Intraoperative Adipose-Derived Stem Cells Administration During the Secondary Release (Neurolysis) of a Reconstructed Nerve
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 主要终点
- Electrophysiological improvement
研究概览
简要总结
The goal of the investigator's observational, nonrandomized, open label study is to investigate the safety and efficacy of autologous adipose derived mesenchymal cells (ADSC) transplantation into the individuals with faiure in reconstruction of peripheral nerves. ADSC will be used during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. All enrolled patients will have a documented at least 2-years clinical and electrophisiological observation. Each patient will recive once 10 microinjections of ADSC along the injured nerve, directly after nerve neurolysis. Safety, adverse events and efficacy will be confirmed by clinical, elecrophisiological (EMG, Sensory Thyreshold) and DASH survey.
详细描述
The aim of the study will be an evaluation of undifferentiated Adipose-Derived Stromal/Stem Cells (ADSC) usage during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. Patients who experienced failure of nerve reconstruction will be included in the study. During the revisional surgery, nerve fascicles will be released, and ADSCs will be isolated from harvested fat with enzymatic method in a standarized conditions. Cells will be administered through microinjections along the fascicles and around the adjacent tissues after external neurolysis. The follow-up will be continued at least 36 months.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically definite failure nerve reconstructed patients
- •lack of improvement after previous treatment
- •without severe, unstable chronic diseases
- •Polish citizens
排除标准
- •INR > 2 before liposuction
- •primary haematological disease, including hypercoagulable states
- •previous/current history of neoplasm or comorbidity that could impact upon patient's survival
- •pregnancy /lactation
- •alcohol abuse, cocaine amphetamine, etc.
结局指标
主要结局
Electrophysiological improvement
时间窗: 1 year
Improvement in EMG - the appearance of activities in denervated muscles
次要结局
未报告次要终点
研究者
Anna Sarnowska
Head of Translational Platform for Regenerative Medicine MRC
Mossakowski Medical Research Centre Polish Academy of Sciences