2024-518394-34-00招募中1 期
Regenerative Stem Cell Therapy for Stroke in Europe 1
Centre Hospitalier Universitaire Grenoble Alpes6 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年11月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 6
- 主要终点
- Phase Ib (Dose-effect study)
研究概览
简要总结
Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and in the phase 1b (RESSTORE 1b, Dose-effect study).
- •Male or female > 18-year-old
- •Hemispheric ischemic stroke (> 1.5 cm on 2 imaging slices) (i.e. non "lacunar" stroke) Admitted to the stroke unit within the first 24h after stroke onset
- •Patient must be included within 1st and 2nd day after stroke onset (signature of informed consent and randomization) (i.e. between 24 hours and 48 hours from stroke onset) and must be able to receive investigation treatment within the first week.
- •NIHSS > or equal to 7 including motor score (upper, lower limbs and hand) > or equal to 3
- •No decompressive craniectomy procedure planned or performed
- •Patient able to follow a rehabilitation program
- •Modified Rankin scale = 0 before stroke onset
- •Obtained signed informed consent from patient or legally acceptable representative
- •Negative pregnancy test for women of child-bearing age.
- •Non Inclusion Criteria:
- •Non-inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and the phase 1b (RESSTORE 1b, Dose-effect study).
- •Contraindication for MRI
- •Coma (score of 2 or more on item 1a of the NIHSS related to awareness)
- •Evidence on neuroimaging (CT or MRI) of a brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, or subarachnoid haemorrhage, or intracerebral parenchymal hematoma (petechial small haemorrhages are NOT a non-inclusion criteria)
- •Severe leucoariosis
- •Previous stroke
- •Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV (a controlled infection is NOT a non-inclusion criteria)
- •Active inflammatory and/or auto-immune diseases (such as Crohn disease, lupus, rheumatoid polyarthritis, renal or liver immune pathology)
- •History of cancer
- •Pre-existing dementia
- •A health status, any clinical condition (eg, short life expectancy, and coexisting disease) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial
- •Surgical or endovascular procedure planned in the following 3 months
- •Pregnancy / Breast feeding (women of childbearing age should have a negative pregnancy test prior to inclusion)
- •Patients who are participating in another therapeutic trial or who have previously participated in a biotherapy trial
- •Non-membership to a social security scheme
- •Inability or unwillingness of the individual or their legal guardian/representa tive to provide written informed consent, according to national regulations.
排除标准
- 未提供
研究组 & 干预措施
Adipose derived Stem Cells - 1.10^6cells/kg
Experimental
ADSC, single, IV, 1.10^6cells/kg
干预措施: Adipose derived Stem Cell (Drug)
Adipose derived Stem Cells - 2.10^6cells/kg
Experimental
ADSC, single, IV, 2.10^6cells/kg
干预措施: Adipose derived Stem Cell (Drug)
Adipose derived Stem Cells - 2,5.10^6cells/kg
Experimental
ADSC, single, IV, 2,5.10^6cells/kg
干预措施: Adipose derived Stem Cell (Drug)
Adipose derived Stem Cells - 3.10^6cells/kg
Experimental
ADSC, single, IV, 3.10^6cells/kg
干预措施: Adipose derived Stem Cell (Drug)
placebo
Placebo Comparator
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Phase Ib (Dose-effect study)
时间窗: 6 months after stroke onset
modelling the dose-effect
Phase Ia (Toxicity study)
时间窗: 7 days after stroke onset
cell-related serious adverse event
次要结局
- fMRI recovery(at 6 months post-stroke)
- Functionnal recovery(through study completion (2 years))
- Post stroke handicap(through study completion (2 years))
- Motor recovery(over 6 months post-stroke)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability(through study completion (2 years))
- Blood biomarkers for stroke recovery(at 6 months post-stroke)
研究者
Pr Olivier DETANTE
Scientific
Centre Hospitalier Universitaire Grenoble Alpes
研究点 (6)
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