Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Efficacy of HUNS001-01 administration
研究概览
简要总结
The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are:
Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention?
Participants will receive the below interventions.
- Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging)
- Harvest of platelet concentrates (PC)
- Harvest of bone marrows (BM)
- Receive intracerebral transplantation surgery of HUNS001-01
- Post-operative rehabilitation
- Follow-up studies (until 1 year or termination of the trial)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stem cell transplantation
Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10^7 MSC cells)
干预措施: Stem cell Transplantation (Drug)
结局指标
主要结局
Efficacy of HUNS001-01 administration
时间窗: one year
The frequency of the improvement in mRS of disability by 1 or more from baseline
次要结局
- Safety of HUNS001-01 administration(one year)
- Change in NIHSS examination(one year)
- Change in FIM examination(one year)
- Change in Fugl-Myer examination(one year)
- Change in Barthal index examination(one year)
- Change in FDG-PET examination(one year)
- Change in IMZ-SPECT examination(one year)