Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
详细描述
This is an expanded access single-dose study with the primary goal of treatment submitted at the request of an individual patient with complete C5-6 spinal cord injury (SCI) resulting in quadriplegia who does not qualify for any current clinical trials and for whom there are no other FDA approved fully restorative treatments. The overall objective of this study is to evaluate patient's response, adverse events and serious adverse events (AE/SAEs), and cell expansion characteristics of a single intravenous (IV) infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in a subject with complete SCI resulting in quadriplegia.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Cognitively intact, capable of giving informed consent
- •Clinical diagnosis of a non-penetrating traumatic SCI
- •Asia Impairment Scale grade of A, B, or C
排除标准
- •Prior history of:
- •Brain injury
- •Recent or ongoing infection
- •Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease,
- •Neurodegenerative disorders
- •Immunosuppression as defined by WBC<3,000 cells/ml at baseline screening,
- •Chemical or ETOH dependency
- •Having a contraindication to MRI scans
- •Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration
- •Participation in other interventional research studies
- •Unwillingness to return for follow-up visits