Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Adverse events
研究概览
简要总结
Hypothesis: Intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple sclerosis.
Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis.
详细描述
Disease under investigation: Multiple Sclerosis
Phase: I/IIA
Number of patients: 10
Design: 18 month cross over, single treatment at 6 months
Intervention: Administration of bone marrow-derived autologous mesenchymal stem cells
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Clinically definite multiple sclerosis
- •Expanded Kurtzke Disability Status Score 2.0 - 6.5 (inclusive)
- •Evidence of optic nerve damage by:
- •history of optic neuritis, or
- •relative afferent pupillary defect, or
- •optic atrophy on fundoscopy, or
- •abnormal visual evoked potential from either or both eyes suggestive of demyelination
- •Prolonged visual evoked potential P100 latency with preserved waveform
- •T2 lesion on MRI optic nerve
- •Retinal nerve fibre layer thickness on optical coherence tomography > 40 microns
排除标准
- •Age < 18 years
- •Age > 65 years
- •Patient lacks capacity to give informed consent
- •Presence of a severe bleeding disorder
- •Planning a pregnancy during the trial period
- •Current MS disease modifying therapy
结局指标
主要结局
Adverse events
时间窗: 0,1,2,3,4,12 and 52 weeks post treatment
次要结局
- Visual function (acuity and colour)(12 and 52 weeks post treatment)
- Visual evoked potential latency(12 and 52 weeks post treatment)
- Optic nerve Magnetisation Transfer Ratio(12 and 52 weeks post treatment)
- Retinal nerve fibre layer thickness (by optical coherence tomography)(12 and 52 weeks post treatment)
- Brain lesion Magnetisation Transfer Ratio(12 and 52 weeks post treatment)
- MRI brain T1 hypointensity load(12 and 52 weeks post treatment)
- Multiple Sclerosis Functional Composite Score(12 and 52 weeks post treatment)
- Expanded Kurtzke Disability Status Score(12 and 52 weeks post treatment)
研究者
Peter Connick
Research Associate
University of Cambridge