Long Term Follow-up of Patients With Parkinson's Disease Who Had Administered of Allogenic Embryonic Stem Cell-derived A9 Dopamine Progenitor Cell (A9-DPC) in SB-PD-001 Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Adverse Event of Special Interests (AESIs)
研究概览
简要总结
- Long-term follow-up period: Approximately 72 months from the date of approval by the Institutional Review Board (IRB)( Study Period: From the A9-DPC treatment date of the first subject in SB-PD-001 Study* up to 5 years after the A9-DPC treatment of the last subject )
- Objectives: This study aims to evaluate the long-term safety of A9-DPC by following up on the occurrence of adverse event of special interest, (AESI)* for 5 years from A9-DPC treatment date in subjects who have participated in SB-PD-001 Study and received A9-DPC. In addition, it will determine motor and non-motor symptoms over time following A9-DPC treatment, as measured by MDS-UPDRS.
- Methods of the Long-term Follow-up : This is a single center, open-label, 5-year long-term follow-up to evaluate the long-term safety in subjects receiving A9-DPC in SB-PD-001 Study.
Among subjects who have received A9-DPC, those who have provided voluntary written informed consent for participation of the long-term follow-up will be included. The occurrence of AESIs is investigated for 5 years from A9-DPC treatment, and MDS-UPDRS will be conducted for the efficacy assessment if the study can be conducted.
To avoid any missing data about AESIs, a phone or site visit will be performed at least once yearly from the start of the follow-up.
详细描述
- Population of the Long-term Follow-up : Subjects who have participated in SB-PD-001 Study and received A9-DPC (about 12 subjects)
- Long-term Follow-up Period ; Approximately 72 months from the date of approval by the Institutional Review Board (IRB)
- Study Period: From the A9-DPC treatment date of the first subject in SB-PD-001 Study* up to 5 years after the A9-DPC treatment of the last subject
- Study Duration for Individual Subject: 5 years from A9-DPC treatment date * SB-PD-001 Study: Phase 1/2a study of A9-DPC
- Objectives and Endpoints of the Long-term Follow-up ; This study aims to evaluate the long-term safety of A9-DPC by following up on the occurrence of adverse event of special interest, (AESI)* for 5 years from A9-DPC treatment date in subjects who have participated in SB-PD-001 Study and received A9-DPC. In addition, it will determine motor and non-motor symptoms over time following A9-DPC treatment, as measured by MDS-UPDRS.
* AESI is a minimum investigation item to be observed for long-term follow-up of stem cell treatment among the adverse events (AEs) that occur in the subjects receiving treatment. In accordance with the Guideline for Long-term Follow-up of Advanced Biopharmaceuticals distributed by the Ministry of Food and Drug Safety in 2020, it is designated as below in this long-term follow-up. AESIs refer to the serious adverse events (SAEs) in the guideline.
Adverse Event of Special Interests (AESIs)
[Early-onset AESIs (up to 2 years* after the study drug treatment)]
- Infectious diseases
- Complications related to the associated surgical procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who have participated in SB-PD-001 Study and received A9-DPC.
- •Persons who have provided written informed consent for this long-term follow-up.
排除标准
- •Not Applicable
结局指标
主要结局
Adverse Event of Special Interests (AESIs)
时间窗: 5 years after IP administration
Review occurrence of adverse event of special interests (AESIs)
次要结局
- MDS-UPDRS Total Score (defined On/Off)(-Day 14 to -Day 4, 5 years after IP administration)
- MDS-UPDRS Ⅳ score(-Day 14 to -Day 4, 5 years after IP administration)
- MDS-UPDRS part Ⅲ (defined On/Off)(-Day 14 to -Day 4, 5 years after IP administration)