An Expanded Access IND to Evaluate the Safety and Efficacy of Autologous HB-adMSCs for the Treatment of a Single Patient With Polyneuropathy
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 Individual Patient Expanded Access IND has been created as requested by an 58-year-old man who suffers from Polyneuropathy due to Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin abnormalities (POEMS) Syndrome. The patient will receive 8 infusions of 200 million cells every four weeks during a 28-week period to relieve the symptoms of Polyneuropathy arising due to POEMS.
详细描述
A screening visit will be conducted to assess the eligibility for this investigation. If the participant qualifies the expanded access program eligibility requirements, he will be treated with the investigational product in the following manner:
The patient will receive 8 infusions of 200 million cells every four weeks during a 28-week period.
This is an Individual Patient Expanded Access IND to evaluate the safety and preliminary efficacy of autologous HB-adMSCs for treating a single patient with Polyneuropathy due to POEMS Syndrome. The expanded access program will include a screening period of up to 28 days, a 28-week treatment period, a safety follow-up, and a 52-week end-of-study visit.
An informed consent form will be given to the participant, who will sign before any procedures.
The informed consent form will include information about this expanded access and all the aspects considered during this process. The following are components of the informed consent process that research personnel should adhere to:
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供