NL-OMON55910尚未招募2 期
Assess effect and safety of intra-arterial autologous mesoangioblasts administration to the upper arm of m.3243A>G mutation carriers - Effect and safety MABs administration m.3243A>G carriers
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Written informed consent - Age: 18-64 year - Sex: male/female - Patients with
- •the m.3243A>G mutation load of 50%-90% determined in skeletal muscle or derived
- •from age-corrected calculation of blood m.3243A>G mutation load
排除标准
- •- Use of dabigatran, apixaban, edoxaban or rivaroxaban (DOACs) as
- •anti-coagulants
- •- Have a weekly alcohol intake of >= 35 units (men) or >= 24 units (women)
- •- Current history of drug abuse
- •- Deficient immune system or autoimmune disease
- •- Significant concurrent illness
- •- Ongoing participation in other clinical trials with intervention
- •- Pregnant or lactating women
- •- Psychiatric or other disorders likely to impact on informed consent
- •- Patients unable and/or unwilling to comply with treatment and study
- •instructions
- •- A history of strokes with signs of extra-pyramidal or pyramidal syndrome
- •- Allergy for contrast fluid
- •- Peripheral signs of ischemia or vasculopathy
- •- Claustrophobia
- •- Metal implants
- •- Any other factor that in the opinion of the investigator excludes the patient
- •from the study
研究者
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