test(Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180)
研究者
Abba C. Zubair, M.D., Ph.D.
medical Director
Mayo Clinic